Everolimus Stent in Myocardial Infarction

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01684982

Acronym

RaCES-MI

Enrollment

500

Registered

2012-09-13

Start date

2007-04-30

Completion date

2012-06-30

Last updated

2013-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

Primary PCI, Drug Eluting Stent

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

Interventions

DEVICEeverolimus eluting stent

experimental arm of a comparison between drug eluting stents

DEVICEsirolimus eluting stent

control arm of a comparison between drug eluting stents

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026