Status:
COMPLETED
A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction: EXAMINATION Study
Lead Sponsor:
Spanish Society of Cardiology
Conditions:
Myocardial Infarction
Eligibility:
All Genders
Phase:
NA
Brief Summary
This study is a prospective, randomized controlled, single blind, two-arm, multi center clinical evaluation. A total of 1500 patients will be enrolled in the study. Patient randomization will be to o...
Detailed Description
Primary PCI, with or without stenting, has been shown to result in superior long-term outcome when compared to thrombolytic therapy in patients with acute myocardial infarction (MI). Recently, severa...
Eligibility Criteria
Inclusion
- Patients presenting with a ST-elevation myocardial infarction who must meet at least one of the following criteria
- Patients presenting with a ST-elevation myocardial infarction \<12 hours after onset of symptoms who are treated with primary angioplasty + stent implantation
- Cardiogenic shock.
- Rescue PCI after failed thrombolysis.
- PCI indicated early (\<24h) after effective thrombolysis following current ESC guidelines.
- Patients presenting late ("latecomers") with ST-elevation myocardial infarction (\>12h-48h) after the onset of symptoms.
- Written informed consent.
- The patient or his/her family (in the event the patient can not be clinically available) accept clinical controls.
- Angiographic:
- Vessel size has to range between 2.25-4.0 mm by visual estimation to allow the implantation of currently available stents.
Exclusion
- Age \< 18 years.
- Pregnancy or breastfeeding.
- Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Everolimus, contrast material.
- Patients with absolute indication of being chronic treated with acenocoumarol
- Myocardial infarction due to a previously implanted stent thrombosis
- Patients with myocardial infarction that will require elective surgical coronary revascularisation within a 1 year period (example: inferior MI with severe disease in left main with surgical indication).
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
1504 Patients enrolled
Trial Details
Trial ID
NCT00828087
Start Date
December 1 2008
End Date
May 1 2015
Last Update
May 19 2015
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Ospedaliera Bolognini
Seriate, Bergamo, Italy, 24068
2
Azienda Ospedaliero Universitaria S. Anna di Ferrara
Ferrara, Italy, Italy, 44100
3
Erasmus MC, Rotterdam
Rotterdam, Rotterdam, Netherlands, 3015 GD
4
Complejo Hospitalario U. A Coruña
A Coruña, A Croruña, Spain, 15006