Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT01069302
Status:
COMPLETED
Last Update Posted:
2016-01-11
First Post:
2010-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan
Sponsor:
Takeshi Morimoto
Organization:
Study Overview
Official Title:
Clopidogrel High Dose Evaluation for the Patient With Coronary Artery Disease in Japan
Status:
COMPLETED
Status Verified Date:
2016-01
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:
CHOICE
Brief Summary:
The purpose of this study is to evaluate the effect of high dose clopidogrel as the antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for percutaneous coronary intervention due to ischemic heart disease.
Detailed Description:
Dual antiplatelet therapy of aspirin and thienopyridine is used to prevent stent thrombosis after percutaneous coronary intervention (PCI). Clopidogrel is the most popular thienopyridine. Following the 300mg clopidogrel loading dose (LD) at first day, patients take 75mg maintenance dose (MD) to inhibit platelet aggregation after coronary stent implantation. 600mg high LD inhibit platelet aggregation more rapidly and strongly than standard LD and prevent thrombotic event around the PCI. Similarly high MD inhibit platelet aggregation more strongly. Interindividual variability of clopidogrel anti-platelet effect has been reported. In Japanese, there are many non or hyporesponders to clopidogrel compared to the Western population. The purpose of this study is to evaluate the effect of high dose clopidogrel as the antiplatelet therapy on inhibition of platelet aggregation in Japanese patients scheduled for PCI due to ischemic heart disease.
Study Oversight
Has Oversight DMC:
True
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?: