Cyclosporine and Prognosis in Acute Myocardial Infarction (MI) Patients
NCT ID: NCT01502774
Last Updated: 2025-09-04
Study Results
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Basic Information
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COMPLETED
PHASE3
970 participants
INTERVENTIONAL
2011-04-30
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cyclosporin
Injection of Cyclosporin A : one single intravenous bolus injection of 2.5 mg/Kg Echocardiography
Injection of Cyclosporin
one single intravenous bolus injection of 2.5 mg/Kg
Echocardiography
1 year after AMI
Control
one single intravenous bolus injection of Placebo Echocardiography
Placebo
One single intravenous bolus injection of Placebo
Echocardiography
1 year after AMI
Interventions
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Injection of Cyclosporin
one single intravenous bolus injection of 2.5 mg/Kg
Placebo
One single intravenous bolus injection of Placebo
Echocardiography
1 year after AMI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. All (male and female) patients, aged over 18, without any legal protection measure,
2. Having a health coverage,
3. Presenting within 12 hours of the onset of chest pain,
4. Who have ST segment elevation ≥0.2 mV in two contiguous leads,
5. For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI).
6. The culprit coronary artery has to be the LAD
7. The LAD artery has to be occluded (TIMI flow grade 0-1) at the time of admission coronary angiography.
8. 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
2. Patients with cardiogenic shock
3. 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
4. Patients with an opened (TIMI \> 1) LAD coronary artery at admission on initial (admission) coronary angiography
5. Patients with 5.2. known hypersensitivity to cyclosporine 5.3. known hypersensitivity to egg, peanut or Soya-bean proteins 5.4. known renal insufficiency (either known creatinin clearance \< 30 ml/min/1.73m² or current medical care for severe renal insufficiency) 5.5. known liver insufficiency 5.6. uncontrolled (treated or untreated) hypertension (\> 180/110 mmHg)
6. Patients treated with any compound containing Hypericum perforatum (St.-John's-worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine
7. Female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis).
8. Patients with any disorder associated with immunological dysfunction more recently than 6 months prior to presentation 8.2. cancer, lymphoma 8.3. known positive serology for HIV, or hepatitis
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Michel OVIZE, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Algemeen Ziekenhuis Sint-Jan Brugge
Bruges, , Belgium
Chu Charleroi
Charleroi, , Belgium
Hôpital universitaire d'Anvers (UZA)
Edegem, , Belgium
CHU Mont-Godinne
Yvoir, , Belgium
Clinique ESQUIROL - SAINT-HILAIRE
Agen, , France
Centre Hospitalier du Pays D'Aix
Aix-en-Provence, , France
Centre Hospitalier Universitaire d'Angers
Angers, , France
Centre Hospitalier d'Annecy
Annecy, , France
Hôpital Henri Duffaut
Avignon, , France
Clinique Lafourcade
Bayonne, , France
Centre Hospitalier Universitaire
Brest, , France
Hopital Louis Pradel, Hospices Civils de Lyon
Bron, , France
CHRU- Hôpital de la Côte de Nacre
Caen, , France
Centre Hospitalier General
Chartres, , France
CHU - Hôpital Gabriel Montpied
Clermont-Ferrand, , France
CH de Compiègne
Compiègne, , France
CH Henri MONDOR
Créteil, , France
Hôpital du Bocage
Dijon, , France
Hôpital A. MICHALLON - CHU
Grenoble, , France
Centre Hospitalier General
Haguenau, , France
CHRU - Hôpital Cardiologique Calmette
Lille, , France
Clinique de la Sauvegarde
Lyon, , France
Centre Hospitalier St Luc St Joseph
Lyon, , France
Institut Jacques Cartier
Massy, , France
CHU Arnaud de Villeneuve
Montpellier, , France
Clinique du Millénaire
Montpellier, , France
CHU de Mulhouse
Mulhouse, , France
Clinique du Diaconat
Mulhouse, , France
Hôpital Guillaume et René Laennec
Nantes, , France
CHU de Nîmes
Nîmes, , France
Polyclinique des Fleurs
Ollioules, , France
APHP Hôpital Bichat
Paris, , France
CH de Pau
Pau, , France
Hôpital Haut Lévêque
Pessac, , France
Hôpital Claude Galien
Quincy-sous-Sénart, , France
Hôpital Pontchaillou
Rennes, , France
Hôpital Charles NICOLLE
Rouen, , France
Hôpitaux Universitaires, Nouvel Hôpital Civil
Strasbourg, , France
Clinique de l'Ormeau - CCV des Pyrénées
Tarbes, , France
CHU de Rangueil
Toulouse, , France
Clinique Saint Gatien
Tours, , France
CHRU de Tours
Tours, , France
Hôpital Brabois - CHU Nancy
Vandœuvre-lès-Nancy, , France
Clinique du Tonkin
Villeurbanne, , France
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Countries
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References
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Cung TT, Morel O, Cayla G, Rioufol G, Garcia-Dorado D, Angoulvant D, Bonnefoy-Cudraz E, Guerin P, Elbaz M, Delarche N, Coste P, Vanzetto G, Metge M, Aupetit JF, Jouve B, Motreff P, Tron C, Labeque JN, Steg PG, Cottin Y, Range G, Clerc J, Claeys MJ, Coussement P, Prunier F, Moulin F, Roth O, Belle L, Dubois P, Barragan P, Gilard M, Piot C, Colin P, De Poli F, Morice MC, Ider O, Dubois-Rande JL, Unterseeh T, Le Breton H, Beard T, Blanchard D, Grollier G, Malquarti V, Staat P, Sudre A, Elmer E, Hansson MJ, Bergerot C, Boussaha I, Jossan C, Derumeaux G, Mewton N, Ovize M. Cyclosporine before PCI in Patients with Acute Myocardial Infarction. N Engl J Med. 2015 Sep 10;373(11):1021-31. doi: 10.1056/NEJMoa1505489. Epub 2015 Aug 30.
Bochaton T, Claeys MJ, Garcia-Dorado D, Mewton N, Bergerot C, Jossan C, Amaz C, Boussaha I, Thibault H, Ovize M. Importance of infarct size versus other variables for clinical outcomes after PPCI in STEMI patients. Basic Res Cardiol. 2019 Dec 12;115(1):4. doi: 10.1007/s00395-019-0764-8.
Mewton N, Cung TT, Morel O, Cayla G, Bonnefoy-Cudraz E, Rioufol G, Angoulvant D, Guerin P, Elbaz M, Delarche N, Coste P, Vanzetto G, Metge M, Aupetit JF, Jouve B, Motreff P, Tron C, Labeque JN, Steg PG, Cottin Y, Range G, Clerc J, Coussement P, Prunier F, Moulin F, Roth O, Belle L, Dubois P, Barragan P, Gilard M, Piot C, Colin P, Morice MC, Monassier JP, Ider O, Dubois-Rande JL, Unterseeh T, Lebreton H, Beard T, Blanchard D, Grollier G, Malquarti V, Staat P, Sudre A, Hansson MJ, Elmer E, Boussaha I, Jossan C, Torner A, Claeys M, Garcia-Dorado D, Ovize M; CIRCUS Study Investigators. Rationale and design of the Cyclosporine to ImpRove Clinical oUtcome in ST-elevation myocardial infarction patients (the CIRCUS trial). Am Heart J. 2015 Jun;169(6):758-766.e6. doi: 10.1016/j.ahj.2015.02.020. Epub 2015 Mar 13.
Other Identifiers
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2009.559
Identifier Type: -
Identifier Source: org_study_id
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