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

NCT02934217 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 868

Last updated 2018-05-22

No results posted yet for this study

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

Interventions

DRUG

Injection of Cyclosporin

one single intravenous bolus injection of 2.5 mg/Kg

DRUG

Placebo

One single intravenous bolus injection of Placebo

PROCEDURE

Echocardiography

3 years after AMI

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Michel OVIZE, Prof · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-06-28
Completion
2017-06-28

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02934217 on ClinicalTrials.gov