ILLUMINATE Trial
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ILLUMINATE Trial On the Web |
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Objective
Raising HDL levels by a combination of torcetrapib, a CETP inhibitor, and atorvastatin, an HGM-CoA reductase inhibitor.
Dates
Start Date
August 23, 2004
End Date
Premature Termination on December 2, 2006. Data collection continued till July 15, 2007.
Methods
- Phase III trial
- Prospective, randomized, multicenter, double-blind clinical trial that recuited 15,067 patients.
- Inclusion criteria: Patients aged 45-75 years who have a history of cardiovascular disease 30 days to 5 years before screening; patients who have type 2 diabetes mellitus that meet criteria of the American Diabetes Association or receive anti-diabetic agents, even without previous cardiovascular disease.
- Exclusion criteria: Unstable medical condition, life expectancy less than 5 years, LDL-C levels < 100 mg/dL, those not receiving anti-lipidemic medications, if LDL-C target level not achieved at termination of run-in period, and those who have cardiovascular event during run-in period or uncontrolled hypertension: SBP>140 mmHg or DBP>90 mmHg,
- Run-in period: 4-10 weeks
- Cardiovascular disease was defined as myocardial infarction, stroke, acute coronary syndrome, unstable angina, peripheral vascular disease, and cardiac revascularization.
- Two arms of the study: Atorvastatin alone or atorvastatin plus torcetrapib 60 mg. Dosage of atorvastatin was determined while achieving of target LDL-C levels during run-in period and can be changed during the study period according to LDL-C levels.
- Primary Outcome was defined as the time to first “cardiovascular event”.
- “Cardiovascular event” defined as death from coronary artery disease, nonfatal myocardial infarction, stroke, or hospitalization for unstable angina. Procedure-related deaths and events were excluded.
- Secondary outcome: time to the first occurrence of a primary outcome. Time to death regardless of the etiology, change from baseline LDL and HDL levels.
- Outcomes based on 1,3,6,9, and 12 months scheduled visits.