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Trial Summaries

TRANSCEND - Prevention of Cardiovascular Events in Patients Intolerant to ACE-I


TRANSCEND: Telmisartan Randomized AssessmeNt Study in aCE iNtolerant Subjects with Cardiovascular Disease Trial

Rationale:
Angiotensin II (A-II) is a potent vasoconstrictor that can cause myocardial hypertrophy and vascular pathology. Angiotensin converting enzyme inhibitors (ACE-I) have been shown to prevent death, recurrent myocardial infarction, and heart failure in patients with left ventricular dysfunction after myocardial infarction. Recently, the HOPE trial showed that ramipril, a tissue-specific ACE-I, had a vascular protective effect. Despite their proven benefit ACE-I have limitations. About 20% of patients exposed to ACE-I have intolerable adverse effects that lead to drug discontinuation and ACE-I do not completely block the generation of A-II. More recently, angiotensin receptor blockers (ARB) have been developed and shown to be effective for treatment of hypertension and have anti-inflammatory properties, but have not yet been adequately evaluated clinically for anti-atherogenic or vascular protective effects.

Purpose:
The primary goal of TRANSCEND is to determine if telmisartan, an ARB, is superior to placebo for preventing cardiovascular events. Secondary goals are to determine whether telmisartan is better than placebo for preventing heart failure, diabetes, cognitive decline, and atrial fibrillation.

Study Participants:
Men and women over the age of 55 years with a high risk of cardiovascular events, patients with coronary or cerebrovascular atherosclerosis, peripheral vascular disease, or diabetes and who are intolerant to ACE-I.

Study Design:
TRANSCEND is a multicenter, randomized, double-blind trial that will be conducted in approximately 40 countries and 800 clinical centers (125 in the United States of American). It is a companion trial to ONTARGET for those patients who are excluded from ONTARGET because they have ACE-I intolerance. Approximately 5,000 patients will be randomized to either telmisartan, or placebo. Patients will be recruited over a 25-month period and followed 3.5 to 5.5 years for the composite primary endpoint of cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure. TRANSCEND started recruiting in the Clinical Trials Network in January 2002.

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