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

NCT02934217 | Completed Phase 3 DMC

• 1 other identifier: 2013-830
• Study Type: interventional
• Target: 868
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ST Elevation Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Combined incidence of [total mortality; hospitalization for heart failure; LV remodeling (increase of LV end-diastolic volume > 15%)]

  at 12 months post-AMI.

Secondary Outcomes (22)

• Time to first event [total mortality, hospitalization for heart failure]

  until 3 years post-AMI

• Total mortality

  at 12 months post-AMI.

• Total mortality

  at 3 years post-AMI.

• Cardiovascular death

  at 3 years post-AMI.

• Cardiovascular death

  at 12 months post-AMI.

Study Arms (2)

Cyclosporin

EXPERIMENTAL

one single intravenous bolus injection of 2.5 mg/Kg Echocardiography

Drug: Injection of Cyclosporin; Procedure: Echocardiography

Control

PLACEBO COMPARATOR

one single intravenous bolus injection of Placebo Echocardiography

Drug: Placebo; Procedure: Echocardiography

Interventions

Injection of Cyclosporin DRUG

one single intravenous bolus injection of 2.5 mg/Kg

Cyclosporin

Placebo DRUG

One single intravenous bolus injection of Placebo

Control

Echocardiography PROCEDURE

3 years after AMI

Control; Cyclosporin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Louis Pradel

Bron, France

Location

Study Officials

• Michel OVIZE, Prof

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 14, 2016
• Study Start: March 1, 2014
• Primary Completion: June 28, 2017
• Study Completion: June 28, 2017
• Last Updated: May 22, 2018

Record last verified: 2018-05

Locations

FR (1)