Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139386
Status:
COMPLETED
Last Update Posted:
2013-04-18
First Post:
2005-08-29
Brief Title:
Candesartan for Prevention of Cardiovascular Events After Cypher or Taxus Coronary Stenting 4C Trial
Sponsor:
Kumamoto University
Organization:
Kumamoto University
Study Overview
Official Title:
Effects of Candesartan Cilexetil on Cardiovascular Events in Japanese Patients With Hypertension After Sirolimus- or Paclitaxel-Eluting Stents Implantation
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 146E20 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 mgd 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 1130 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 005 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
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 1130 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 005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None