Ciclosporin A and Acute Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00403728
Recruitment Status : Unknown
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : November 27, 2006
Last Update Posted : April 27, 2007
Information provided by:
Hospices Civils de Lyon

November 24, 2006
November 27, 2006
April 27, 2007
September 2004
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Infarct size evaluated primarily by the area under the curve of CK and troponin I release over the first 72 hours of reperfusion.
Same as current
Complete list of historical versions of study NCT00403728 on Archive Site
  • Myocardial contractile reserve assessed by dobutamine echocardiography at day 5.
  • No reflow evaluated by MRI at day 5
  • Recovery of myocardial contraction assessed by echocardiography and MRI at month 3
Same as current
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Ciclosporin A and Acute Myocardial Infarction
Protection by Ciclosporine A During Reperfused Acute Myocardial Infarction.
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.
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Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Myocardial Infarction
Drug: ciclosporine A
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Mewton N, Croisille P, Gahide G, Rioufol G, Bonnefoy E, Sanchez I, Cung TT, Sportouch C, Angoulvant D, Finet G, André-Fouët 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):1200-5. doi: 10.1016/j.jacc.2009.10.052.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
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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:

  • 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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Hospices Civils de Lyon
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Principal Investigator: Michel Ovize, MD Hospices Civils de Lyon
Hospices Civils de Lyon
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP