Status:
COMPLETED
Cyclosporine and Prognosis in Acute Myocardial Infarction (MI) Patients
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
ST Elevation Acute Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Infarct size is a major determinant of prognosis after Acute Myocardial Infarction (AMI). The investigators recently reported that cyclosporine A, when administered immediately prior to percutaneous c...
Eligibility Criteria
Inclusion
- Eligibility criteria (for screening before hospital admission):
- All (male and female) patients, aged over 18, without any legal protection measure,
- Having a health coverage,
- Presenting within 12 hours of the onset of chest pain,
- Who have ST segment elevation ≥0.2 mV in two contiguous leads,
- For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI).
- And (further inclusion criteria to be confirmed by the admission coronary-angiography):
- The culprit coronary artery has to be the LAD
- The LAD artery has to be occluded (TIMI flow grade 0-1) at the time of admission coronary angiography.
- Preliminary oral informed consent followed by signed informed consent as soon as possible.
- Patients undergoing either primary PCI or rescue PCI are eligible for the study. Patients with previous AMI, PCI or coronary artery bypass surgery (CABG) are eligible for the study.
Exclusion
- Patients with loss of consciousness or confused
- Patients with cardiogenic shock
- Patients with the left circumflex or the right coronary artery (RCA) as the culprit artery, or with evidence of coronary collaterals to the risk region
- Patients with an opened (TIMI \> 1) LAD coronary artery at admission on initial (admission) coronary angiography
- Patients with 5.2. known hypersensitivity to cyclosporine 5.3. known hypersensitivity to egg, peanut or Soya-bean proteins 5.4. known renal insufficiency (either known creatinin clearance \< 30 ml/min/1.73m² or current medical care for severe renal insufficiency) 5.5. known liver insufficiency 5.6. uncontrolled (treated or untreated) hypertension (\> 180/110 mmHg)
- Patients treated with any compound containing Hypericum perforatum (St.-John's-worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine
- Female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis).
- Patients with any disorder associated with immunological dysfunction more recently than 6 months prior to presentation 8.2. cancer, lymphoma 8.3. known positive serology for HIV, or hepatitis
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
970 Patients enrolled
Trial Details
Trial ID
NCT01502774
Start Date
April 1 2011
End Date
February 1 2015
Last Update
September 4 2025
Active Locations (45)
Enter a location and click search to find clinical trials sorted by distance.
1
Algemeen Ziekenhuis Sint-Jan Brugge
Bruges, Belgium, 8000
2
Chu Charleroi
Charleroi, Belgium, 6000
3
Hôpital universitaire d'Anvers (UZA)
Edegem, Belgium, 2650
4
CHU Mont-Godinne
Yvoir, Belgium, 5530