Effects of Telmisartan on Ischemic Cardiovascular Events in High-risk Hypertensive Patients

Effects of Telmisartan Compared With Candesartan on Ischemic Cardiovascular Events in High-risk Hypertensive Patients: a Multi-center, Prospective, Randomized, Open-labeled, Blinded Endpoints Trial

This study is aimed to investigate whether treatment with Telmisartan is more effective than Candesartan in reducing the ischemic cardiovascular events in high-risk patients with cardiovascular disease.

This study is aimed to investigate whether treatment with Telmisartan is more effective than Candesartan in reducing the ischemic cardiovascular events in high-risk patients with cardiovascular disease.

Study design: PROBE(Prospective, Randomized, Open-labeled Blind Endpoints)

Inclusion Criteria:

The inclusion criteria are set by at least one of the three following risk factors:

1. Coronary artery disease documented by at least one of the following:

   • Myocardial infarction at least 12 months before enrollment and not planned for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
   • Angina pectoris or asymptomatic myocardial ischemia undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at least 12 months before enrollment and not planned for further percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)

2. Peripheral arterial disease undergoing percutaneous transluminal angioplasty (PTA) or peripheral artery bypass grafting at least 6 months before enrollment

3. Symptomatic cerebral infarction or cerebral hemorrhage at least 6 months before enrollment

Exclusion Criteria:

The exclusion criteria are set as follows:

1. History of worsening of heart failure within the preceding 6 months
2. Planned elective percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the anteceding 3 months
3. History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the preceding 12 months
4. History of percutaneous hind limb angioplasty (PTA) or bypass grafting within the preceding 6 months
5. History of cerebral infarction, cerebral hemorrhage within the past 6 months
6. Congenital heart disease
7. Uncontrolled hypertension on treatment (eg, BP>180/110 mmHg)
8. Pregnant women or women of childbearing potential
9. Hepatic dysfunction (AST or ALT >100IU/L)
10. Renal impairment (serum creatinine level >2.0 mg per 100 ml)
11. Known hypersensitivity or intolerance to ARB