Everolimus Stent in Myocardial Infarction (RaCES-MI)

San Giuseppe Moscati Hospital

Status and phase: Completed; Phase 4

Conditions: Acute Myocardial Infarction

Treatments: Device: sirolimus eluting stent; Device: everolimus eluting stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01684982

DiLOR_2012

Details and patient eligibility

About

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)

Full 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

Enrollment: 500 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

everolimus eluting stent

Experimental group

Description:

second generation drug eluting stent

Treatment:

Device: everolimus eluting stent

sirolimus eluting stent

Active Comparator group

Description:

first generation drug eluting stent

Treatment:

Device: sirolimus eluting stent