Clinical trial NCT01059682: A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cardiovascular Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-02-01
Enrollment: 936
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Nominal Change From Baseline to Study End in Coronary Percent Atheroma Volume (PAV) of the Target Coronary Artery Assessed by IVUS.
timeFrame: 24 months
measure: Rate of Change From Baseline to Study End in Carotid Intima-media Thickness (CIMT) Using B-mode Ultrasound
timeFrame: 24 months
Secondary outcomes:
measure: Nominal Changes From Baseline in Minimal Lumen Diameter as Assessed by Quantitative Coronary Angiography
timeFrame: 24 months
measure: Blood Lipids, Lipoproteins
timeFrame: Throughout study, 24 months
measure: Nominal Changes in Percent Diameter Stenosis as Assessed by Quantitative Coronary Angiography
timeFrame: Throughout Study, 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Torrance
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Greeley
country: United States
state: Colorado
city: Littleton
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
city: Atlantis
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Elkhart
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Columbia
country: United States
state: Maryland
city: Salisbury
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Midland
country: United States
state: Michigan
city: Muskegon
country: United States
state: Michigan
city: Petoskey
country: United States
state: Michigan
city: Duluth
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Paramus
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Germantown
country: United States
state: Tennessee
city: Oak Ridge
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: New Westminster
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Saint John
country: Canada
state: New Brunswick
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: Brampton
country: Canada
state: Ontario
city: Burlington
country: Canada
state: Ontario
city: Cambridge
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Scarborough
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Fleurimont
country: Canada
state: Quebec
city: Gatineau
country: Canada
state: Quebec
city: Greenfield Park
country: Canada
state: Quebec
city: Lachine
country: Canada
state: Quebec
city: Laval
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montréal
country: Canada
state: Quebec
city: Montréal
country: Canada
state: Quebec
city: Saint Georges-de-beauce
country: Canada
state: Quebec
city: St-Charles-Borromée
country: Canada
state: Quebec
city: St-jerome
country: Canada
state: Quebec
city: St-Lambert
country: Canada
state: Quebec
city: Ste. Foy
country: Canada
state: Quebec
city: Sudbury
country: Canada
state: Quebec
city: Trois-Rivieres
country: Canada
state: Quebec
city: Val D'or
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Aachen
country: Germany
city: Berlin
country: Germany
city: Darmstadt
country: Germany
city: Essen
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Leipzig
country: Germany
city: Muenchen
country: Germany
city: München
country: Germany
city: Regensburg
country: Germany
city: Ulm
country: Germany
city: Elblag
country: Poland
city: Gdańsk
country: Poland
city: Krakow
country: Poland
city: Kraków
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Geneve
country: Switzerland
city: Kreuzlingen
country: Switzerland
city: Zürich
country: Switzerland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.