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

Not Applicable

Terminated

• Conditions: Acute Myocardial Infarction; Angina Pectoris; Acute Coronary Syndrome; Hypertension; Myocardial Ischemia
• Interventions: Drug: Micardis (Telmisartan); Drug: Blopress (Candesartan)

• Registration Number: NCT00863980
• Lead Sponsor: Kyoto Prefectural University of Medicine

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)

Study Timeline

• Study First Submitted: 2009-03-17
• Study First Submitted QC: 2009-03-17
• Study First Posted: 2009-03-18
• Study Start: 2009-04
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-01
• Last Update Posted: 2015-09-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1500

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telmisartan	Micardis (Telmisartan)	Treatment with Telmisartan
Candesartan	Blopress (Candesartan)	Treatment with Candesartan

Primary Outcome Measures

Name	Time	Method
New or recurrent acute myocardial infarction and angina pectoris	3 years

Secondary Outcome Measures

Name	Time	Method
All causes of mortality, cardiovascular death, new or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus	3 years

Trial Locations

Locations (32)

Akashi Municipal Hospital; 🇯🇵 Kobe, Japan

Kouseikai Takeda Hospital; 🇯🇵 Kyoto, Japan

Shakaihoken Kobe Central Hospital; 🇯🇵 Kobe, Japan

Social Insurance Kyoto Hospital; 🇯🇵 Kyoto, Japan

Kyoto Kojyo Hokenkai; 🇯🇵 Kyoto, Japan

Rakusai Simizu Hospital; 🇯🇵 Kyoto, Japan

Uji Hospital; 🇯🇵 Kyoto, Japan

Kyoto Yawata Hospital; 🇯🇵 Kyoto, Japan

Tanabe Central Hospital; 🇯🇵 Kyoto, Japan

Seizinkai Simizu Hospital; 🇯🇵 Kyoto, Japan

Saiseikai Kyoto Hospital; 🇯🇵 Kyoto, Japan

Public Yamasiro Hospital; 🇯🇵 Kyoto, Japan

Gakkentoshi Hospital; 🇯🇵 Kyoto, Japan

Omihachiman Community Medical Center; 🇯🇵 Shiga, Japan

Aijyukai Dohjin Hospital; 🇯🇵 Kyoto, Japan

Kyoto Second Red Cross Hospital; 🇯🇵 Kyoto, Japan

Kyoto Prefectural University of Medicine; 🇯🇵 Kyoto, Japan

Kyoto City Hospital; 🇯🇵 Kyoto, Japan

Kyoto First Red Cross Hospital; 🇯🇵 Kyoto, Japan

Aiseikai Yamashina Hospital; 🇯🇵 Kyoto, Japan

Fukuchiyama City Hospital; 🇯🇵 Kyoto, Japan

Ayabe City Hospital; 🇯🇵 Kyoto, Japan

Maizuru Kyosai Hospital; 🇯🇵 Kyoto, Japan

Public Nantan Hospital; 🇯🇵 Kyoto, Japan

Maizuru Red Cross Hospital; 🇯🇵 Kyoto, Japan

National Hospital Organization Maizuru Medical Center; 🇯🇵 Kyoto, Japan

Kyoto Prefectural Yosanoumi Hospital; 🇯🇵 Kyoto, Japan

Sakurakai Takahashi Hospital; 🇯🇵 Kyoto, Japan

Saiseikai Shiga Hospital; 🇯🇵 Shiga, Japan

Kumihama Hospital; 🇯🇵 Kyoto, Japan

Yuuseikai Midorigaoka Hospital; 🇯🇵 Osaka, Japan

Matsushita Memorial Hospital; 🇯🇵 Osaka, Japan