Candesartan is effective to prevent cardiovascular events in patients without restenosis after coronary angioplasty. Therefore, we hypothesized that candesartan after DES implantation was also effective to prevent cardiovascular events.

The purpose of this study is to investigate if an angiotensin II receptor blocker candesartan is effective to reduce the incidence of cardiovascular events after drug-eluting stents implantation.

Condition	Intervention	Phase
Hypertension Coronary Artery Disease Coronary Angioplasty	Drug: Candesartan Cilexetil 8-12 mg per day	Phase IV

Further Study Details: 

Primary Outcomes: The primary endpoint is a composite of; - any cause mortality,; - sudden death,; - cardiovascular death,; - nonfatal myocardial infarction,; - recurrent symptomatic myocardial ischemia,; - congestive heart failure,; - stroke
Secondary Outcomes: The secondary endpoint is target lesion revascularization rate.
Expected Total Enrollment:  2000

It was reported that low-dose angiotensin II receptor blocker candesartan was effective to prevent cardiovascular events in patients with coronary artery disease treated with coronary angioplasty (Am Heart J 146:E20, 2003). In this study, patients without significant coronary stenosis on follow-up angiography 6 months after intervention were randomly assigned into a candesartan group ( baseline treatment plus candesartan 4 mg/d) or a control group (baseline treatment alone). It is well known that patients treated with drug-eluting stents (DES) have lower restenosis rate as compared with those with bare metal stents. Therefore, we hypothesized that candesartan started immediately after DES implantation was effective to prevent cardiovascular events.

The primary endpoint is a composite of any cause mortality, sudden death, cardiovascular death, nonfatal myocardial infarction, recurrent symptomatic myocardial ischemia, congestive heart failure, and stroke. The secondary endpoint is target lesion revascularization rate.

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients with hypertension, SBP=or>140 and/or DBP=or>90
• Patients underwent coronary angioplasty with drug-eluting stents

Exclusion Criteria:

• Severe renal or hepatic disease
• Candidates for coronary artery bypass grafting (CABG)
• Within 3 months after CABG
• Allergic history against candesartan
• Pregnant women

Please refer to this study by ClinicalTrials.gov identifier  NCT00139386

Tomohiro Sakamoto, MD, PhD      +81-96-373-5175    tom@kumamoto-u.ac.jp

Japan
      Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto,  860-8556,  Japan

Study chairs or principal investigators

Hisao Ogawa, MD, PhD,  Study Chair,  Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University   

Study ID Numbers:  CVM-RCT-2005-01
Last Updated:  August 30, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00139386
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-06