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Could a single drug injection during a heart attack save lives?

NCT ID NCT01502774

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether a single injection of cyclosporine, given right before opening a blocked artery, could improve outcomes for people having a major heart attack. About 970 patients received either cyclosporine or a placebo. Researchers tracked deaths, hospitalizations for heart failure, and changes in heart size over one to three years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cyclosporine (a drug that suppresses the immune system)
What this could lead to
If it works, this could provide a simple, one-time treatment during a heart attack to limit heart muscle damage and improve long-term outcomes.
What could go wrong
This is a completed phase 3 trial, but results may show no benefit over placebo. Cyclosporine can have side effects like kidney problems or high blood pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

970 people

The number who actually took part.

Start date

Apr 2011

Finished

Feb 2015

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Eligibility criteria (for screening before hospital admission): 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). And (further inclusion criteria to be confirmed by the admission coronary-angiography): 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: 1. Patients with loss of consciousness or confused 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

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Conditions

The condition(s) this trial relates to.

ischemia reperfusion injury ST-elevation myocardial infarction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ST elevation acute myocardial infarction

Contacts and locations

Locations

  • APHP Hôpital Bichat

    Paris, 75018, France

  • Algemeen Ziekenhuis Sint-Jan Brugge

    Bruges, 8000, Belgium

  • CH Henri MONDOR

    Créteil, 94010, France

  • CH de Compiègne

    Compiègne, 60321, France

  • CH de Pau

    Pau, 64011, France

  • CHRU - Hôpital Cardiologique Calmette

    Lille, France

  • CHRU de Tours

    Tours, 37044, France

  • CHRU- Hôpital de la Côte de Nacre

    Caen, 14033, France

  • CHU - Hôpital Gabriel Montpied

    Clermont-Ferrand, 63003, France

  • CHU Arnaud de Villeneuve

    Montpellier, 34295, France

  • CHU Mont-Godinne

    Yvoir, 5530, Belgium

  • CHU de Mulhouse

    Mulhouse, 68100, France

  • CHU de Nîmes

    Nîmes, 30029, France

  • CHU de Rangueil

    Toulouse, 31043, France

  • Centre Hospitalier General

    Chartres, 28018, France

  • Centre Hospitalier General

    Haguenau, 67504, France

  • Centre Hospitalier St Luc St Joseph

    Lyon, 69365, France

  • Centre Hospitalier Universitaire

    Brest, 29609, France

  • Centre Hospitalier Universitaire d'Angers

    Angers, 49033, France

  • Centre Hospitalier d'Annecy

    Annecy, 74011, France

  • Centre Hospitalier du Pays D'Aix

    Aix-en-Provence, 13616, France

  • Chu Charleroi

    Charleroi, 6000, Belgium

  • Clinique ESQUIROL - SAINT-HILAIRE

    Agen, 47000, France

  • Clinique Lafourcade

    Bayonne, 64100, France

  • Clinique Saint Gatien

    Tours, 37042, France

  • Clinique de l'Ormeau - CCV des Pyrénées

    Tarbes, 65000, France

  • Clinique de la Sauvegarde

    Lyon, 69009, France

  • Clinique du Diaconat

    Mulhouse, 69607, France

  • Clinique du Millénaire

    Montpellier, 34960, France

  • Clinique du Tonkin

    Villeurbanne, 69100, France

  • Hopital Louis Pradel, Hospices Civils de Lyon

    Bron, 69677, France

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hôpital A. MICHALLON - CHU

    Grenoble, 38043, France

  • Hôpital Brabois - CHU Nancy

    Vandœuvre-lès-Nancy, 54511, France

  • Hôpital Charles NICOLLE

    Rouen, 76031, France

  • Hôpital Claude Galien

    Quincy-sous-Sénart, 91480, France

  • Hôpital Guillaume et René Laennec

    Nantes, 44093, France

  • Hôpital Haut Lévêque

    Pessac, 33604, France

  • Hôpital Henri Duffaut

    Avignon, 84000, France

  • Hôpital Pontchaillou

    Rennes, 35003, France

  • Hôpital du Bocage

    Dijon, 21034, France

  • Hôpital universitaire d'Anvers (UZA)

    Edegem, 2650, Belgium

  • Hôpitaux Universitaires, Nouvel Hôpital Civil

    Strasbourg, 67091, France

  • Institut Jacques Cartier

    Massy, 91300, France

  • Polyclinique des Fleurs

    Ollioules, 83192, France

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