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

Sponsor:	Kyoto Prefectural University of Medicine
Information provided by:	Kyoto Prefectural University of Medicine
ClinicalTrials.gov Identifier:	NCT00863980

Purpose

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.

Condition	Intervention
Acute Myocardial Infarction Angina Pectoris Myocardial Ischemia Acute Coronary Syndrome Hypertension	Drug: Micardis (Telmisartan) Drug: Blopress (Candesartan)

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

Resource links provided by NLM:

MedlinePlus related topics: Angina Coronary Artery Disease Heart Attack High Blood Pressure

Drug Information available for: CV 11974 Telmisartan Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by Kyoto Prefectural University of Medicine:

Primary Outcome Measures:

New or recurrent acute myocardial infarction and angina pectoris [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

All causes of mortality, cardiovascular death, new or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1500
Study Start Date:	April 2009
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Telmisartan Treatment with Telmisartan	Drug: Micardis (Telmisartan) 40-80 mg/day oral administration Other Names: 21600AMZ00541000 Micardis Tablets 40mg
Active Comparator: Candesartan Treatment with Candesartan	Drug: Blopress (Candesartan) 8-12 mg/day oral administration Other Name: Blopless Tablets

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

Ages Eligible for Study:	30 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863980

Locations

Japan
Akashi Municipal Hospital
Kobe, Japan, 673-8501
Shakaihoken Kobe Central Hospital
Kobe, Japan, 651-1145
Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566
Aijyukai Dohjin Hospital
Kyoto, Japan, 602-0917
Aiseikai Yamashina Hospital
Kyoto, Japan, 607-8086
Ayabe City Hospital
Kyoto, Japan, 623-0011
Uji Hospital
Kyoto, Japan, 611-0011
Gakkentoshi Hospital
Kyoto, Japan, 619-0238
Kyoto Kojyo Hokenkai
Kyoto, Japan, 604-8472
Kyoto City Hospital
Kyoto, Japan, 604-8845
Kyoto First Red Cross Hospital
Kyoto, Japan, 605-0981
Kyoto Second Red Cross Hospital
Kyoto, Japan, 602-8026
Kyoto Yawata Hospital
Kyoto, Japan, 614-8114
Kumihama Hospital
Kyoto, Japan, 629-3403
Kouseikai Takeda Hospital
Kyoto, Japan, 600-8558
Public Nantan Hospital
Kyoto, Japan, 629-0197
Public Yamasiro Hospital
Kyoto, Japan, 619-0214
Saiseikai Kyoto Hospital
Kyoto, Japan, 617-0814
Sakurakai Takahashi Hospital
Kyoto, Japan, 654-0026
Social Insurance Kyoto Hospital
Kyoto, Japan, 603-8151
Seizinkai Simizu Hospital
Kyoto, Japan, 615-8237
Tanabe Central Hospital
Kyoto, Japan, 610-0334
Fukuchiyama City Hospital
Kyoto, Japan, 620-8505
National Hospital Organization Maizuru Medical Center
Kyoto, Japan, 625-8502
Maizuru Kyosai Hospital
Kyoto, Japan, 625-8585
Maizuru Red Cross Hospital
Kyoto, Japan, 624-0906
Kyoto Prefectural Yosanoumi Hospital
Kyoto, Japan, 629-2261
Rakusai Simizu Hospital
Kyoto, Japan, 610-1106
Matsushita Memorial Hospital
Osaka, Japan, 570-8540
Yuuseikai Midorigaoka Hospital
Osaka, Japan, 569-1121
Omihachiman Community Medical Center
Shiga, Japan, 523-0892
Saiseikai Shiga Hospital
Shiga, Japan, 520-3046

Sponsors and Collaborators

Kyoto Prefectural University of Medicine

Investigators

Study Chair:

Hiroaki Matsubara, MD, PhD

Kyoto Prefectural University of Medicine

More Information

No publications provided

Responsible Party:	Hiroaki Matsubara, Kyoto Prefectural University of Medicine
ClinicalTrials.gov Identifier:	NCT00863980 History of Changes
Other Study ID Numbers:	C-486, UMIN000001762
Study First Received:	March 17, 2009
Last Updated:	June 22, 2011
Health Authority:	Japan: Institutional Review Board

Keywords provided by Kyoto Prefectural University of Medicine:

angiotensin
receptor
vulnerable plaque
coronary artery

Additional relevant MeSH terms:

Angina Pectoris
Myocardial Ischemia
Coronary Artery Disease
Hypertension
Infarction
Ischemia
Myocardial Infarction
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Coronary Disease

Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Necrosis
Candesartan
Candesartan cilexetil
Telmisartan
Benzoates
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012