A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease
| Status: | Terminated |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/3/2016 |
| Start Date: | January 2010 |
| End Date: | July 2012 |
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
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.
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.
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 CETP-inhibitor or -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
We found this trial at
40
sites
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