Candesartan for Prevention of Cardiovascular Events After Cypher or Taxus Coronary Stenting (4C) Trial
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| ClinicalTrials.gov Identifier: NCT00139386 |
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Recruitment Status :
Completed
First Posted : August 31, 2005
Last Update Posted : April 18, 2013
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypertension Coronary Artery Disease | Drug: Candesartan | Phase 4 |
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 death and cardiovascular events (nonfatal myocardial infarction, recurrent symptomatic myocardial ischemia, congestive heart failure, and stroke). The secondary endpoints are target lesion revascularization, binary restenosis, newly onset diabetes and newly onset of atrial fibrillation.
Patient population which needs to prove the hypothesis is estimates to be 1,130 cases in total (565 cases in each group). We set the parameters which are needed to calculate the number of study patients as follows; a drop out rate 10%, an event rate of the primary end point for 3 years 20%, a risk reduction rate brought by candesartan 25%, a statistical power 90% and a two-sided significance level 0.05. We assumed the event rate from the study which was conducted to prove the effects of statins after PCI in Japan named MUSASHI-PCI. Also the risk reduction rate from two major RCTs of candesartan conducted in Japan named the Ogaki and HIJ-CREATE studies. In the Ogaki study, the risk reduction rate by candesartan was 52%. However, stents used in the study were only BMS after surviving restenosis. The risk reduction of the present study will be lower because of the higher onset rate of stent thrombosis in regard to DES. Furthermore, the risk reduction rate of candesartan for Japanese was 11% reported in HIJ-CREATE. The ACE-I usage rate was almost 70% in the control subjects of HIJ-CREATE. In the present study, ACE-I will be administered less frequently as low as 30%. Therefore, assumed risk reduction rate by candesartan in the present study could be higher. Considering all the various factors together, a reasonable risk reduction rate could be 25%.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1119 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | October 2005 |
| Actual Primary Completion Date : | April 2009 |
| Actual Study Completion Date : | April 2012 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Candesratan |
Drug: Candesartan
Candesartan Cilexetil (4-12 mg per day)
Other Names:
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| No Intervention: Non-candesartan |
- 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) [ Time Frame: 3 years ]
- Target lesion revascularization [ Time Frame: 3 years ]
- Binary restenosis [ Time Frame: 3 years ]
- Newly onset diabetes [ Time Frame: 3 years ]
- Newly onset atrial fibrillation [ Time Frame: 3 yeard ]
- Each of the primary endpoint events [ Time Frame: 3 years ]All cause of death, cardiovascular death, non-fatal myocardial infarction, unstable angina required admission, heart failure required admission and stroke
- Major adverse cardiac-related events [ Time Frame: 3 years ]A composite of cardiovascular death, non-fatal myocardial infarction, unstable angina required admission and heart failure required admission
- Major cardiac-related events [ Time Frame: 3 years ]A composite of non-fatal myocardial infarction, unstable angina required admission and heart failure required admission
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139386
| Japan | |
| Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University | |
| Kumamoto, Japan, 860-8556 | |
| Study Chair: | Hisao Ogawa, MD, PhD | Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hisao Ogawa, MD, PhD, Kumamoto University |
| ClinicalTrials.gov Identifier: | NCT00139386 History of Changes |
| Other Study ID Numbers: |
CVM-RCT-2005-01 |
| First Posted: | August 31, 2005 Key Record Dates |
| Last Update Posted: | April 18, 2013 |
| Last Verified: | April 2013 |
Keywords provided by Hisao Ogawa, Kumamoto University:
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Drug-eluting stent Candesartan Randomized control study Coronary Angioplasty |
Additional relevant MeSH terms:
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Hypertension Coronary Artery Disease Myocardial Ischemia Coronary Disease Vascular Diseases Cardiovascular Diseases Heart Diseases Arteriosclerosis |
Arterial Occlusive Diseases Candesartan Candesartan cilexetil Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |