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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
  Purpose

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)


Condition Intervention Phase
Acute Myocardial Infarction
Device: everolimus eluting stent
Device: sirolimus eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With ST Elevation Myocardial Infarction (STEMI) (RaCES-MI Trial)

Resource links provided by NLM:


Further study details as provided by San Giuseppe Moscati Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • cardiac death, reinfarction, Target Vessel Revascularization (TVR) and definite/probable stent thrombosis [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Enrollment: 500
Study Start Date: April 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: everolimus eluting stent
second generation drug eluting stent
Device: everolimus eluting stent
experimental arm of a comparison between drug eluting stents
Other Name: XIENCE V Abbott Vascular
Active Comparator: sirolimus eluting stent
first generation drug eluting stent
Device: sirolimus eluting stent
control arm of a comparison between drug eluting stents
Other Name: CYPHER Johnson & Johnson

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684982

Locations
Italy
Division of Cardiology AO Moscati
Avellino, Italy, 83100
Sponsors and Collaborators
San Giuseppe Moscati Hospital
Investigators
Principal Investigator: EMILIO DI LORENZO, MD PHD AO MOSCATI AVELLINO ITALY
Study Director: ROSARIO SAURO, MD AO MOSCATI AVELLINO ITALY
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emilio Di Lorenzo MD PhD, Chief Interventional Cardiology, San Giuseppe Moscati Hospital
ClinicalTrials.gov Identifier: NCT01684982     History of Changes
Other Study ID Numbers: DiLOR_2012
Study First Received: September 11, 2012
Last Updated: April 1, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by San Giuseppe Moscati Hospital:
Primary PCI
Drug Eluting Stent

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014