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

NCT ID: NCT01059682

Last Updated: 2020-03-24

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

936 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-09-30

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.

Detailed Description

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Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dalcetrapib

Group Type EXPERIMENTAL

Dalcetrapib

Intervention Type DRUG

Dalcetrapib 600 mg orally once daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo orally once daily

Interventions

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Dalcetrapib

Dalcetrapib 600 mg orally once daily

Intervention Type DRUG

Placebo

Placebo orally once daily

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Los Angeles, California, United States

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Los Angeles, California, United States

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Torrance, California, United States

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Boulder, Colorado, United States

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Greeley, Colorado, United States

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Littleton, Colorado, United States

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Hartford, Connecticut, United States

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Atlantis, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Decatur, Georgia, United States

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Chicago, Illinois, United States

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Elkhart, Indiana, United States

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Louisville, Kentucky, United States

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Columbia, Maryland, United States

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Salisbury, Maryland, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Kalamazoo, Michigan, United States

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Midland, Michigan, United States

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Muskegon, Michigan, United States

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Petoskey, Michigan, United States

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Duluth, Minnesota, United States

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Rochester, Minnesota, United States

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Kansas City, Missouri, United States

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Paramus, New Jersey, United States

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New York, New York, United States

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Rochester, New York, United States

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Chapel Hill, North Carolina, United States

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Toledo, Ohio, United States

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Hershey, Pennsylvania, United States

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Providence, Rhode Island, United States

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Germantown, Tennessee, United States

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Oak Ridge, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Richmond, Virginia, United States

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Edmonton, Alberta, Canada

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Edmonton, Alberta, Canada

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New Westminster, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Saint John, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Brampton, Ontario, Canada

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Burlington, Ontario, Canada

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Cambridge, Ontario, Canada

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Hamilton, Ontario, Canada

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Kitchener, Ontario, Canada

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London, Ontario, Canada

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Mississauga, Ontario, Canada

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Newmarket, Ontario, Canada

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Oshawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Fleurimont, Quebec, Canada

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Gatineau, Quebec, Canada

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Greenfield Park, Quebec, Canada

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Lachine, Quebec, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Saint Georges-de-beauce, Quebec, Canada

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Saint-Charles-Borromée, Quebec, Canada

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Saint-Jérôme, Quebec, Canada

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Saint-Lambert, Quebec, Canada

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Ste. Foy, Quebec, Canada

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Sudbury, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Val-d'Or, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Aachen, , Germany

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Berlin, , Germany

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Darmstadt, , Germany

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Essen, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Leipzig, , Germany

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München, , Germany

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München, , Germany

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Regensburg, , Germany

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Ulm, , Germany

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Elblag, , Poland

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Gdansk, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Geneva, , Switzerland

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Kreuzlingen, , Switzerland

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Zurich, , Switzerland

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Countries

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United States Canada Germany Poland Switzerland

References

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Tardif JC, Rhainds D, Brodeur M, Feroz Zada Y, Fouodjio R, Provost S, Boule M, Alem S, Gregoire JC, L'Allier PL, Ibrahim R, Guertin MC, Mongrain I, Olsson AG, Schwartz GG, Rheaume E, Dube MP. Genotype-Dependent Effects of Dalcetrapib on Cholesterol Efflux and Inflammation: Concordance With Clinical Outcomes. Circ Cardiovasc Genet. 2016 Aug;9(4):340-8. doi: 10.1161/CIRCGENETICS.116.001405. Epub 2016 Jul 14.

Reference Type DERIVED
PMID: 27418594 (View on PubMed)

Tardif JC, Rheaume E, Lemieux Perreault LP, Gregoire JC, Feroz Zada Y, Asselin G, Provost S, Barhdadi A, Rhainds D, L'Allier PL, Ibrahim R, Upmanyu R, Niesor EJ, Benghozi R, Suchankova G, Laghrissi-Thode F, Guertin MC, Olsson AG, Mongrain I, Schwartz GG, Dube MP. Pharmacogenomic determinants of the cardiovascular effects of dalcetrapib. Circ Cardiovasc Genet. 2015 Apr;8(2):372-82. doi: 10.1161/CIRCGENETICS.114.000663. Epub 2015 Jan 11.

Reference Type DERIVED
PMID: 25583994 (View on PubMed)

Other Identifiers

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NC22703

Identifier Type: -

Identifier Source: org_study_id

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