Everolimus Stent in Myocardial Infarction (RaCES-MI)
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ClinicalTrials.gov Identifier: NCT01684982 |
Recruitment Status
:
Completed
First Posted
: September 13, 2012
Last Update Posted
: April 4, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Myocardial Infarction | Device: everolimus eluting stent Device: sirolimus eluting stent | Phase 4 |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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) |
Study Start Date : | April 2007 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
---|---|
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
|
- cardiac death, reinfarction and Target Vessel Revascularization (TVR) [ Time Frame: 36 MONTHS ]Any death of cardiac origin, any myocardial infarction and any new revascularization of the infarct related artery
- cardiac death, reinfarction, Target Vessel Revascularization (TVR) and definite/probable stent thrombosis [ Time Frame: 36 months ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684982
Italy | |
Division of Cardiology AO Moscati | |
Avellino, Italy, 83100 |
Principal Investigator: | EMILIO DI LORENZO, MD PHD | AO MOSCATI AVELLINO ITALY | |
Study Director: | ROSARIO SAURO, MD | AO MOSCATI AVELLINO ITALY |
Publications:
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 |
First Posted: | September 13, 2012 Key Record Dates |
Last Update Posted: | April 4, 2013 |
Last Verified: | April 2013 |
Keywords provided by Emilio Di Lorenzo MD PhD, San Giuseppe Moscati Hospital:
Primary PCI Drug Eluting Stent |
Additional relevant MeSH terms:
Infarction Myocardial Infarction ST Elevation Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
Everolimus Sirolimus Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents |