Does Cyclosporine ImpRove Clinical oUtcome in ST elevation myocardial infarction patients (CIRCUS study) - Circus
- Conditions
- acute myocardial infarctionMedDRA version: 14.1Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2009-013713-99-BE
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 970
1.All (male and female) patients, aged over 18, without any legal protection measure
2.Having a health coverage
3.Presenting within 12 hours of the onset of chest pain,
4.Who have ST segment elevation > 0.2 mV in two contiguous leads,
5.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)
6.The culprit coronary artery has to be the LAD
7.The LAD artery has to be occluded (TIMI flow grade 0-1) at the time of admission coronary angiography.
8.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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Patients with loss of consciousness or confused
2.Patients with cardiogenic shock
3.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
4.Patients with an opened (TIMI > 1) LAD coronary artery at admission on initial (admission) coronary angiography
5.Patients with
-known hypersensitivity to cyclosporine
-known renal insufficiency (either known creatinin clearance < 30 ml/min/1.73m² or current medical care for severe renal insufficiency)
-known liver insufficiency
-uncontrolled (treated or untreated) hypertension (> 180/110 mmHg)
6.Patients treated with
- any compound containing Hypericum perforatum (St.-John’s-worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine
- an active treatment that might modify blood concentration of Cyclosporine (diltiazem, vérapamil…)
7. Female patients currently pregnant or women of childbearing age who were not using contraception.
8.Patients with any disorder associated with immunological dysfunction more recently than 6 months prior to presentation
-cancer, lymphoma
-known positive serology for HIV, or hepatitis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the study is to determine whether Cyclosporine A, administered immediately prior to PCI reperfusion improves clinical outcomes in AMI patients;Secondary Objective: Secondary objectives are:<br>- to determine whether cyclosporine A, administered immediately prior to PCI reperfusion has an effect on:<br>1) Mortality events following AMI (at 30 days and 1 year)<br>2) Cardiac and vascular events following AMI<br>3) Cardiac prognostic factors<br><br>- to describe the tolerance of medicinal investigational products.<br><br>;Primary end point(s): Combined incidence of [total mortality; hospitalization for heart failure; LV remodelling (increase of LV end-diastolic volume >15%)] at one year post-AMI;Timepoint(s) of evaluation of this end point: 1 year post AMI
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Mortality events :<br>1. All causes of mortality<br>2. Cardiovascular deaths<br><br>- Cardiac and vascular events :<br>1. Heart failure: 1) in-hospital worsening of heart failure after reperfusion, 2) re-hospitalization for: a) worsening of a heart failure existing at admission, b) appearance of new” heart failure<br>2. Myocardial infarction<br>3. Unstable angina<br>4. Stroke<br>5. LV remodelling<br><br>- Cardiac prognostic factors :<br>1. Infarct size: MRI, peak Troponin (T or I)<br>2. LV function at one year<br>3. Microvascular obstruction (no reflow)<br><br>- Tolerance to medicinal investigational products <br>;Timepoint(s) of evaluation of this end point: - 30 days and 1 year for mortality events<br>- 1 year for other end points