Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients at 3 Years of Follow-up. CIRCUS II Study

ST Elevation Acute Myocardial Infarction Clinical Trial

— CIRCUS II  

Official title:

Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients at 3 Years of Follow-up. CIRCUS II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02934217
• Other study ID #: 2013-830
• Status: Completed
• Phase: Phase 3
• Start date: March 2014
• Est. completion date: June 28, 2017

Study information

• Verified date: May 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Infarct size is a major determinant of vital prognosis after AMI. We recently reported that cyclosporine A, when administered immediately prior to PCI reperfusion, can significantly reduce infarct size in STEMI patients. The CIRCUS study aimed at determining the impact of cyclosporine on the combined incidence of (death, hospitalization for heart failure, LV remodelling) at one year after AMI. However, many patients may display increased adverse LV remodelling beyond year 1 and develop heart failure thereafter. The present CIRCUS II trial aims at examining the 3-year clinical outcome of all patients recruited in the CIRCUS study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 868
• Est. completion date: June 28, 2017
• Est. primary completion date: June 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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 1. known hypersensitivity to cyclosporine 2. known hypersensitivity to egg, peanut or Soya-bean proteins 3. known renal insufficiency (either known creatinin clearance < 30 ml/min/1.73m² or current medical care for severe renal insufficiency)

4. known liver insufficiency 5. 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 1. cancer, lymphoma 2. known positive serology for HIV, or hepatitis

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Acute Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Drug:
• Injection of Cyclosporin
one single intravenous bolus injection of 2.5 mg/Kg
• Placebo
One single intravenous bolus injection of Placebo

Procedure:
• Echocardiography
3 years after AMI

Locations

Country	Name	City	State
France	Hôpital Louis Pradel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined incidence of [total mortality; hospitalization for heart failure; LV remodeling (increase of LV end-diastolic volume > 15%)]		at 12 months post-AMI.
Secondary	Time to first event [total mortality, hospitalization for heart failure]	Functional outcome	until 3 years post-AMI
Secondary	Total mortality		at 12 months post-AMI.
Secondary	Total mortality		at 3 years post-AMI.
Secondary	Cardiovascular death		at 3 years post-AMI.
Secondary	Cardiovascular death		at 12 months post-AMI.
Secondary	Heart failure		at 12 months post-AMI.
Secondary	Heart failure		at 3 years post-AMI.
Secondary	Myocardial infarction		at 12 months post-AMI.
Secondary	Myocardial infarction		at 3 years post-AMI.
Secondary	Unstable angina		at 12 months post-AMI.
Secondary	Unstable angina		at 3 years post-AMI.
Secondary	Stroke		at 12 months post-AMI.
Secondary	Stroke		at 3 years post-AMI.
Secondary	Infarct size	Measured by cardiac MRI, only for patients included in participating centers where cardiac MRI is part of the usual post-infarct care	at 12 months post-AMI.
Secondary	Infarct size	Measured by cardiac MRI, only for patients included in participating centers where cardiac MRI is part of the usual post-infarct care	at 3 years post-AMI.
Secondary	Quality of life	Assessed by the EQ-5D-3L	at 3 years post-AMI.
Secondary	Adverse events		at 3 years post-AMI.
Secondary	Ejection fraction		at 12 months post-AMI
Secondary	Left-ventricular End-Diastolic Volume (LVEDV)		at 12 months post-AMI
Secondary	Left-ventricular End-Systolic Volume (LVESV)		at 12 months post-AMI
Secondary	Infarct size: peak Troponin (T or I)		at 4 hours (+/- 30 minutes) after study treatment administration
Secondary	Microvascular obstruction	assessed by Magnetic resonance imaging	at 48 hours post-AMI