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ST Elevation Acute Myocardial InfarctionPhase 3CIRCUSNCT01502774

Cyclosporine and Prognosis in Acute Myocardial Infarction (MI) Patients

A Phase 3 study testing Injection of Cyclosporin and Echocardiography in people with ST Elevation Acute Myocardial Infarction, run by Hospices Civils de Lyon at 45 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Infarct size is a major determinant of prognosis after Acute Myocardial Infarction (AMI). The investigators recently reported that cyclosporine A, when administered immediately prior to percutaneous coronary intervention (PCI), can significantly reduce infarct size in STEMI (ST Elevation acute Myocardial Infarction)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ST Elevation Acute Myocardial Infarction
What is being tested?
Injection of Cyclosporin and Echocardiography
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
970 participants
Where
45 sitesin 3 countries
Study dates
Apr 2011to Feb 2015
Phase
Phase 3
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligibility criteria (for screening before hospital admission):
  • All (male and female) patients, aged over 18, without any legal protection measure,
  • Having a health coverage,
  • Presenting within 12 hours of the onset of chest pain,
  • Who have ST segment elevation ≥0.2 mV in two contiguous leads,
  • For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI).
Show all 11Show fewer
  • And (further inclusion criteria to be confirmed by the admission coronary-angiography):
  • The culprit coronary artery has to be the LAD
  • The LAD artery has to be occluded (TIMI flow grade 0-1) at the time of admission coronary angiography.
  • 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.

Who cannot join

  • Patients with loss of consciousness or confused
  • Patients with cardiogenic shock
  • 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
  • Patients with an opened (TIMI > 1) LAD coronary artery at admission on initial (admission) coronary angiography
  • 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)
  • Patients treated with any compound containing Hypericum perforatum (St.-John's-worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine
  • Female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis).
  • 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

Trial locations and contacts

45 sites in 3 countries.

45 sites in 3 countries

France40 sites

  • Clinique ESQUIROL - SAINT-HILAIRE

    Agen, 47000

  • Centre Hospitalier du Pays D'Aix

    Aix-en-Provence, 13616

  • Centre Hospitalier Universitaire d'Angers

    Angers, 49033

  • Centre Hospitalier d'Annecy

    Annecy, 74011

  • Hôpital Henri Duffaut

    Avignon, 84000

  • Clinique Lafourcade

    Bayonne, 64100

  • Centre Hospitalier Universitaire

    Brest, 29609

  • Hopital Louis Pradel, Hospices Civils de Lyon

    Bron, 69677

  • CHRU- Hôpital de la Côte de Nacre

    Caen, 14033

  • Centre Hospitalier General

    Chartres, 28018

  • CHU - Hôpital Gabriel Montpied

    Clermont-Ferrand, 63003

  • CH de Compiègne

    Compiègne, 60321

  • CH Henri MONDOR

    Créteil, 94010

  • Hôpital du Bocage

    Dijon, 21034

  • Hôpital A. MICHALLON - CHU

    Grenoble, 38043

  • Centre Hospitalier General

    Haguenau, 67504

  • CHRU - Hôpital Cardiologique Calmette

    Lille

  • Clinique de la Sauvegarde

    Lyon, 69009

  • Centre Hospitalier St Luc St Joseph

    Lyon, 69365

  • Institut Jacques Cartier

    Massy, 91300

  • CHU Arnaud de Villeneuve

    Montpellier, 34295

  • Clinique du Millénaire

    Montpellier, 34960

  • CHU de Mulhouse

    Mulhouse, 68100

  • Clinique du Diaconat

    Mulhouse, 69607

  • Hôpital Guillaume et René Laennec

    Nantes, 44093

  • CHU de Nîmes

    Nîmes, 30029

  • Polyclinique des Fleurs

    Ollioules, 83192

  • APHP Hôpital Bichat

    Paris, 75018

  • CH de Pau

    Pau, 64011

  • Hôpital Haut Lévêque

    Pessac, 33604

  • Hôpital Claude Galien

    Quincy-sous-Sénart, 91480

  • Hôpital Pontchaillou

    Rennes, 35003

  • Hôpital Charles NICOLLE

    Rouen, 76031

  • Hôpitaux Universitaires, Nouvel Hôpital Civil

    Strasbourg, 67091

  • Clinique de l'Ormeau - CCV des Pyrénées

    Tarbes, 65000

  • CHU de Rangueil

    Toulouse, 31043

  • Clinique Saint Gatien

    Tours, 37042

  • CHRU de Tours

    Tours, 37044

  • Hôpital Brabois - CHU Nancy

    Vandœuvre-lès-Nancy, 54511

  • Clinique du Tonkin

    Villeurbanne, 69100

Other trials in France

Belgium4 sites

  • Algemeen Ziekenhuis Sint-Jan Brugge

    Bruges, 8000

  • Chu Charleroi

    Charleroi, 6000

  • Hôpital universitaire d'Anvers (UZA)

    Edegem, 2650

  • CHU Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

Spain1 site

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

Other trials in Spain

About this study

Official title: Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients

Infarct size is a major determinant of prognosis after Acute Myocardial Infarction (AMI). The investigators recently reported that cyclosporine A, when administered immediately prior to percutaneous coronary intervention (PCI), can significantly reduce infarct size in STEMI (ST Elevation acute Myocardial Infarction) patients. The objective of the present study is to determine whether cyclosporine can improve STEMI patient clinical outcome. Nine-hundred and seventy two patients with ST elevation MI will be entered into a multicentre, randomized, placebo-controlled, double-blinded study. They will receive one single injection of cyclosporine A (CicloMulsion, verum) or an equivalent volume of placebo prior to reperfusion therapy by PCI. The incidence of the combined endpoint (mortality, hospitalization for heart failure, left ventricular (LV) remodeling) will be assessed at one year and three years after treatment.

Being tested
Injection of Cyclosporin, Placebo, Echocardiography
Keywords
STEMI, cyclosporine, reperfusion injury
Medical subject headings
ST Elevation Myocardial Infarction, Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Injection of CyclosporinDrug

    Also called Cyclosporin A (CicloMulsion, verum)

    one single intravenous bolus injection of 2.5 mg/Kg

  • PlaceboDrug

    One single intravenous bolus injection of Placebo

  • EchocardiographyProcedure or surgery

    1 year after AMI

Study groups in NCT01502774
Study groupRoleWhat they receive
CyclosporinExperimentalInjection of Cyclosporin A : one single intravenous bolus injection of 2.5 mg/Kg Echocardiography
Receives: Drug: Injection of Cyclosporin; Procedure: Echocardiography
ControlPlacebo comparatorone single intravenous bolus injection of Placebo Echocardiography
Receives: Drug: Placebo; Procedure: Echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined incidence of [total mortality; hospitalization for heart failure; LV remodeling (increase of LV end-diastolic volume > 15%)]

    Measured: at 1 year post-AMI

Secondary outcomes (12)

  1. Ejection fraction

    Functional outcome

    Measured: at 1 year

  2. Left-Ventricular End-Diastolic Volume (LVEDV)

    Functional outcome

    Measured: at 1 year

  3. Left-Ventricular End-Systolic Volume (LVESV)

    Functional outcome

    Measured: at 1 year

  4. Total mortality

    Measured: at 1 year

  5. Cardiovascular death

    Measured: at 1 year

  6. Heart failure

    In-hospital worsening of heart failure after reperfusion, or rehospitalization for: a)worsening of a heart failure existing at admission, b)appearance of "new" heart failure

    Measured: at 1 year

  7. Myocardial infarction

    Measured: at 1 year

  8. Unstable angina

    Measured: at 1 year

  9. Stroke

    Measured: at 1 year

  10. Infarct size

    Measured by cardiac MRI, only for patients included in participating centers where cardiac MRI is part of the usual post-infarct care

    Measured: at 1 year

  11. Infarct size: peak Troponin (T or I)

    Explorative outcome. Cardiac prognostic factors.

    Measured: At admission and at 4 hours (+/- 30 minutes) after study treatment administration

  12. Microvascular obstruction (no reflow)

    Explorative outcome. Cardiac prognostic factors.

    Measured: During hospitalization at admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2012 (estimated)
  2. Study startApr 2011
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
970 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01502774
Sponsor's protocol ID
2009.559
Acronym
CIRCUS
Status last verified
Aug 2025
First submitted
28 Dec 2011
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26321103

  • 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.

    PubMed 31832789

  • 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.

    PubMed 26027612

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Injection of Cyclosporin and Echocardiography in people with ST Elevation Acute Myocardial Infarction, run by Hospices Civils de Lyon at 45 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in France, Belgium, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined incidence of [total mortality; hospitalization for heart failure; LV remodeling (increase of LV end-diastolic volume > 15%)] (time frame: at 1 year post-AMI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01502774, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.

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