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Status unknownNCT00403728Updated Apr 27, 2007

Ciclosporin A and Acute Myocardial Infarction

A Phase 2/3 interventional study of ciclosporine A in Myocardial Infarction, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2007-04-27.

Sponsored by Hospices Civils de Lyon · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2007), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

Beyond its immunosuppressive properties, ciclosporine A (CsA) can also inhibit the opening of a mitochondrial mega-channel called the permeability transition pore (mPTP). Opening of the mPTP plays a key role in cardiomyocyte death during reperfusion following a prolonged ischemic insult. Ciclosporin A has been shown to reduce infarct size when administered at reperfusion in experimental models. The objective of the present study is to determine whether administration of CsA at reperfusion in patients with ongoing acute myocardial infarction treated by coronary angioplasty might reduce infarct size.

02

Conditions studied

  • Myocardial Infarction

Keywords

  • Ischemia
  • Reperfusion
  • Myocardial infarction
  • ciclosporin A
  • acute myocardial infarction
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 60 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male and female patients, aged more than 18, with suspected first acute myocardial infarction
  • Within 12 hours of the onset of chest pain
  • With a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow >2 after direct stenting by angioplasty.

Exclusion criteria

Exclusion Criteria:

  • Hypersensibility to ciclosporine A
  • Cardiac arrest or cardiogenic shock
  • Immunosuppressive disease (\< 6 months): cancers, lymphomas, positive serology for HIV, hepatitis, etc.
  • Known renal failure or serum creatinine > 120 µmole/l at admission
  • Liver failure
  • Uncontrolled hypertension
  • Current pregnancy or women without contraception
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
60 participants

Interventions

  • Drugciclosporine A
06

What researchers measure

Primary outcomes

  1. Infarct size evaluated primarily by the area under the curve of CK and troponin I release over the first 72 hours of reperfusion.

Secondary outcomes

  1. Myocardial contractile reserve assessed by dobutamine echocardiography at day 5.

  2. No reflow evaluated by MRI at day 5

  3. Recovery of myocardial contraction assessed by echocardiography and MRI at month 3

07

Study locations

1 site
  • Michel Ovize
    Lyon, 69677, France
08

References and documents

Publications

  • Mewton N, Croisille P, Gahide G, Rioufol G, Bonnefoy E, Sanchez I, Cung TT, Sportouch C, Angoulvant D, Finet G, Andre-Fouet X, Derumeaux G, Piot C, Vernhet H, Revel D, Ovize M. Effect of cyclosporine on left ventricular remodeling after reperfused myocardial infarction. J Am Coll Cardiol. 2010 Mar 23;55(12):1200-1205. doi: 10.1016/j.jacc.2009.10.052. PubMed 20298926 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00403728
Lead sponsor
Hospices Civils de Lyon
First posted
Nov 27, 2006
Start date
Sep 2004
Last update
Apr 27, 2007

Study contacts

Michel Ovize, MD
principal investigator · Hospices Civils de Lyon
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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