Everolimus Stent in Myocardial Infarction (RaCES-MI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Emilio Di Lorenzo MD PhD, San Giuseppe Moscati Hospital
ClinicalTrials.gov Identifier:
NCT01684982
First received: September 11, 2012
Last updated: April 1, 2013
Last verified: April 2013

September 11, 2012
April 1, 2013
April 2007
June 2012   (final data collection date for primary outcome measure)
cardiac death, reinfarction and Target Vessel Revascularization (TVR) [ Time Frame: 36 MONTHS ] [ Designated as safety issue: No ]
Any death of cardiac origin, any myocardial infarction and any new revascularization of the infarct related artery
Target Vessel Revascularization (TVR) at 36 months follow-up [ Time Frame: 36 MONTHS ] [ Designated as safety issue: No ]
Any new revascularization of the infarct related artery
Complete list of historical versions of study NCT01684982 on ClinicalTrials.gov Archive Site
cardiac death, reinfarction, Target Vessel Revascularization (TVR) and definite/probable stent thrombosis [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
cardiac death, non fatal MI at 36 months follow-up. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Not Provided
incidence of definite, probable or possible stent thrombosis [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
 
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)

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)

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myocardial Infarction
  • Device: everolimus eluting stent
    experimental arm of a comparison between drug eluting stents
    Other Name: XIENCE V Abbott Vascular
  • Device: sirolimus eluting stent
    control arm of a comparison between drug eluting stents
    Other Name: CYPHER Johnson & Johnson
  • Experimental: everolimus eluting stent
    second generation drug eluting stent
    Intervention: Device: everolimus eluting stent
  • Active Comparator: sirolimus eluting stent
    first generation drug eluting stent
    Intervention: Device: sirolimus eluting stent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01684982
DiLOR_2012
No
Emilio Di Lorenzo MD PhD, San Giuseppe Moscati Hospital
San Giuseppe Moscati Hospital
Not Provided
Principal Investigator: EMILIO DI LORENZO, MD PHD AO MOSCATI AVELLINO ITALY
Study Director: ROSARIO SAURO, MD AO MOSCATI AVELLINO ITALY
San Giuseppe Moscati Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP