Everolimus Stent in Myocardial Infarction

Study Overview
=================
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

Official Title
-----------------
Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With ST Elevation Myocardial Infarction (STEMI) (RaCES-MI Trial)

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Device: everolimus eluting stent
* Device: sirolimus eluting stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All ST segment elevation myocardial infarction (STEMI) patients eligible for primary PCI Exclusion Criteria: Contraindication to dual antiplatelet therapy for 12 months Known allergy to sirolimus or everolimus Major surgical procedure planned within 1 month. History, symptoms, or findings suggestive of aortic dissection. Participation in other trials Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: everolimus eluting stent<br>second generation drug eluting stent | Device: everolimus eluting stent<br>* experimental arm of a comparison between drug eluting stents<br>* Other names: XIENCE V Abbott Vascular;|
| Active Comparator: sirolimus eluting stent<br>first generation drug eluting stent | Device: sirolimus eluting stent<br>* control arm of a comparison between drug eluting stents<br>* Other names: CYPHER Johnson & Johnson;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac death, reinfarction and Target Vessel Revascularization (TVR) | Any death of cardiac origin, any myocardial infarction and any new revascularization of the infarct related artery | 36 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac death, reinfarction, Target Vessel Revascularization (TVR) and definite/probable stent thrombosis |  | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary PCI, Drug Eluting Stent