Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140465
Status:
COMPLETED
Last Update Posted:
2007-11-14
First Post:
2005-08-31
Brief Title:
75 or 150 mg Clopidogrel Maintenance Doses Following PCI ISAR-CHOICE-2
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Deutsches Herzzentrum Muenchen
Study Overview
Official Title:
A Double-Blind Randomized Comparison Between Two Different Clopidogrel Maintenance Doses After Percutaneous Coronary Intervention ISAR-CHOICE-2
Status:
COMPLETED
Status Verified Date:
2007-11
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:
The purpose of the study is to test whether an increase of the maintenance dose of clopidogrel from 75 to 150 mg per day results in an additional suppression of ADP-induced platelet aggregation
Detailed Description:
In patients treated with coronary stents clopidogrel therapy is usually initiated with a 300 to 600 mg loading dose In the CREDO trial it was shown that a 300 mg loading dose results in a reduction of ischemic events after percutaneous coronary intervention PCI if given 6 hours prior to the procedure An antiplatelet effect similar to that achieved by chronic therapy with 75 mgday is reached within 2 hours when the high 600 mg loading is administered The 600 mg loading dose has been shown to be safe and effective in preventing thrombotic events following coronary stent implantation Recently it was shown that in patients with stable angina and administration of the 600 mg loading dose at least two hours prior to PCI concomitant therapy with a GP IIbIIIa antagonist does not result in a further reduction of the incidence of thrombotic events In contrast to a number of investigations with different loading doses no trials have been performed comparing different clopidogrel maintenance doses Recently it was shown that administration of a 600 mg loading dose in patients already on chronic clopidogrel therapy 75 mgday results in an additional significant increase in inhibition of adenosine diphosphate ADP- induced platelet aggregation Therefore it is possible that an increase of the clopidogrel maintenance dose in patients with chronic clopidogrel therapy also results in a more pronounced inhibition of platelet aggregation
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