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

Primary Purpose

ST Elevation Acute Myocardial Infarction

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Injection of Cyclosporin

Placebo

Echocardiography

About this trial

This is an interventional treatment trial for ST Elevation Acute Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Louis Pradel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cyclosporin

Control

Arm Description

one single intravenous bolus injection of 2.5 mg/Kg Echocardiography

one single intravenous bolus injection of Placebo Echocardiography

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Functional outcome

Total mortality

Cardiovascular death

Heart failure

Myocardial infarction

Unstable angina

Stroke

Infarct size

Measured by cardiac MRI, only for patients included in participating centers where cardiac MRI is part of the usual post-infarct care

Infarct size

Measured by cardiac MRI, only for patients included in participating centers where cardiac MRI is part of the usual post-infarct care

Quality of life

Assessed by the EQ-5D-3L

Adverse events

Ejection fraction

Left-ventricular End-Diastolic Volume (LVEDV)

Left-ventricular End-Systolic Volume (LVESV)

Infarct size: peak Troponin (T or I)

Microvascular obstruction

assessed by Magnetic resonance imaging

Full Information

NCT ID

NCT02934217

First Posted

October 13, 2016

Last Updated

May 17, 2018

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT02934217

Brief Title

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

Acronym

CIRCUS II

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

March 2014 (Actual)

Primary Completion Date

June 28, 2017 (Actual)

Study Completion Date

June 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ST Elevation Acute Myocardial Infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

868 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cyclosporin

Arm Type

Experimental

Arm Description

one single intravenous bolus injection of 2.5 mg/Kg Echocardiography

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

one single intravenous bolus injection of Placebo Echocardiography

Intervention Type

Drug

Intervention Name(s)

Injection of Cyclosporin

Intervention Description

one single intravenous bolus injection of 2.5 mg/Kg

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

One single intravenous bolus injection of Placebo

Intervention Type

Procedure

Intervention Name(s)

Echocardiography

Intervention Description

3 years after AMI

Primary Outcome Measure Information:

Title

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

Time Frame

at 12 months post-AMI.

Secondary Outcome Measure Information:

Title

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

Description

Functional outcome

Time Frame

until 3 years post-AMI

Title

Total mortality

Time Frame

at 12 months post-AMI.

Title

Total mortality

Time Frame

at 3 years post-AMI.

Title

Cardiovascular death

Time Frame

at 3 years post-AMI.

Title

Cardiovascular death

Time Frame

at 12 months post-AMI.

Title

Heart failure

Time Frame

at 12 months post-AMI.

Title

Heart failure

Time Frame

at 3 years post-AMI.

Title

Myocardial infarction

Time Frame

at 12 months post-AMI.

Title

Myocardial infarction

Time Frame

at 3 years post-AMI.

Title

Unstable angina

Time Frame

at 12 months post-AMI.

Title

Unstable angina

Time Frame

at 3 years post-AMI.

Title

Stroke

Time Frame

at 12 months post-AMI.

Title

Stroke

Time Frame

at 3 years post-AMI.

Title

Infarct size

Description

Measured by cardiac MRI, only for patients included in participating centers where cardiac MRI is part of the usual post-infarct care

Time Frame

at 12 months post-AMI.

Title

Infarct size

Description

Measured by cardiac MRI, only for patients included in participating centers where cardiac MRI is part of the usual post-infarct care

Time Frame

at 3 years post-AMI.

Title

Quality of life

Description

Assessed by the EQ-5D-3L

Time Frame

at 3 years post-AMI.

Title

Adverse events

Time Frame

at 3 years post-AMI.

Title

Ejection fraction

Time Frame

at 12 months post-AMI

Title

Left-ventricular End-Diastolic Volume (LVEDV)

Time Frame

at 12 months post-AMI

Title

Left-ventricular End-Systolic Volume (LVESV)

Time Frame

at 12 months post-AMI

Title

Infarct size: peak Troponin (T or I)

Time Frame

at 4 hours (+/- 30 minutes) after study treatment administration

Title

Microvascular obstruction

Description

assessed by Magnetic resonance imaging

Time Frame

at 48 hours post-AMI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michel OVIZE, Prof

Organizational Affiliation

Hospices Civils de Lyon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Louis Pradel

City

Bron

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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