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

Condition(s) targeted: Hypertension; Coronary Artery Disease

Intervention: Candesartan Cilexetil (8-12 mg per day) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Kumamoto University

Official(s) and/or principal investigator(s):
Hisao Ogawa, MD, PhD, Study Chair, Affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

Overall contact:
Tomohiro Sakamoto, MD, PhD, Phone: +81-96-373-5175, Email: tom@kumamoto-u.ac.jp

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.

Official title: Effects of Candesartan Cilexetil on Cardiovascular Events in Japanese Patients With Hypertension After Sirolimus- or Paclitaxel-Eluting Stents Implantation

Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

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: The secondary endpoint is target lesion revascularization rate

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

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

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto 860-8556, Japan; Recruiting
Tomohiro Sakamoto, MD, PhD, Phone: +81-96-373-5175, Email: tom@kumamoto-u.ac.jp
Tomohiro Sakamoto, MD, PhD, Principal Investigator

Related 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.

Starting date: October 2005
Ending date: September 2007
Last updated: March 27, 2006