Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT00638794
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2008-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents
Sponsor:
Cardiovascular Research Foundation, New York
Organization:
Study Overview
Official Title:
Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents
Status:
COMPLETED
Status Verified Date:
2012-08
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:
ADAPT-DES
Brief Summary:
Prospective, multicenter, registry of at least 11,000 (and up to 15,000) consecutive patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using DES without major procedural complications.
Detailed Description:
To determine:
1. the frequency, timing and correlates (clinical and angiographic) of drug-eluting stent (DES) thrombosis in a patient population with few clinical and angiographic exclusion criteria,
2. the relationship of aspirin and/or clopidogrel hyporesponsiveness, and general platelet reactivity to early and late DES thrombosis in separate phases stratified by whether the patient is taking dual (aspirin plus clopidogrel) or single (aspirin alone) antiplatelet therapy, and
3. combining the findings from the above 2 objectives, to identify a cohort representing a significant proportion of all patients at increased risk to have early and/or late DES stent thrombosis.
1. the frequency, timing and correlates (clinical and angiographic) of drug-eluting stent (DES) thrombosis in a patient population with few clinical and angiographic exclusion criteria,
2. the relationship of aspirin and/or clopidogrel hyporesponsiveness, and general platelet reactivity to early and late DES thrombosis in separate phases stratified by whether the patient is taking dual (aspirin plus clopidogrel) or single (aspirin alone) antiplatelet therapy, and
3. combining the findings from the above 2 objectives, to identify a cohort representing a significant proportion of all patients at increased risk to have early and/or late DES stent thrombosis.
Study Oversight
Has Oversight DMC:
False
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?: