NCT00638794

Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8,575 (actual)
• Sponsor: Cardiovascular Research Foundation, New York · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Drug -Eluting Stent (Taxus™, Cypher®, Endeavor™, Xience V™)	PCI using any FDA approved drug-eluting stent; Taxus Express2 - Paclitaxel-Eluting Coronary Stent System Cypher Sirolimus-eluting coronary stent Endeavor ABT-578 Eluting Coronary Stent System Xience V Everolimus Eluting Coronary Stent System

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-12-01
• Completion: 2013-01-01
• First posted: 2008-03-19
• Last updated: 2013-01-23

Locations

8 sites across 1 country: United States