Myocardial InfarctionPhase 2/3NCT00403728
Ciclosporin A and Acute Myocardial Infarction
A Phase 2/3 study testing ciclosporine A in people with Myocardial Infarction, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- ciclosporine A
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2004to not given
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Myocardial Infarction
- Being tested
- ciclosporine A
- Keywords
- Ischemia, Reperfusion, Myocardial infarction, ciclosporin A, acute myocardial infarction
- Medical subject headings
- Myocardial Infarction, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciclosporine ADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Michel Ovize, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403728
- Sponsor's protocol ID
- 2004.353
- Status last verified
- Apr 2007
- First submitted
- 24 Nov 2006
- Last updated
- 27 Apr 2007
- Results posted
- No
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