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| Sponsor: | Kumamoto University |
|---|---|
| Collaborators: |
The 4C trial bureau Japan Heart Foundation |
| Information provided by: | Kumamoto University |
| ClinicalTrials.gov Identifier: | NCT00139386 |
Purpose
Candesartan is effective in preventing cardiovascular events in patients without restenosis after coronary angioplasty. Therefore, the investigators hypothesized that candesartan after drug-eluting stent (DES) implantation was also effective in preventing cardiovascular events.
The purpose of this study is to investigate whether an angiotensin II receptor blocker, candesartan, is effective in reducing the incidence of cardiovascular events after drug-eluting stent implantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Coronary Artery Disease |
Drug: Candesartan Cilexetil (8-12 mg per day) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effects of Candesartan Cilexetil on Cardiovascular Events in Japanese Patients With Hypertension After Sirolimus- or Paclitaxel-Eluting Stents Implantation |
| Estimated Enrollment: | 2000 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | September 2007 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: 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 | Recruiting |
| Kumamoto, Japan, 860-8556 | |
| Contact: Tomohiro Sakamoto, MD, PhD +81-96-373-5175 tom@kumamoto-u.ac.jp | |
| Principal Investigator: Tomohiro Sakamoto, MD, PhD | |
| Study Chair: | Hisao Ogawa, MD, PhD | Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University |
More Information
| ClinicalTrials.gov Identifier: | NCT00139386 History of Changes |
| Other Study ID Numbers: | CVM-RCT-2005-01 |
| Study First Received: | August 29, 2005 |
| Last Updated: | March 27, 2006 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
Drug-eluting stent Candesartan Randomized control study Coronary Angioplasty |
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Hypertension Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Candesartan cilexetil Candesartan Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
