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

Study Overview
=================
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)

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

Conditions
-----------------
Acute Myocardial Infarction, Angina Pectoris, Myocardial Ischemia, Acute Coronary Syndrome, Hypertension

Intervention / Treatment
-----------------
* Drug: Micardis (Telmisartan)
* Drug: Blopress (Candesartan)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan<br>Treatment with Telmisartan | Drug: Micardis (Telmisartan)<br>* 40-80 mg/day oral administration<br>* Other names: Micardis Tablets 40mg;|
| Active Comparator: Candesartan<br>Treatment with Candesartan | Drug: Blopress (Candesartan)<br>* 8-12 mg/day oral administration<br>* Other names: Blopless Tablets;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New or recurrent acute myocardial infarction and angina pectoris |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All causes of mortality, cardiovascular death, new or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
angiotensin, receptor, vulnerable plaque, coronary artery