Status:
TERMINATED
Effects of Telmisartan on Ischemic Cardiovascular Events in High-risk Hypertensive Patients
Lead Sponsor:
Kyoto Prefectural University of Medicine
Conditions:
Acute Myocardial Infarction
Angina Pectoris
Eligibility:
All Genders
30-85 years
Phase:
NA
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 diseas...
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 diseas...
Eligibility Criteria
Inclusion
- The inclusion criteria are set by at least one of the three following risk factors:
- 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)
- Peripheral arterial disease undergoing percutaneous transluminal angioplasty (PTA) or peripheral artery bypass grafting at least 6 months before enrollment
- Symptomatic cerebral infarction or cerebral hemorrhage at least 6 months before enrollment
Exclusion
- The exclusion criteria are set as follows:
- History of worsening of heart failure within the preceding 6 months
- Planned elective percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the anteceding 3 months
- History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the preceding 12 months
- History of percutaneous hind limb angioplasty (PTA) or bypass grafting within the preceding 6 months
- History of cerebral infarction, cerebral hemorrhage within the past 6 months
- Congenital heart disease
- Uncontrolled hypertension on treatment (eg, BP\>180/110 mmHg)
- Pregnant women or women of childbearing potential
- Hepatic dysfunction (AST or ALT \>100IU/L)
- Renal impairment (serum creatinine level \>2.0 mg per 100 ml)
- Known hypersensitivity or intolerance to ARB
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT00863980
Start Date
April 1 2009
End Date
July 1 2013
Last Update
September 3 2015
Active Locations (32)
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1
Shakaihoken Kobe Central Hospital
Kobe, Kobe, Japan, 651-1145
2
Akashi Municipal Hospital
Kobe, Kobe, Japan, 673-8501
3
Kouseikai Takeda Hospital
Kyoto, Kyoto, Japan, 600-8558
4
Aijyukai Dohjin Hospital
Kyoto, Kyoto, Japan, 602-0917