Clinical Trials

Emory Cardiovascular Biobank

Sponsor: Emory University

Purpose: Emory Cardiovascualr Biobank is a prospective study of patients who undergo cardiac catheterization for suspected coronary artery disease which investigates the role of novel biomarkers in relation to cardiovascular risk. More information about this study

Inclusion Criteria:

Patients with active cardiovascular disease including but not limited to

• Ischemic Heart Disease
• Heart Failure and Cardiomyopathies
• Peripheral Vascular Disease
• Valve disease
• Adult Congenital Heart disease
• Electrophysiological Disorders

Principal Investigator: Arshed Quyyumi

Research Coordinator: Nisreen Haroun

Status: Enrolling

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

Sponsor: Ionis Pharmaceuticals, Inc.

Purpose: The purpose of this study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

Inclusion Criteria:

1. Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification
2. Participants must be on lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. Lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to screening to minimize changes in these medications during the study.
3. Participants must be willing to comply with diet and lifestyle recommendations as able.

Exclusion Criteria:

1. Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
2. Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal
3. Total bilirubin > 1.5 ULN unless due to Gilbert's syndrome
4. Estimated GFR < 30 mL/min/1.73 m^2

Principal Investigator: Arshed A. Quyyumi, MD

Research Coordinator: Tanveer Kauser

Status: Enrolling 

DAPA ACT HF-TIMI 68: Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure Thrombolysis in Myocardial Infarction 68

Sponsor: AstraZeneca

Purpose: To evaluate the effect of in-hospital initiation of dapagliflozin versus placebo on the clinical outcome of cardiovascular death or worsening heart failure.

Inclusion Criteria:

1. Age 18 years (male or female)
2. Currently hospitalized for AHF defined as meeting all the following criteria:
   1. Presentation with worsening symptoms of heart failure (e.g., worsening dyspnea or dyspnea at rest, progressive fatigue, rapid weight gain, worsening edema/abdominal distention/anasarca)
   2. Objective signs or diagnostic testing consistent with volume overload (e.g., jugular venous distension, pulmonary basilar crackles, S3 gallop, ascites, hepatomegaly, peripheral edema, radiological evidence of pulmonary congestion, noninvasive or invasive hemodynamic evidence of elevated filling pressures)
   3. Intensification of AHF therapy during admission defined as at least one of the following:
      1. Augmentation of oral diuretic therapy [e.g., 2x outpatient regimen dose, addition of a second diuretic agent, or new initiation of diuretic therapy in a previously naïve patient]
      2. Initiation of intravenous diuretic therapy

• Initiation of intravenous vasoactive agent (e.g., inotrope or vasodilator)

3. Left ventricular ejection fraction (LVEF) measured within the past 12 months (including during the current hospitalization)
4. Elevated NT-proBNP or BNP during current hospitalization:
   1. For patients with LVEF 40%: NT-proBNP  1600 pg/mL or BNP  400 pg/mL (NT-proBNP  2400 pg/mL or BNP  600 pg/mL if patient in atrial fibrillation or atrial flutter)
   2. For patients with LVEF > 40%: NT-proBNP 120 pg/mL or BNP  300 pg/mL (NT-proBNP  1800 pg/mL or BNP  450 pg/mL if patient in atrial fibrillation or atrial flutter)
5. Eligible patients will be randomized no earlier than 24 hours and up to 14 days after presentation while still hospitalized once they have been stabilized, as defined by:
   1. No increase (i.e., intensification) in the dose of intravenous diuretics during the 12 hours prior to randomization
   2. No use of intravenous vasodilators or inotropes during the 24 hours prior to randomization

Exclusion Criteria:

1. Symptomatic hypotension in the past 24 hours
2. Concurrent use of two or more intravenous inotropic agents during the index hospitalization
3. eGFR <25 ml/min/1.73 m² as measured by the CKD-EPI equation at screening or rapidly progressive renal disease
4. Current use of an SGLT2 inhibitor
5. Prior intolerance of SGLT2 inhibitors
6. Type 1 diabetes mellitus or history of diabetic ketoacidosis
7. (Only applies to patients with T2DM who are on insulin and/or a sulfonylurea) History of recurrent major hypoglycemia (i.e., resulting in severe impairment in consciousness or behavior, or requiring emergency external assistance)
8. Implantation of a cardiac resynchronization therapy (CRT) device or valve repair or replacement within 30 days prior to randomization or intent to do so during the trial
9. ST-segment elevation myocardial infarction or coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) within 30 days prior to randomization or intent to undergo coronary revascularization during the trial
10. Untreated sustained ventricular arrhythmias or Mobitz type II or third-degree heart block (i.e., without an ICD or pacemaker, respectively)
11. History of heart transplantation or current transplant listing; mechanical circulatory support use (either durable or temporary) during the index hospitalization
12. History of heart failure due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, uncorrected primary valvular disease, complex congenital heart disease, or heart failure felt to be due to a transient process (e.g., stress [takotsubo] cardiomyopathy, tachycardia-induced cardiomyopathy) expected to resolve within 2 months
13. History of end-stage liver disease
14. Women of child-bearing potential (unless using adequate contraception) or currently breastfeeding
15. Current participation in a clinical trial with an unlicensed drug or device
16. Study staff or their family members
17. Any condition that, in the opinion of the investigator would make trial participation not in the best interest of the subject, or would compromise compliance with the trial protocol (e.g., active severe infection, active malignancy)

Principal Investigator: Modele Ogunniyi MD, MPH

Coordinators:Alexus Locke, TaCoria Williams

Status: Enrolling

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM (FOREST-HCM)

Sponsor: Cytokinetics

Purpose: The purpose of this study is to collect long-term safety and tolerability data for aficamten (CK-3773274)

Inclusion Criteria:

• Completion of a Cytokinetics trial investigating CK-3773274
• LVEF ≥55% at the Screening Visit

Exclusion Criteria:

• Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor.
• Has participated in another investigational device or drug study or received an investigational device or drug < 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.

• Since completion of a previous trial of CK-3773274 has:

  • Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) <30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) <100 bpm and/or rhythm is stable >30 days
  • Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation) since the completion of a prior trial of CK-3773274.
• Had a confirmed LVEF <40% with an associated dose interruption during participation in a prior study with CK-3773274
• History of appropriate ICD shock within 30 days prior to screening

Principal Investigator: Ozlem Bilen, MD

Research Coordinator: Shaimaa Sakr

Status: Enrolling by Invitation

GARDEN-TIMI 74: A Phase 2 Study of the Effects of Ponsegromab on Health-Related Quality of Life and Safety in Patients With Heart Failure

Sponsor: Pfizer

Purpose: To investigate Symptoms, Function, Health-Related Quality of Life, and Safety, With Repeated Subcutaneous Administration of Ponsegromab Versus Placebo in Adult Participants With Heart Failure

Inclusion Criteria:

1. Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening.
   1. A female participant is eligible to participate if she is not pregnant or breastfeeding
2. Clinical evidence of HF with each of the following criteria:
   1. LVEF <50% on most recent measurement, within 12 months of screening

An assessment of LVEF in the prior 12 months is not required in situations where LVEF has been persistently <50% on prior assessments obtained at least 3 months apart (including the most recent measurement)

1. NYHA class II-IV at screening
2. Main cohort only: NT-proBNP 400 pg/mL at screening

3. Serum GDF-15 concentration 2000 pg/mL at screening
4. Main cohort only: KCCQ-23 CSS < 75 at screening
5. Main cohort only: Evidence of cachexia or fatigue or functional impairment, as demonstrated by at least 1 of the following at screening:
   1. Non-edematous unintentional weight loss 5% in the last 6 months or current BMI < 20% kg/m² , associated with subjective fatigue or anorexia; or
   2. Fatigue at least 3 times per week AND at least moderately bothersome fatigue in the past 2 weeks based on the KCCQ-23 administered at screening; or
   3. A score < 60 on the Physical Limitations Domain of the KCCQ-23 administered at screening
6. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures (including but not limited to subcutaneous injection of study intervention)

Exclusion Criteria:

1. Acute decompensated HF within 1 month prior to SV1 or during the screening period
2. Implantation of a cardiac resynchronization therapy device or valve repair or replacement within 3 months prior to randomization or intent to do so during the trial
   1. For the open-label, PK cohort only: implantation of a cardiac resynchronization therapy device more than 1 month prior to randomization is permitted
3. History of heart transplantation, currently listed for heart transplant, current/planned mechanical circulatory support, or current/planned use of intravenous inotropes (eg, dobutamine, milrinone)
4. Acute coronary syndrome within 1 month prior to randomization
5. Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) within 3 months prior to randomization or intent to undergo coronary revascularization during the trial
   1. For the open-label, PK cohort only: coronary revascularization more than 1 month prior to randomization is permitted
6. Untreated indication for an implantable cardiac defibrillator or pacemaker to treat a cardiac rhythm, abnormality (ie, tachyarrhythmia or bradyarrhythmia)
7. History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibody
8. Other medical (eg, severe, uncorrected aortic stenosis; active malignancy) or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, may limit life expectancy to less than 1 year and/or make the participant inappropriate for the study
9. Current use of any prohibited concomitant medication(s)
10. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Treatment with an investigational biotherapeutic agent within 6 months or 5 half-lives (whichever is longer) of Day 1
11. Previous exposure to posegromab in a prior clinical study
12. Renal disease requiring ongoing dialysis
13. Cirrhosis with evidence of portal hypertension not due to HF, or the following LFT abnormalities at the time of screening, confirmed by a repeat test if deemed necessary: AST or ALT level 3 x ULN, or total bilirubin level  2 x ULN (unless history of Gilbert’s syndrome)
14. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members

Principal Investigator: Modele Ogunniyi MD, MPH

Coordinators: Alexus Locke, TaCoria Williams

Status: Enrolling

Granulocyte Macrophage Stimulating Factor (GM-CSF) in Peripheral Artery Disease

Sponsor:  NIH: NHLBI

Purpose:  This study is investigating whether GM-CSF (granulocyte-macrophage colony stimulating factor or Sargramostim) improves symptoms and blood flow in people with Peripheral Artery Disease (PAD). More information about this study

Inclusion Criteria:

• Angiographically documented PAD.
• Clinically stable (>2 months) history of intermittent claudication or walking impairment (Rutherford Class II) with no change in symptom severity in the 2 months prior to screening.
• On stable statin therapy for previous 3 months.
• Peak Walking Time (PWT) between 1 and 12 minutes on a standardized Gardner treadmill protocol. 
• A Doppler-derived ankle-brachial index (ABI) of < 0.90 in the symptomatic limb after 10 minutes of rest at screening.  For subjects with an ABI of >1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of < 0.70 must be obtained for subject qualification, or if ABI is > 0.9 to 1.0 , and a reduction of 20% in ABI measured within 1 minute of treadmill testing. 
• On appropriate and stable medical therapy for atherosclerosis for > 2 months.

Principal Investigator: Arshed Quyyumi, MD
Research Coordinator: Yazan Haroun
Status: Enrolling

A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With Established Cardiovascular Disease

Sponsor: Novartis Pharmaceuticals

Purpose: This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

Inclusion Criteria

• Lp(a) ≥ 70 mg/dL at the screening visit, measured at the Central laboratory
• Myocardial infarction: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
• Ischemic stroke: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
• Clinically significant symptomatic peripheral artery disease

Exclusion Criteria

• Uncontrolled hypertension
• Heart failure New York Heart Association (NYHA) class IV
• History of malignancy of any organ system
• History of hemorrhagic stroke or other major bleeding
• Platelet count ≤LLN
• Active liver disease or hepatic dysfunction
• Significant kidney disease
• Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply at the end.

Principal Investigator: Ijeoma Isiadinso

Study Coordinator: Muhammad Owais

Status: Enrollment Closed

Specimen Collection for the Evaluation of Alere NT-proBNP for Alinity i System in an Outpatient Setting for Heart Failure (LANAIS-HF)

Sponsor: Abbott Laboratories

Purpose: The objective of this study is to collect and bank K2-ethylenediaminetetraacetic acid (K2EDTA) plasma to evaluate the clinical utility of the Alere NT-proBNP for Alinity i system assay as an aid in the diagnosis and assessment of severity of individuals suspected or having heart failure.

Principal Investigator: Arshed Quyyumi, MD

Research Coordinator: Muhammad Owais

Status: Enrolling

Specimen Collection for the Evaluation of Alere NT-proBNP for Alinity i System in an Emergency Deparment Setting for Heart Failure

Sponsor: Abbott Laboratories

Purpose: The objective of this study is to collect and bank K2-ethylenediaminetetraacetic acid (K2EDTA) plasma to evaluate the clinical utility of the Alere NT-proBNP for Alinity i system assay as an aid in the diagnosis and assessment of severity of individuals suspected or having heart failure.

Principal Investigator: Arshed Quyyumi, MD

Research Coordinator: Muhammad Owais

Status: Enrollment Closed

Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM (MAPLE-HCM)

Sponsor: Cytokinetics

Purpose: The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction.

Inclusion Criteria:

• Participants who meet all the following criteria at screening may be included in the trial:

  • Males and females between 18 to 85 years of age, inclusive, at screening
  • Body mass index < 35 kg/m2

  • Diagnosed with oHCM per the following criteria by cardiac magnetic resonance imaging (CMR) or echocardiography -

    • Has left ventricular (LV) hypertrophy with non-dilated LV chamber in the absence of other cardiac disease and

    • Has an end-diastolic LV wall thickness as measured by the echocardiography core laboratory:

      1. ≥ 15 mm in one or more myocardial segments OR
      2. ≥ 13 mm in one or more wall segments and a known disease-causing gene mutation or positive family history of HCM
  • NYHA class II or III

  • Has a screening echocardiogram with the following determined by the echocardiography core laboratory:

    • Resting LVOT-G > 30 mm Hg and/or post-Valsalva LVOT-G ≥ 50 mmHg at screening AND
    • LVEF ≥ 60%
  • Hemoglobin ≥ 10g/dL
  • Patients previously exposed to mavacamten are allowed to participate but must be off mavacamten for at least 8 weeks

Exclusion Criteria:

• Any of the following criteria will exclude potential participants from the trial:

  • Medical indication for either beta blocker or calcium-channel blockers prohibiting drug discontinuation other than oHCM
  • History of intolerance or medical contraindication to beta blocker therapy
  • Resting SBP of > 160 mmHg
  • Resting heart rate of > 100 bpm

  • Significant valvular heart disease

    1. Moderate-severe valvular aortic stenosis or fixed subaortic obstruction
    2. Mitral regurgitation not due to systolic anterior motion of the mitral valve (per Investigator judgment)
  • Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis)
  • History of LV systolic dysfunction (LVEF < 45%) or stress cardiomyopathy at any time during their clinical course
  • Inability to exercise on a treadmill or bicycle (eg, orthopedic limitations)
  • Documented room air oxygen saturation reading < 90% at screening
  • Planned septal reduction treatment that cannot be deferred during the trial period
  • History of septal reduction therapy (surgical myectomy or alcohol septal ablation) within 6 months of screening
  • History of paroxysmal or persistent atrial fibrillation or atrial flutter. Atrial flutter treated with radio frequency ablation without recurrence within the last 6 months prior to screening is allowed.
  • Current or recent (< 4 weeks) therapy with disopyramide
  • History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening
  • Has received prior treatment with aficamten or previously intolerant (reduced LVEF requiring permanent drug discontinuation) to mavacamten

Principal Investigator: Ozlem Bilen, MD

Study Coordinator: Shaimaa Sakr

Status: Enrolling

A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy (Odyssey HCM)

Sponsor: Bristol-Myers Squibb

Purpose: The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).

Inclusion Criteria

• Diagnosis of HCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines: unexplained left-ventricular hypertrophy with non-dilated ventricular chambers in the absence of other cardiac or systemic disease which can produce the required magnitude of hypertrophy of a maximal left ventricular (LV) wall thickness ≥ 15 millimeters (mm) (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy [HCM]) as determined by core laboratory interpretation.
• Peak left ventricular outflow tract (LVOT) pressure gradient < 30 millimeters mercury (mm Hg) at rest and < 50 mm Hg with provocation (Valsalva maneuver and stress echocardiography).
• New York Heart Association (NYHA) Class II or III.

Exclusion Criteria

• Known infiltrative or storage disorder causing cardiac hypertrophy that mimics non-obstructive hypertrophic cardiomyopathy (nHCM) such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy.
• History of unexplained syncope within 6 months prior to screening.
• History of sustained ventricular tachyarrhythmia (> 30 seconds) within 6 months prior to screening.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Principal Investigator: Ozlem Bilen

Study Coordinator: Shamim Hasnain

Status: Enrolling

Use of Biomarker Risk Score to Optimize Therapy in Patients with Coronary Artery Disease: The Precision CAD Trial

Purpose: The purpose of this study is to see if a customized treatment based on biomarkers will reduce the biomarker levels and lead to lower risk of complications from CAD.

Inclusion Criteria:

• individuals aged 21-90 years with stable CAD.
• Patients with plaque at angiography exceeding >50% in one or more coronary arteries at any time will be eligible. Current obstructive CAD is not required for eligibility.
• Patients undergoing revascularization therapy or recent acute coronary syndrome (ACS) will be eligible for recruitment and will be recruited at least 4 weeks after admission for an ACS or percutaneous intervention and 3 months after coronary bypass graft surgery.

Principal Investigator: Arshed A. Quyyumi, MD

Research Coordinator: Ayman Alkhoder

Status: Enrolling

SmartHF: The impact of an adaptive patient-centered web application on medication optimization in HFrEF patients

Sponsor: AHRQ

Purpose: To investigate the effectiveness of an adaptive web application to facilitate guideline-directed medical therapy (GDMT) optimization in HFrEF

Inclusion Criteria:

1. Age 18 years and older at screening
2. Diagnosis of heart failure with a left ventricular ejection fraction (LVEF) </= 40% (HFrEF)
3. Have a general medicine provider or general cardiology provider for HFrEF
4. Have internet access and access to their health system’s patient portal
5. Fluent in spoken and written English
6. At least two of the following: systolic blood pressure 110mmg, potassium  5, serum creatinine  2.5, heart rate  70
7. At least two eligible heart failure therapies (guideline-recommended BB, RASI, MRA, or SGLT2i) not yet initiated or below 50% of the target dose

Exclusion Criteria:

1. End-stage hf (hospice candidate)
2. Actively treated cancer, except non-melanoma skin cancer
3. Implanted ventricular assist device
4. Current treatment with chronic inotropic therapy
5. Patient’s provider for HFrEF care is considered an advanced HF specialist
6. Currently pregnant or intends to become pregnant during the study period
7. Dialysis

Principal Investigator: Modele Ogunniyi MD,MPH

Coordinators: Alexus Locke, TaCoria Williams

Status: Enrolling

Smartphone Delivered In-home Cardiopulmonary Rehabilitation

Purpose: The goal of this study is to determine if a remote cardiac or pulmonary rehabilitation program delivered via a smartphone application and regular telephone calls will lead to improved patient outcomes as measured by functional capacity, improved patient compliance in monitoring symptoms and medication adherence, improved self-efficacy and knowledge in managing disease and, a decreased rate of hospitalization and re-admissions.

Inclusion Criteria: 

1. Following acute myocardial infarction (within the preceding 12 months)
2. Coronary artery bypass grafting (CABG)
3. Current stable angina pectoris
4. Heart valve repair or replacement
5. Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting
6. Heart or heart-lung transplant
7. Other diagnosis by specific physician referral

Principal Investigator: Amit Shah, MD, MSc

Status: Enrolling

Smartphone-Enabled Supervised Exercise Therapy for the Treatment of Symptomatic Peripheral Arterial Disease

Purpose: The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care).

Inclusion Criteria:
•Clinically stable intermittent claudication
•Able to give informed consent
•Age 18-89 years

And one of the following:
•ABI < 0.9 after 10 minutes of rest OR
•For subjects with an ABI of >1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of < 0.70 must be obtained for subject qualification. If ABI is > 0.9 to 1.0, a reduction of 20% in ABI must be measured within 1 minute of treadmill testing.

Principal Investigator: Amit Shah, MD, MSc

Status: Enrolling

A Randomized, Controlled, Multicenter, Open-label Trial Comparing a Hospital Post-discharge Care Pathway Involving Aggressive LDL-C Management That Includes Inclisiran With Usual Care Versus Usual Care Alone in Patients With a Recent Acute Coronary Syndrome(VICTORION-INCEPTION)

Sponsor: Novartis Pharmaceuticals

Purpose: The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug.

Inclusion Criteria:

• Recent Acute Coronary Syndrome (in-patient/out-patient) within 5 weeks of screening
• Serum LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL
• Fasting triglycerides <4.52 mmol/L (<400 mg/dL) at screening
• Calculated glomerular filtration rate >20 mL/min by estimated glomerular filtration rate (eGFR)
• Participants are required to be discharged on statin therapy, or have documented statin intolerance, as determined by the investigator, following hospitalization for an ACS. Statin intolerant patients are eligible if they had intolerable side effects on at least 2 different statins, including one at the lowest standard dose

Exclusion Criteria:

• New York Heart Association (NYHA) class IIIb or IV heart failure or last known left ventricular ejection fraction <25%.
• Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening.
• Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.
• Treatment with other investigational products or devices within 30 days or five half˗lives of the screening visit, whichever is longer.
• Planned use of other investigational products or devices during the course of the study.
• Treatment with monoclonal antibodies directed towards PCSK9 within 90 days of screening.
• Recurrent ACS event within 2 weeks prior to randomization.
• Coronary angiography and revascularization procedure (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) surgery) performed within 2 weeks prior to the randomization visit or planned after randomization.

Principal Investigator: Arshed A. Quyyumi, MD

Research Coordinator: Tanveer Kauser

Status: Enrollment Closed