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

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Center, Double-blind, Randomized, Placebo Controlled, Parallel Group Study of the Effect of Dalcetrapib on Atherosclerotic Disease Progression As Measured by Coronary Intravascular Ultrasound, Carotid B-Mode Ultrasound and Coronary Angiography

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Drug: Dalcetrapib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dalcetrapib<br> | Drug: Dalcetrapib<br>* Dalcetrapib 600 mg orally once daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo orally once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nominal Change From Baseline to Study End in Coronary Percent Atheroma Volume (PAV) of the Target Coronary Artery Assessed by IVUS. |  | 24 months | 
| Rate of Change From Baseline to Study End in Carotid Intima-media Thickness (CIMT) Using B-mode Ultrasound |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nominal Changes From Baseline in Minimal Lumen Diameter as Assessed by Quantitative Coronary Angiography |  | 24 months | 
| Blood Lipids, Lipoproteins |  | Throughout study, 24 months | 
| Nominal Changes in Percent Diameter Stenosis as Assessed by Quantitative Coronary Angiography |  | Throughout Study, 24 months |