A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease

Phase 3TerminatedNCT01059682

Hoffmann-La Roche936 enrolled

Overview

This multicenter, double-blind, randomized, placebo-controlled study will evaluate the effect of dalcetrapib 600 mg on artherosclerotic disease progression, lipid profile and biomarker profile and long-term safety profile of dalcetrapib in patients with coronary artery disease. Atherosclerotic disease progression will be measured 1. Coronary Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography 2. Carotid B-Mode Ultrasound Intima Medial Thickness (IMT) and total plaque volume in subjects undergoing coronary angiography who have coronary artery disease (CAD). Patients will be randomized to receive dalcetrapib 600 mg orally once a day or placebo. The anticipated time on study treatment will be 24 months. The target sample size is 800-1000 patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

936

Conditions

Cardiovascular Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients over the age of 18 years * Angiographic evidence of coronary artery disease * Ultrasound evidence of carotid artery disease * Treated appropriately for dyslipidemia Exclusion Criteria: * Previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or CETP-vaccine within the last 3 months before study start * Previous coronary artery bypass graft surgery (CABG) or probable need for CABG in the next 24 months * Myocardial infarction in the target coronary artery for IVUS between the initial IVUS examination and randomization * Patients who have symptomatic congestive heart failure at baseline (New York Heart Association class III or IV) * Severe anemia * Uncontrolled hypertension * Poorly controlled diabetes

Locations (110)

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Torrance, California, United States

Unnamed facility

Boulder, Colorado, United States

Unnamed facility

Greeley, Colorado, United States

Unnamed facility

Outcomes

Primary Outcomes

Nominal Change From Baseline to Study End in Coronary Percent Atheroma Volume (PAV) of the Target Coronary Artery Assessed by IVUS.

Time frame: 24 months

Rate of Change From Baseline to Study End in Carotid Intima-media Thickness (CIMT) Using B-mode Ultrasound

Time frame: 24 months

Secondary Outcomes

Nominal Changes From Baseline in Minimal Lumen Diameter as Assessed by Quantitative Coronary Angiography

Time frame: 24 months

Blood Lipids, Lipoproteins

Time frame: Throughout study, 24 months

Nominal Changes in Percent Diameter Stenosis as Assessed by Quantitative Coronary Angiography

Time frame: Throughout Study, 24 months