Everolimus Stent in Myocardial Infarction

Phase 4

Completed

• Conditions: Acute Myocardial Infarction

• Registration Number: NCT01684982
• Lead Sponsor: San Giuseppe Moscati Hospital

Brief Summary

Randomized trial to test the efficacy and safety of newer Drug Eluting Stent generation in patient with acute myocardial infarction treated with primary percutaneous coronary intervention (PCI)

Detailed Description

The efficacy and safety of drug-eluting stents (DES) in the treatment of coronary artery disease is well established. It is well known that Drug Eluting Stent (DES) have dramatically decreased Restenosis rates for both on-label and off-label indications. However, the concern for increased (late) stent thrombosis is still present DES implantation in patient with acute myocardial infarction is still controversial because acute coronary lesion presents the highest possible thrombotic burden Newer DES with new antiproliferative drugs and more biocompatible polymers have shown a significant reduction of (late) stent thrombosis in patients in stable condition.

Aim of the study was to asses the long term efficacy and safety on second generation everolimus eluting stent compared with first generation sirolimus eluting stent

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-13
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-01
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• All ST segment elevation myocardial infarction (STEMI) patients eligible for primary PCI

Exclusion Criteria

1. Contraindication to dual antiplatelet therapy for 12 months
2. Known allergy to sirolimus or everolimus
3. Major surgical procedure planned within 1 month.
4. History, symptoms, or findings suggestive of aortic dissection.
5. Participation in other trials
6. Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
cardiac death, reinfarction and Target Vessel Revascularization (TVR)	36 MONTHS	Any death of cardiac origin, any myocardial infarction and any new revascularization of the infarct related artery

Secondary Outcome Measures

Name	Time	Method
cardiac death, reinfarction, Target Vessel Revascularization (TVR) and definite/probable stent thrombosis	36 months

Trial Locations

Locations (1)

Division of Cardiology AO Moscati; 🇮🇹 Avellino, Italy