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

Condition(s) targeted: Acute Myocardial Infarction; Angina Pectoris; Myocardial Ischemia; Acute Coronary Syndrome; Hypertension

Intervention: Micardis (Telmisartan) (Drug); Blopress (Candesartan) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Kyoto Prefectural University of Medicine

Official(s) and/or principal investigator(s):
Hiroaki Matsubara, MD, PhD, Study Chair, Affiliation: Kyoto Prefectural University of Medicine

Overall contact:
Hiroaki Matsubara, MD, PhD, Phone: 81-75-251-5511, Email: matsubah@koto.kpu-m.ac.jp

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.

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

Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: New or recurrent acute myocardial infarction, angina pectoris, and asymptomatic myocardial ischemia

Secondary outcome: All causes of mortality, cardiovascular death, new or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus

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)

Minimum age: 30 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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

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

Hiroaki Matsubara, MD, PhD, Phone: 81-75-251-5511, Email: matsubah@koto.kpu-m.ac.jp

Akashi Municipal Hospital, Kobe 673-8501, Japan; Recruiting
Susumu Sasaki, Phone: 81-78-912-2323, Email: sasaki@koto.kpu-m.ac.jp

Shakaihoken Kobe Central Hospital, Kobe 651-1145, Japan; Recruiting
Toshiyuki Otomo, Phone: 81-78-594-2211, Email: kohbeb36@pmet.or.jp

Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan; Recruiting
Hiroyuki Yamada, MD, PhD, Phone: 81-75-251-5511, Email: hiyamada@koto.kpu-m.ac.jp
Hiroaki Matsubara, MD, PhD, Principal Investigator

Aijyukai Dohjin Hospital, Kyoto 602-0917, Japan; Not yet recruiting
Suetugu Inagaki, Phone: 81-75-431-3300, Email: ina2001@mbox.kyoto-inet.or.jp

Aiseikai Yamashina Hospital, Kyoto 607-8086, Japan; Not yet recruiting
Phone: 81-75-594-2323

Ayabe City Hospital, Kyoto 623-0011, Japan; Recruiting
Kouji Shiga, MD,PhD, Phone: 81-773-43-0123, Email: shiga.k@ayabe-hsp.or.jp

Uji Hospital, Kyoto 611-0011, Japan; Recruiting
Shohei Sawada, Phone: 81-774-32-6000, Email: sawada@koto.kpu-m.ac.jp

Gakkentoshi Hospital, Kyoto 619-0238, Japan; Recruiting
Ryuuta Sakai, Phone: 81-774-98-213, Email: r-sakai@iseikai.jp

Public Nantan Hospital, Kyoto 629-0197, Japan; Recruiting
Tetuya Tatsumi, Phone: 81-771-42-2510, Email: ttatsumi0221@yahoo.co.jp

Kyoto City Hospital, Kyoto 604-8845, Japan; Not yet recruiting
Phone: 81-75-311-5311

Kyoto First Red Cross Hospital, Kyoto 605-0981, Japan; Recruiting
Masayuki Hyogo, Phone: 81-75-561-1121, Email: masayuki-hyogo@kyoto1-jrc.org

Kyoto Second Red Cross Hospital, Kyoto 602-8026, Japan; Recruiting
Makoto Kitamura, Phone: 81-75-231-5171, Email: kitamuram@kyoto2.jrc.or.jp

Kyoto Yawata Hospital, Kyoto 614-8114, Japan; Recruiting
Keiko Iehara, Phone: 81-75-971-2001, Email: Keiko-i@hera.eonet.ne.jp

Kumihama Hospital, Kyoto 629-3403, Japan; Not yet recruiting
Seisuke Okuda, Phone: 81-772-82-1500

Kouseikai Takeda Hospital, Kyoto 600-8558, Japan; Recruiting
Noriyuki Kinoshita, Phone: 81-75-361-1351, Email: nkinoshi@pearl.ocn.ne.jp

Kyoto Kojyo Hokenkai, Kyoto 604-8472, Japan; Recruiting
Kazuo Takeda, Phone: 81-75-802-0131, Email: takeda@kyotokojyohokenkai.or.jp

Public Yamasiro Hospital, Kyoto 619-0214, Japan; Recruiting
Kiichiro Tomiyasu, Phone: 81-774-72-0235

Saiseikai Kyoto Hospital, Kyoto 617-0814, Japan; Recruiting
Yamahara, Phone: 81-75-955-0111

Sakurakai Takahashi Hospital, Kyoto 654-0026, Japan; Recruiting
Takahashi, Phone: 81-78-733-1136

Social Insurance Kyoto Hospital, Kyoto 603-8151, Japan; Not yet recruiting
Chizuru Yamada, Phone: 81-75-441-6101

National Hospital Organization Maizuru Medical Center, Kyoto 625-8502, Japan; Recruiting
Yoshiaki Harada, Phone: 81-773-62-2680, Email: yharada@eos.ocn.ne.jp

Tanabe Central Hospital, Kyoto 610-0334, Japan; Recruiting
Shigehiro Kusuoka, Phone: 81-774-63-1111, Email: kusu-oka@lime.ocn.ne.jp

Fukuchiyama City Hospital, Kyoto 620-8505, Japan; Recruiting
Manabu Nishio, Phone: 81-773-22-2101, Email: 7e5c33@bma.biglobe.ne.jp

Seizinkai Simizu Hospital, Kyoto 615-8237, Japan; Not yet recruiting
Yasushi Kubota, Phone: 81-75-381-5161

Maizuru Kyosai Hospital, Kyoto 625-8585, Japan; Not yet recruiting
Yoshihumi Okawa, Phone: 81-773-62-2510, Email: sunmoon91@gmail.com

Maizuru Red Cross Hospital, Kyoto 624-0906, Japan; Recruiting
Yoneyama, Phone: 81-773-75-4175

Kyoto Prefectural Yosanoumi Hospital, Kyoto 629-2261, Japan; Recruiting
Shinzo Kimura, Phone: 81-772-46-3371, Email: shinzo@koto.kpu-m.ac.jp

Rakusai Simizu Hospital, Kyoto 610-1106, Japan; Not yet recruiting
Teruyuki Yamamoto, Phone: 81-75-331-8778

Matsushita Memorial Hospital, Osaka 570-8540, Japan; Recruiting
Hiroki Sugihara, Phone: 81-6-6992-1231, Email: sugihara.hiroki001@jp.panasonic.com

Yuuseikai Midorigaoka Hospital, Osaka 569-1121, Japan; Not yet recruiting
Masaya Miyagawa, Phone: 81-72-681-5717, Email: kfa06774@nifty.com

Omihachiman Community Medical Center, Shiga 523-0892, Japan; Recruiting
Kan Zen, Phone: 81-748-33-3151, Email: k-zen@hera.eonet.ne.jp

Saiseikai Shiga Hospital, Shiga 520-3046, Japan; Recruiting
Nakahara, Phone: 81-77-552-1221, Email: nakahara-yamh@pop21.odn.ne.jp

Starting date: April 2009
Last updated: May 26, 2010