PROlonging Dual Antiplatelet Treatment In Patients With Coronary Artery Disease After Graded Stent-induced Intimal Hyperplasia studY (PRODIGY)

NCT00611286 Phase 4 COMPLETED

The duration of dual antiplatelet treatment (i.e. asprin and clopidogrel) after drug-eluting stent implantation is highly debated. This study will evaluate the value of extending such treatment up to 2 years after the procedure as compared to conventional treatment according to our national health institute guidelines (i.e. minimum 1 month after bare metal stent and 6 months after drug-eluting stent) on the composite endpoint of death, MI or stroke.

Details

Lead sponsor	Marco Valgimigli
Phase	Phase 4
Status	COMPLETED
Enrolment	1700
Start date	2006-12
Completion	2012-10

Conditions

• Coronary Artery Disease

Interventions

• clopidogrel treatment after bare metal stent implantation
• clopidogrel treatment after bare metal stent implantation
• clopidogrel after zotarolimus-eluting stent implantation
• clopidogrel after paclitaxel-eluting stent implantation
• clopidogrel after everolimus-eluting stent implantation
• clopidogrel after zotarolimus-eluting stent implantation
• clopidogrel after paclitaxel-eluting stent implantation
• clopidogrel after everolimus-eluting stent implantation

Primary outcomes

• Composite of death, myocardial infarction or stroke occurring in the time window from 31 days and up to 24 months after intervention. — 24 months

Countries

Italy