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

Phase 3

Terminated

• Conditions: Cardiovascular Disease
• Interventions: Drug: Dalcetrapib; Drug: Placebo

• Registration Number: NCT01059682
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-29
• Study First Submitted QC: 2010-01-29
• Study First Posted: 2010-02-01
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Disposition First Submitted: 2016-07-26
• Disposition First Submitted QC: 2016-07-26
• Disposition First Posted: 2016-07-28
• Results First Submitted: 2019-07-17
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-20
• Last Update Submitted: 2020-03-20
• Results First Posted: 2020-03-24
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 936

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dalcetrapib	Dalcetrapib	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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