Cardiovascular Research Unit
Clinical Trials and Registries

CORONARY ARTERY DISEASE

CURRENT
Randomized, multinational, double-blind study, comparing a high loading dose regimen of clopidogrel versus standard dose in patients with unstable angina or non-ST segment elevation myocardial infarction managed with an early invasive strategy

Principal Investigator
Anilkumar Mehra, M.D.

Study Coordinator
Cesar Ochoa

Purpose
The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin will decrease the risk of ischemic complications, defined as cardiac death, stroke, myocardial infarction, after a percutaneous coronary intervention (PCI) in patients with Acute Coronary Syndrome (ACS) . Clopidogrel is approved by the FDA. However, the use of clopidogrel in this study is considered experimental because the FDA has not approved clopidogrel in the doses that will be used in this study.

Enrollment Status: OPEN

CYPRESS
A Prospective, Randomized, MultiCenter, Double-Blind Trial to Assess the Effectiveness and Safety of Different Durations of Dual Anti-Platelet Therapy (DAPT) in Subjects Undergoing PCI with the CYPHER ® Sirolimus-eluting Coronary Stent

Principal Investigator
Ray Matthews, M.D.

Study Coordinators
Karen Adams
Stephanie Mullin, R.N.

Study Summary
Coronary artery disease is the build-up of fatty substances (such as cholesterol) along the lining of the coronary arteries that reduces blood flow and deprives the heart of oxygen. If blood flow through the arteries is reduced, the heart muscle may not receive enough oxygen, and chest pain (angina) may result. A heart attack occurs when an artery becomes severely blocked. In order to restore blood flow to the heart, a stent is placed inside the narrowed artery of the heart (coronary artery) to help keep it open. In this research study we will be using a coronary artery stent coated with a drug called sirolimus. Sirolimus is a drug approved by the Food and Drug Administration (FDA) which has been proven to slow down or prevent the coronary arteries from closing again.

The Cypher® Sirolimus-Eluting Stent is an FDA approved drug-coated coronary artery stent. The purpose of this study is to collect data (information) from people with coronary artery disease who are treated with a CYPHER® stent.

We also hope to learn how long patients with this type of stent should remain on a blood thinner (aspirin) and a second medication (either clopidogrel [Plavix] or prasugrel [Effient]) that prevents the blood from clotting. Aspirin taken with either clopidogrel or prasugrel is commonly called “dual anti-platelet therapy.” It is believed that the risk of experiencing a clot to a stent after it has been implanted can be lowered by taking blood thinning medications with aspirin for an extended period of time.

Blood thinning medications in combination with aspirin have been shown to provide more protection against a future heart attack and the formation of clots that could possibly clog a stent than aspirin alone. Blood thinning medications, taken with aspirin, help increase this protection by going beyond what aspirin and other heart medications do alone to help keep blood platelets from sticking together and forming clots.

Enrollment Status: Pending IRB Approval

DalPLAQUE II
A Phase IIIB MultiCenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Effect of Treatment with Dalcetrapib 600 mg on Atherosclerotic Disease as Measured by Intravascular Ultrasound, Quantitative Coronary Angiography, Carotid B-Mode Ultrasound Intima Medial Thickness and Total Plaque Volume in Subjects Undergoing Coronary Angiography Who Had Coronary Artery Disease

Principal Investigator
Leonardo Clavijo, M.D.

Study Coordinator
Cesar Ochoa

Study Summary
This study is about an experimental drug call dalcetrapib. An “experimental drug” means it has not been approved by the U.S. Food and Drug Administration (FDA). Dalcetrapib belongs to a new class of drugs called CETP inhibitors that increases the so-called “good” cholesterol.

“CETP” stands for cholesteryl ester transfer protein. This protein is considered bad because it moves cholesterol from the good form to the bad form. It is now recognized that bad cholesterol causes heart disease and that raising good cholesterol levels can actually help to lower and even reverse the bad effects of the bad cholesterol. Inhibiting the CETP is a way to possibly increase good cholesterol levels. It has been shown that high levels of good cholesterol may decrease the risk of heart disease.

This study is also an imaging study that will use imaging technology to look at atherosclerosis (hardening or narrowing) in the coronary and carotid arteries. The imaging methods used in this study include intravascular ultrasound (IVUS) and carotid intima media thickness ultrasound (CIMT). Following 24 months of study drug dosing, a repeat coronary angiogram will be done for research purposes only.

Enrollment Status: OPEN