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:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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 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, angina pectoris, and asymptomatic myocardial ischemia [ 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
Telmisartan: Experimental Treatment with Telmisartan	Drug: Micardis (Telmisartan) 40-80 mg/day oral administration
Candesartan: Active Comparator Treatment with Candesartan	Drug: Blopress (Candesartan) 8-12 mg/day oral administration

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

Contacts

Contact: Hiroaki Matsubara, MD, PhD

81-75-251-5511

matsubah@koto.kpu-m.ac.jp

Locations

Japan
Akashi Municipal Hospital	Recruiting
Kobe, Japan, 673-8501
Contact: Susumu Sasaki 81-78-912-2323 sasaki@koto.kpu-m.ac.jp
Shakaihoken Kobe Central Hospital	Recruiting
Kobe, Japan, 651-1145
Contact: Toshiyuki Otomo 81-78-594-2211 kohbeb36@pmet.or.jp
Kyoto Prefectural University of Medicine	Recruiting
Kyoto, Japan, 602-8566
Contact: Hiroyuki Yamada, MD, PhD 81-75-251-5511 hiyamada@koto.kpu-m.ac.jp
Principal Investigator: Hiroaki Matsubara, MD, PhD
Aijyukai Dohjin Hospital	Not yet recruiting
Kyoto, Japan, 602-0917
Contact: Suetugu Inagaki 81-75-431-3300 ina2001@mbox.kyoto-inet.or.jp
Aiseikai Yamashina Hospital	Not yet recruiting
Kyoto, Japan, 607-8086
Contact 81-75-594-2323
Ayabe City Hospital	Recruiting
Kyoto, Japan, 623-0011
Contact: Kouji Shiga, MD,PhD 81-773-43-0123 shiga.k@ayabe-hsp.or.jp
Uji Hospital	Recruiting
Kyoto, Japan, 611-0011
Contact: Shohei Sawada 81-774-32-6000 sawada@koto.kpu-m.ac.jp
Gakkentoshi Hospital	Recruiting
Kyoto, Japan, 619-0238
Contact: Ryuuta Sakai 81-774-98-213 r-sakai@iseikai.jp
Kyoto Kojyo Hokenkai	Recruiting
Kyoto, Japan, 604-8472
Contact: Kazuo Takeda 81-75-802-0131 takeda@kyotokojyohokenkai.or.jp
Kyoto City Hospital	Not yet recruiting
Kyoto, Japan, 604-8845
Contact 81-75-311-5311
Kyoto First Red Cross Hospital	Recruiting
Kyoto, Japan, 605-0981
Contact: Masayuki Hyogo 81-75-561-1121 masayuki-hyogo@kyoto1-jrc.org
Kyoto Second Red Cross Hospital	Recruiting
Kyoto, Japan, 602-8026
Contact: Makoto Kitamura 81-75-231-5171 kitamuram@kyoto2.jrc.or.jp
Kyoto Yawata Hospital	Recruiting
Kyoto, Japan, 614-8114
Contact: Keiko Iehara 81-75-971-2001 Keiko-i@hera.eonet.ne.jp
Kumihama Hospital	Not yet recruiting
Kyoto, Japan, 629-3403
Contact: Seisuke Okuda 81-772-82-1500
Kouseikai Takeda Hospital	Recruiting
Kyoto, Japan, 600-8558
Contact: Noriyuki Kinoshita 81-75-361-1351 nkinoshi@pearl.ocn.ne.jp
Public Nantan Hospital	Recruiting
Kyoto, Japan, 629-0197
Contact: Tetuya Tatsumi 81-771-42-2510 ttatsumi0221@yahoo.co.jp
Saiseikai Shiga Hospital	Recruiting
Shiga, Japan, 520-3046
Contact: Nakahara 81-77-552-1221 nakahara-yamh@pop21.odn.ne.jp
Saiseikai Kyoto Hospital	Recruiting
Kyoto, Japan, 617-0814
Contact: Yamahara 81-75-955-0111
Sakurakai Takahashi Hospital	Recruiting
Kyoto, Japan, 654-0026
Contact: Takahashi 81-78-733-1136
Social Insurance Kyoto Hospital	Not yet recruiting
Kyoto, Japan, 603-8151
Contact: Chizuru Yamada 81-75-441-6101
Seizinkai Simizu Hospital	Not yet recruiting
Kyoto, Japan, 615-8237
Contact: Yasushi Kubota 81-75-381-5161
Tanabe Central Hospital	Recruiting
Kyoto, Japan, 610-0334
Contact: Shigehiro Kusuoka 81-774-63-1111 kusu-oka@lime.ocn.ne.jp
Fukuchiyama City Hospital	Recruiting
Kyoto, Japan, 620-8505
Contact: Manabu Nishio 81-773-22-2101 7e5c33@bma.biglobe.ne.jp
National Hospital Organization Maizuru Medical Center	Recruiting
Kyoto, Japan, 625-8502
Contact: Yoshiaki Harada 81-773-62-2680 yharada@eos.ocn.ne.jp
Maizuru Kyosai Hospital	Not yet recruiting
Kyoto, Japan, 625-8585
Contact: Yoshihumi Okawa 81-773-62-2510 sunmoon91@gmail.com
Maizuru Red Cross Hospital	Recruiting
Kyoto, Japan, 624-0906
Contact: Yoneyama 81-773-75-4175
Kyoto Prefectural Yosanoumi Hospital	Recruiting
Kyoto, Japan, 629-2261
Contact: Shinzo Kimura 81-772-46-3371 shinzo@koto.kpu-m.ac.jp
Rakusai Simizu Hospital	Not yet recruiting
Kyoto, Japan, 610-1106
Contact: Teruyuki Yamamoto 81-75-331-8778
Matsushita Memorial Hospital	Recruiting
Osaka, Japan, 570-8540
Contact: Hiroki Sugihara 81-6-6992-1231 sugihara.hiroki001@jp.panasonic.com
Yuuseikai Midorigaoka Hospital	Not yet recruiting
Osaka, Japan, 569-1121
Contact: Masaya Miyagawa 81-72-681-5717 kfa06774@nifty.com
Omihachiman Community Medical Center	Recruiting
Shiga, Japan, 523-0892
Contact: Kan Zen 81-748-33-3151 k-zen@hera.eonet.ne.jp
Public Yamasiro Hospital	Recruiting
Kyoto, Japan, 619-0214
Contact: Kiichiro Tomiyasu 81-774-72-0235

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:	Kyoto Prefectural University of Medicine ( Hiroaki Matsubara )
Study ID Numbers:	C-486, UMIN000001762
Study First Received:	March 17, 2009
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00863980 History of Changes
Health Authority:	Japan: Institutional Review Board

Keywords provided by Kyoto Prefectural University of Medicine:

angiotensin
receptor
vulnerable plaque
coronary artery

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Angina Pectoris
Pain
Candesartan cilexetil
Signs and Symptoms
Necrosis
Pathologic Processes
Syndrome
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Myocardial Infarction
Heart Diseases

Disease
Vascular Diseases
Enzyme Inhibitors
Ischemia
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Chest Pain
Angiotensin II Type 1 Receptor Blockers
Acute Coronary Syndrome
Candesartan
Infarction
Hypertension

ClinicalTrials.gov processed this record on February 09, 2010