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

Condition(s) targeted: Acute Myocardial Infarction; Angina Pectoris; Myocardial Ischemia; Acute Coronary Syndrome; Hypertension

Intervention: Micardis (Telmisartan) (Drug); Blopress (Candesartan) (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Kyoto Prefectural University of Medicine

Official(s) and/or principal investigator(s):
Hiroaki Matsubara, MD, PhD, Study Chair, Affiliation: Kyoto Prefectural University of Medicine

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: New or recurrent acute myocardial infarction and angina pectoris

Secondary outcome: All causes of mortality, cardiovascular death, new or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus

Detailed description: 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)

Minimum age: 30 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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

Akashi Municipal Hospital, Kobe 673-8501, Japan

Shakaihoken Kobe Central Hospital, Kobe 651-1145, Japan

Aijyukai Dohjin Hospital, Kyoto 602-0917, Japan

Aiseikai Yamashina Hospital, Kyoto 607-8086, Japan

Ayabe City Hospital, Kyoto 623-0011, Japan

Fukuchiyama City Hospital, Kyoto 620-8505, Japan

Gakkentoshi Hospital, Kyoto 619-0238, Japan

Kouseikai Takeda Hospital, Kyoto 600-8558, Japan

Kumihama Hospital, Kyoto 629-3403, Japan

Kyoto City Hospital, Kyoto 604-8845, Japan

Kyoto First Red Cross Hospital, Kyoto 605-0981, Japan

Kyoto Kojyo Hokenkai, Kyoto 604-8472, Japan

Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan

Kyoto Prefectural Yosanoumi Hospital, Kyoto 629-2261, Japan

Kyoto Second Red Cross Hospital, Kyoto 602-8026, Japan

Kyoto Yawata Hospital, Kyoto 614-8114, Japan

Maizuru Kyosai Hospital, Kyoto 625-8585, Japan

Maizuru Red Cross Hospital, Kyoto 624-0906, Japan

National Hospital Organization Maizuru Medical Center, Kyoto 625-8502, Japan

Public Nantan Hospital, Kyoto 629-0197, Japan

Public Yamasiro Hospital, Kyoto 619-0214, Japan

Rakusai Simizu Hospital, Kyoto 610-1106, Japan

Saiseikai Kyoto Hospital, Kyoto 617-0814, Japan

Sakurakai Takahashi Hospital, Kyoto 654-0026, Japan

Seizinkai Simizu Hospital, Kyoto 615-8237, Japan

Social Insurance Kyoto Hospital, Kyoto 603-8151, Japan

Tanabe Central Hospital, Kyoto 610-0334, Japan

Uji Hospital, Kyoto 611-0011, Japan

Matsushita Memorial Hospital, Osaka 570-8540, Japan

Yuuseikai Midorigaoka Hospital, Osaka 569-1121, Japan

Omihachiman Community Medical Center, Shiga 523-0892, Japan

Saiseikai Shiga Hospital, Shiga 520-3046, Japan

Starting date: April 2009
Last updated: June 22, 2011