Clinical trial NCT00863980: Effects of Telmisartan on Ischemic Cardiovascular Events in High-risk Hypertensive Patients
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Myocardial Infarction
Angina Pectoris
Myocardial Ischemia
Acute Coronary Syndrome
Hypertension
Keywords: angiotensin
receptor
vulnerable plaque
coronary artery
Lead sponsor: Kyoto Prefectural University of Medicine
Sponsor class: OTHER
First posted: 2009-03-18
Enrollment: 1500
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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)

Eligibility 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

Primary outcomes:
measure: New or recurrent acute myocardial infarction and angina pectoris
timeFrame: 3 years
Secondary outcomes:
measure: All causes of mortality, cardiovascular death, new or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus
timeFrame: 3 years
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Shakaihoken Kobe Central Hospital
city: Kobe
country: Japan
facility: Akashi Municipal Hospital
city: Kyoto
country: Japan
facility: Kouseikai Takeda Hospital
city: Kyoto
country: Japan
facility: Aijyukai Dohjin Hospital
city: Kyoto
country: Japan
facility: Kyoto Second Red Cross Hospital
city: Kyoto
country: Japan
facility: Kyoto Prefectural University of Medicine
city: Kyoto
country: Japan
facility: Social Insurance Kyoto Hospital
city: Kyoto
country: Japan
facility: Kyoto Kojyo Hokenkai
city: Kyoto
country: Japan
facility: Kyoto City Hospital
city: Kyoto
country: Japan
facility: Kyoto First Red Cross Hospital
city: Kyoto
country: Japan
facility: Aiseikai Yamashina Hospital
city: Kyoto
country: Japan
facility: Tanabe Central Hospital
city: Kyoto
country: Japan
facility: Rakusai Simizu Hospital
city: Kyoto
country: Japan
facility: Uji Hospital
city: Kyoto
country: Japan
facility: Kyoto Yawata Hospital
city: Kyoto
country: Japan
facility: Seizinkai Simizu Hospital
city: Kyoto
country: Japan
facility: Saiseikai Kyoto Hospital
city: Kyoto
country: Japan
facility: Public Yamasiro Hospital
city: Kyoto
country: Japan
facility: Gakkentoshi Hospital
city: Kyoto
country: Japan
facility: Fukuchiyama City Hospital
city: Kyoto
country: Japan
facility: Ayabe City Hospital
city: Kyoto
country: Japan
facility: Maizuru Red Cross Hospital
city: Kyoto
country: Japan
facility: National Hospital Organization Maizuru Medical Center
city: Kyoto
country: Japan
facility: Maizuru Kyosai Hospital
city: Kyoto
country: Japan
facility: Public Nantan Hospital
city: Kyoto
country: Japan
facility: Kyoto Prefectural Yosanoumi Hospital
city: Kyoto
country: Japan
facility: Kumihama Hospital
city: Kyoto
country: Japan
facility: Sakurakai Takahashi Hospital
city: Osaka
country: Japan
facility: Yuuseikai Midorigaoka Hospital
city: Osaka
country: Japan
facility: Matsushita Memorial Hospital
city: Shiga
country: Japan
facility: Saiseikai Shiga Hospital
city: Shiga
country: Japan
facility: Omihachiman Community Medical Center
Study officials:
affiliation: Kyoto Prefectural University of Medicine
name: Hiroaki Matsubara, MD, PhD
role: STUDY_CHAIR
References: