Completed Clinical Trials

Listed below are recently completed clinical trials.  For currently enrolling studies, please go to the ECCRI Clinical Trials page.

ALLSTAR

Randomized, Double-Blind, Placebo-Controlled Phase I/II Study of the Safety and Efficacy of Intracoronary Delivery of Allogeneic Cardiosphere-Derived Cells in Patients With an Anterior Myocardial Infarction and Ischemic Left Ventricular Dysfunction (ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration, ALLSTAR)

Sponsor: Capricor, Inc.

PI: Arshed Quyyumi, MD

Purpose: The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial infarction.

This study is closed to enrollment.

AEGIS-1

A Phase 2b, Multi-center, Randomized, Placebo-controlled, Dose-ranging Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects with Acute Myocardial Infarction

Sponsor: CSL Behring, LLC

PI: Arshed Quyyumi, MD

Purpose: This is a multicenter randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 compared with placebo in subjects with acute myocardial infarction (AMI).

This study is closed to enrollment.

ELIXA

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter StudyTo Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide In Type 2 Diabetic Patients After An Acute Coronary Syndrome

Sponsor: Sanofi

PI: Arshed Quyyumi, MD

Purpose: The purpose of this study is to evaluate the safety and Effectiveness of LIXisenatide in Acute coronary syndrome.

This study is closed to enrollment.

Etanercept

Etanercept and Vascular Function in Psoriasis

Sponsor: Amgen

PI: Arshed Quyyumi, MD

Purpose: To investigate whether etanercept therapy will improve endothelial dysfunction in patients with psoriasis.

This study is closed to enrollment.

HIVasc

Injury and Repair Factors promoting Atherosclerosis in HIV

Sponsor: NIH: NHLBI

PI: Arshed Quyyumi, MD

Purpose: The main goal of this study is to investigate the molecular and regenerative pathways and their interactions in HIV-infected subjects, and their influence on risk of presence and progression of vascular disease in this population.

This study is closed to enrollment.

Nebivolol

The Effect of Nebivolol on Endothelial Dysfunction in African Americans With Hypertension

Sponsor: Emory University

PI: Arshed Quyyumi, MD

Purpose: Nebivolol is a medication that has been recently approved by the FDA for the treatment of hypertension. Our study will investigate whether treatment with nebivolol, as compared to another medication called metoprolol, in African Americans with hypertension will be more effective in protecting blood vessels against the harmful effects of high blood pressure.

This study is closed to enrollment.

Preserve

A Prospective Randomized Double Blinded Placebo Controlled Phase II Trial of Intra-coronary Infusion of AMR-001, a Bone Marrow Derived Autologous CD34+ Selected Cell Product, in Patients with Acute Myocardial Infarction

Sponsor: Amorcyte

PI: Arshed Quyyumi, MD

Purpose: The primary objective of the study is to determine the feasibility and safety of prospectively identifying patients at risk for clinically significant cardiac dysfunction following a myocardial infarction and the ability to isolate and infuse via the affected coronary circulation an autologous bone marrow derived CD34+ cell product at four dose levels.

The secondary objective of the study is to assess the effect on cardiac function and infarct region perfusion. A concurrent patient group meeting eligibility but not receiving CD34+ cells will be evaluated similar to the treated group to assess the rate of significant spontaneous improvement in cardiac function without CD34+cell infusion.

This study is closed to enrollment.

RENEW

A Prospective, Randomized, Double-Blinded, Active-Control And Unblinded Standard Of Care (SOC) Controlled Study To Determine The Efficacy And Safety Of Targeted Intramyocardical Delivery Of Autologous CD34+ Cells (Auto CD34+ Cells) For Increasing Exercise Capacity During Standardized Exercise Testing In Subjects With Refractory Angina Pectoris And Chronic Myocardial Ischemia (CMI)

Sponsor: Baxter

PI: Arshed Quyyumi, MD

Purpose: The purpose of the study is to assess the safety and efficacy of targeted intramyocardial delivery of Auto-CD34+ cells for increasing exercise time and amelioration of anginal symptoms in subjects with refractory angina and chronic myocardial ischemia.

This study is closed to enrollment.

STEMI

A PHASE IIa, DOUBLE-BLINDED, PLACEBO- CONTROLLED, MULTI-CENTER, RANDOMIZED STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PRELIMINARY EFFICACY OF A SINGLE INTRAVENOUS DOSE OF ALLOGENEIC MESENCHYMAL BONE MARROW CELLS TO SUBJECTS WITH ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI)

Sponsor: CardioCell, LLC.

PI: Michael McDaniel, MD

Purpose: The purpose of this study is to assess the safety and tolerability of human allogeneic mesenchymal bone marrow cells (aMBMC) administered intravenously to subjects with ST Segment Elevation Myocardial Infarction (STEMI).

This study is no longer open for enrollment.

TRILOGY ACS

A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS) Subjects with Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) Who are Medically Managed – The TRILOGY ACS Study

Sponsor: Eli Lilly and Company

PI: Arshed Quyyumi

Purpose: This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).

This study is no longer open for enrollment.