Candesartan for Prevention of Cardiovascular Events After Cypher or Taxus Coronary Stenting (4C) Trial - Full Text View

Sponsors and Collaborators:	Kumamoto University 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

MedlinePlus related topics: Angioplasty Coronary Artery Disease High Blood Pressure

Drug Information available for: CV 11974 Candesartan cilexetil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of Candesartan Cilexetil on Cardiovascular Events in Japanese Patients With Hypertension After Sirolimus- or Paclitaxel-Eluting Stents Implantation

Further study details as provided by Kumamoto University:

Primary Outcome Measures:

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 Outcome Measures:

The secondary endpoint is target lesion revascularization rate

Estimated Enrollment:	2000
Study Start Date:	October 2005
Estimated Study Completion Date:	September 2007

Detailed Description:

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

Criteria

Inclusion Criteria:

Patients with hypertension, systolic blood pressure (SBP) = or > 140 and/or diastolic blood pressure (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 to candesartan
Pregnant women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139386

Contacts

Contact: Tomohiro Sakamoto, MD, PhD

+81-96-373-5175

tom@kumamoto-u.ac.jp

Locations

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

Sponsors and Collaborators

Kumamoto University

The 4C trial bureau

Japan Heart Foundation

Investigators

Study Chair:

Hisao Ogawa, MD, PhD

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

More Information

Publications:

Kondo J, Sone T, Tsuboi H, Mukawa H, Morishima I, Uesugi M, Kono T, Kosaka T, Yoshida T, Numaguchi Y, Matsui H, Murohara T, Okumura K. Effects of low-dose angiotensin II receptor blocker candesartan on cardiovascular events in patients with coronary artery disease. Am Heart J. 2003 Dec;146(6):E20.

Study ID Numbers:	CVM-RCT-2005-01
Study First Received:	August 29, 2005
Last Updated:	March 27, 2006
ClinicalTrials.gov Identifier:	NCT00139386 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kumamoto University:

Drug-eluting stent
Candesartan
Randomized control study
Coronary Angioplasty

Study placed in the following topic categories:

Arterial Occlusive Diseases
Sirolimus
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Cardiovascular Agents
Ischemia
Arteriosclerosis
Angiotensin II

Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Coronary Disease
Candesartan cilexetil
Paclitaxel
Candesartan
Coronary Artery Disease
Hypertension

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Angiotensin II Type 1 Receptor Blockers
Coronary Disease
Candesartan cilexetil
Therapeutic Uses
Candesartan
Cardiovascular Diseases
Coronary Artery Disease
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009