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Ciclosporin A and Acute Myocardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00403728
First received: November 24, 2006
Last updated: April 26, 2007
Last verified: April 2007
History of Changes

November 24, 2006
April 26, 2007
September 2004
Not Provided
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 ClinicalTrials.gov 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
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Myocardial Infarction
Drug: ciclosporine A
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
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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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00403728
2004.353
Not Provided
Not Provided
Hospices Civils de Lyon
Not Provided
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