NCT00139386

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,119

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 18, 2013

Status Verified

April 1, 2013

Enrollment Period

3.5 years

First QC Date

August 29, 2005

Last Update Submit

April 17, 2013

Conditions

HypertensionCoronary Artery Disease

Keywords

Drug-eluting stentCandesartanRandomized control studyCoronary Angioplasty

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is a composite of: 1)any cause mortality and 2)cardiovascular events (non-fatal MI, drug-resistant AP required hospital admission, heart failure required hospital admission and stroke)

    3 years

Secondary Outcomes (7)

  • Target lesion revascularization

    3 years

  • Binary restenosis

    3 years

  • Newly onset diabetes

    3 years

  • Newly onset atrial fibrillation

    3 yeard

  • Each of the primary endpoint events

    3 years

  • +2 more secondary outcomes

Study Arms (2)

Candesratan

ACTIVE COMPARATOR
Drug: Candesartan

Non-candesartan

NO INTERVENTION

Interventions

CandesartanDRUG

Candesartan Cilexetil (4-12 mg per day)

Also known as: Blopress, 4C
Candesratan

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A. Patients with hypertension, systolic blood pressure (SBP) = or \> 140 and/or diastolic blood pressure (DBP) = or \> 90
  • B. Patients with symptomatic heart failure lasting at least for 4 weeks (NYHA class = or \> II), or those need continuous use of diuretics
  • C. Patients underwent coronary angioplasty with drug-eluting stents
  • Eligible patients are those who meet (A or B) and C.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kumamoto, 860-8556, Japan

Location

Related Publications (2)

  • 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. doi: 10.1016/S0002-8703(03)00443-5.

    PMID: 14661009BACKGROUND

  • Sakamoto T, Ogawa H, Nakao K, Hokimoto S, Tsujita K, Koide S, Yamamoto N, Shimomura H, Matsumura T, Oshima S, Kikuta K, Oka H, Kimura K, Matsui K; 4C (Candesartan for Prevention of Cardiovascular Events after CYPHER or TAXUS Coronary Stenting) study investigators. Impact of candesartan on cardiovascular events after drug-eluting stent implantation in patients with coronary artery disease: The 4C trial. J Cardiol. 2016 Apr;67(4):371-7. doi: 10.1016/j.jjcc.2015.06.009. Epub 2015 Aug 4.

    PMID: 26254019DERIVED

Related Links

MeSH Terms

Conditions

HypertensionCoronary Artery Disease

Interventions

candesartancandesartan cilexetil

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Hisao Ogawa, MD, PhD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

October 1, 2005

Primary Completion

April 1, 2009

Study Completion

April 1, 2012

Last Updated

April 18, 2013

Record last verified: 2013-04

Locations

JP(1)