Acute Myocardial InfarctionPhase 2CLOTILDENCT01901471
Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock
A Phase 2 study testing Single bolus of cyclosporine A (CicloMulsion®, Neurovive) in people with Acute Myocardial Infarction, run by Hospices Civils de Lyon at 18 sites in France.
Trial summary
The size of the acute myocardial infarction (AMI) is related to ischemia and injury induced by tissue reperfusion. These reperfusion's injuries can be reduced by injection of cyclosporin A (CsA) at the time of reperfusion. This post-conditioning reduces the final infarct size 20 to 40%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Single bolus of cyclosporine A (CicloMulsion®, Neurovive)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 18 sitesFrance
- Study dates
- Sep 2015to Oct 2015
- Phase
- Phase 2
- 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
- Patients ( male or female), aged over 18, without any legal protection measure
- Having a health coverage
- Presenting within 12 hours of the onset of chest pain, with a ST segment elevation or non ST elevation and for whom the clinical decision was made to treat with percutaneous coronary intervention (PCI) primary or rescue
- Occlusion of culprit coronary artery (TIMI flow grade = 0 or 1) at the time of admission in the catheterism laboratory
- Patient presenting a cardiogenic shock defined by a SBP<90mmhg for a period over 30 minutes and do not answering to a test of vascular charge associated with signs peripheral hypoperfusion (cold extremities, cyanosis, oliguria with urine output <50 ml/h or alteration of higher mental functions).
- Clear information is delivered to the patient or a legal representative if present and preliminary oral consent obtained, followed by obtaining written consent signed as soon as possible, in accordance with ICH.
- NB: 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
- TIMI flow grade >1
- Patients in cardiac arrest
- Patients with mechanical complication of myocardial infarction at admission (septal, broken pillar cracking or myocardial rupture, tamponade).
- Patients with other causes of hemodynamic shock: hemorrhagic, septic or anaphylactic.
- Patients with known hypersensitivity to cyclosporine, hypersensitivity to egg, peanut or Soya-bean proteins
- Renal insufficiency (either known creatinine clearance < 30 ml/min/1.73m² or current medical care for severe renal insufficiency)
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- Patients treated with any compound containing Hypericum perforatum (St. John's Wort) 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, cancer, lymphoma, known positive serology for HIV, or hepatitis
- Participation to another clinical trial
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
CH Pays d'Aix
Aix-en-Provence, 13616
Clinique de La Fourcade
Bayonne, 64100
CHU Hopital Cardiologique Louis Pradel
Bron, 69677
Hôpital Gabriel Montpied
Clermont-Ferrand, 63003
Chu Hopital Du Bocage
Dijon, 21034
Chu Hopital A Michallon
Grenoble, 38043
Hopital St Luc St Joseph
Lyon
Chu Arnaud de Villeneuve
Montpellier, 34295
Hopital Guillaume Et Rene Laennec
Nantes, 44093
Chu de Nimes
Nîmes, 30029
Aphp Hopital Bichat
Paris, 75018
Centre Hospitalier de Pau
Pau, 64011
Chu de Bordeaux
Pessac, 33604
Hopital Charles Nicolle
Rouen, 76031
Nouvel Hôpital Civil
Strasbourg, 67091
Chu de Rangueil
Toulouse, 31403
Chru de Tours
Tours, 37044
Chu de Nancy Brabois
Vandœuvre-lès-Nancy, 54511
About this study
The size of the acute myocardial infarction (AMI) is related to ischemia and injury induced by tissue reperfusion. These reperfusion's injuries can be reduced by injection of cyclosporin A (CsA) at the time of reperfusion. This post-conditioning reduces the final infarct size 20 to 40%. This has been demonstrated in STEMI patients non-complicated by cardiogenic shock. Early revascularization in the AMI complicated by cardiogenic shock improves short-term and long term survival by reducing the size of the myocardial infarction. The hypothesis of this study is that the administration of Cyclosporin A to these patients, in addition to mechanical reperfusion, is likely to reduce the severity of the multi-organ failure associated with the cardiogenic shock and improve clinical outcome.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Single bolus of Placebo of CicloMulsion® (Neurovive)., Single bolus of cyclosporine A (CicloMulsion®, Neurovive)
- Keywords
- Cyclosporine, cardiogenic shock, SOFA score,
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single bolus of Placebo of CicloMulsion® (Neurovive).Drug
The matching placebo of CicloMulsion® (Neurovive) is composed with refined Soya-bean oil, medium-chain triglycerides, egg lecithin, water-free glycerol, sodium oleate, sodium hydroxide, water injection. The qualitative composition of CicloMulsion® and its placebo only differ in the presence or absence of Cyclosporine A, so the final emulsions will be visually indistinguishable.
The placebo use here is ready-to-use lipid emulsions, i.e. do not need any step of preparation or dilution.
The placebo is provided in colourless glass bottles sealed with a rubber stopper, containing a nominal fill volume of 50 ml.
The study treatment will be directly taken into the vial and injected via a catheter positioned within an antecubital vein. The injection will be performed slowly over 2 to 3 minutes.
Single bolus of cyclosporine A (CicloMulsion®, Neurovive)Drug
The investigational medicinal product is cyclosporine A (CicloMulsion®, Neurovive).
Cyclosporine A is an immunosuppressive treatment usually used in the prevention of acute rejection after organ transplant, including cardiac transplantation. Usual dosages in organ transplantation are about 2.5 mg / kg per day in 2 doses.
CicloMulsion® is ready-to-use lipid emulsions, i.e. do not need any step of preparation or dilution.
Production blinded labelling, packaging and delivering the study drugs in every participating centre of the trial will be performed by a company following European Union's Good Manufacturing Practice.
CicloMulsion® 5mg/ml is provided in colourless glass bottles sealed with a rubber stopper, containing a nominal fill volume of 50 ml.
The study treatment will be directly taken into the vial and injected via a catheter positioned within an antecubital vein. The injection will be performed slowly over 2 to 3 minutes.
| Study group | Role | What they receive |
|---|---|---|
| CsA Group | Experimental | Not described Receives: Drug: Single bolus of cyclosporine A (CicloMulsion®, Neurovive) |
| Placebo group | Placebo comparator | Not described Receives: Drug: Single bolus of Placebo of CicloMulsion® (Neurovive). |
What is being measured
The primary outcome is the main question the study is designed to answer.
multiorgan failure evaluated by the SOFA score
The SOFA clinico-biological score takes into account the respiratory status, cardiac, hepatic, renal, neurological and the biological parameters of coagulation of the patient. This score is spread from 0 to 24 points.
Measured: At 24 hours after admission
Secondary outcomes (6)
multiorgan failure by SOFA score
The SOFA clinico-biological score takes into account the respiratory status, cardiac, hepatic, renal,neurological and the biological parameters of coagulation of the patient. This score is spread from 0 to 24 points.
Measured: At 48 hours after admission
multiorgan failure by SAPSII scores
The SAPSII score takes into account the hemodynamic, clinical, biological status of the patient. The parameters are : history of patient (type of admission, chronic disease, age), clinical parameters as systolic pressure measurement, heart rate, temperature, urine output of 24 hours and biological parameters as measurement of blood count white, serum total bilirubin, serum urea, serum sodium, serum potassium and bicarbonate level serum. pressure measurement arterial oxygen in arterial blood gases. This score is spread from 0 to 163 points.
Measured: At 24 hours and at 48 hours
Cardiac output (CO)
The hemodynamic changes will be estimated by measuring the cardiac output (CO) obtained by echocardiography.
Measured: At 24 hours after inclusion
Reduction of infarct size
evaluation of the under curve area of serum creatinin kinase (CK) measured during the 72 first hours after admission (12 blood sampling).
Measured: during the first 72 hours after admission
Reduction of cardiovascular morbidity and mortality
The incidence that occurred in one month (D30) of the following clinical criteria will be collected: death, ventricular fibrillation or ventricular tachycardia requiring electrical cardioversion, placed under mechanical cardiac support (other than against drive-by intra-aortic balloon) , reinfarction, hospitalization for heart failure.
Measured: at 1 month
Reduction of Left ventricular remodeling
Left ventricular remodeling will be assessed at 1 month among surviving patients by measurement of left ventricular end-diastolic volume by transthoracic echocardiography
Measured: at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startSep 2015
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Bonnefoy-Cudraz, MD, PhD, Principal investigator, CHU-Hôpital Cardiologique Louis Pradel BRON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901471
- Sponsor's protocol ID
- 2012.754
- Acronym
- CLOTILDE
- Status last verified
- Mar 2016
- First submitted
- 11 Jul 2013
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT01901471
- Acronym / sponsor ID
- CLOTILDE / 2012.754
- Conditions
- Acute Myocardial Infarction
- Keywords
- Cyclosporine, cardiogenic shock, SOFA score,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The size of the acute myocardial infarction (AMI) is related to ischemia and injury induced by tissue reperfusion. These reperfusion's injuries can be reduced by injection of cyclosporin A (CsA) at the time of reperfusion. This post-conditioning reduces the final infarct size 20 to 40%. This has been demonstrated in STEMI patients non-complicated by cardiogenic shock. Early revascularization in the AMI complicated by cardiogenic shock improves short-term and long term survival by reducing the size of the myocardial infarction. The hypothesis of this study is that the administration of Cyclosporin A to these patients, in addition to mechanical reperfusion, is likely to reduce the severity of the multi-organ failure associated with the cardiogenic shock and improve clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CsA Group | Experimental | Drug: Single bolus of cyclosporine A (CicloMulsion®, Neurovive) |
| Placebo group | Placebo comparator | Drug: Single bolus of Placebo of CicloMulsion® (Neurovive). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients ( male or female), aged over 18, without any legal protection measure
- Having a health coverage
- Presenting within 12 hours of the onset of chest pain, with a ST segment elevation or non ST elevation and for whom the clinical decision was made to treat with percutaneous coronary intervention (PCI) primary or rescue
- Occlusion of culprit coronary artery (TIMI flow grade = 0 or 1) at the time of admission in the catheterism laboratory
- Patient presenting a cardiogenic shock defined by a SBP<90mmhg for a period over 30 minutes and do not answering to a test of vascular charge associated with signs peripheral hypoperfusion (cold extremities, cyanosis, oliguria with urine output <50 ml/h or alteration of higher mental functions).
Key exclusion criteria (10 listed)
- TIMI flow grade >1
- Patients in cardiac arrest
- Patients with mechanical complication of myocardial infarction at admission (septal, broken pillar cracking or myocardial rupture, tamponade).
- Patients with other causes of hemodynamic shock: hemorrhagic, septic or anaphylactic.
- Patients with known hypersensitivity to cyclosporine, hypersensitivity to egg, peanut or Soya-bean proteins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single bolus of Placebo of CicloMulsion® (Neurovive).The matching placebo of CicloMulsion® (Neurovive) is composed with refined Soya-bean oil, medium-chain triglycerides, egg lecithin, water-free glycerol, sodium oleate, sodium hydroxide, water injection. The qualitative composition of CicloMulsion® and its placebo only differ in the presence or absence of Cyclosporine A, so the final emulsions will be visually indistinguishable. The placebo use here is ready-to-use lipid emulsions, i.e. do not need any step of preparation or dilution. The placebo is provided in colourless glass bottles sealed with a rubber stopper, containing a nominal fill volume of 50 ml. The study treatment will be directly taken into the vial and injected via a catheter positioned within an antecubital vein. The injection will be performed slowly over 2 to 3 minutes. | Drug | Placebo group |
| Single bolus of cyclosporine A (CicloMulsion®, Neurovive)The investigational medicinal product is cyclosporine A (CicloMulsion®, Neurovive). Cyclosporine A is an immunosuppressive treatment usually used in the prevention of acute rejection after organ transplant, including cardiac transplantation. Usual dosages in organ transplantation are about 2.5 mg / kg per day in 2 doses. CicloMulsion® is ready-to-use lipid emulsions, i.e. do not need any step of preparation or dilution. Production blinded labelling, packaging and delivering the study drugs in every participating centre of the trial will be performed by a company following European Union's Good Manufacturing Practice. CicloMulsion® 5mg/ml is provided in colourless glass bottles sealed with a rubber stopper, containing a nominal fill volume of 50 ml. The study treatment will be directly taken into the vial and injected via a catheter positioned within an antecubital vein. The injection will be performed slowly over 2 to 3 minutes. | Drug | CsA Group |
Primary outcome
multiorgan failure evaluated by the SOFA score
Time frame: At 24 hours after admission
The SOFA clinico-biological score takes into account the respiratory status, cardiac, hepatic, renal, neurological and the biological parameters of coagulation of the patient. This score is spread from 0 to 24 points.
6 secondary outcomes
multiorgan failure by SOFA score
Time frame: At 48 hours after admission
multiorgan failure by SAPSII scores
Time frame: At 24 hours and at 48 hours
Cardiac output (CO)
Time frame: At 24 hours after inclusion
Reduction of infarct size
Time frame: during the first 72 hours after admission
Reduction of cardiovascular morbidity and mortality
Time frame: at 1 month
Reduction of Left ventricular remodeling
Time frame: at 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Bonnefoy-Cudraz, MD, PhD principal investigator
CHU-Hôpital Cardiologique Louis Pradel BRON
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Single bolus of cyclosporine A (CicloMulsion®, Neurovive) in people with Acute Myocardial Infarction, run by Hospices Civils de Lyon at 18 sites in France.
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 8 inclusion and 10 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: withdrawn, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
multiorgan failure evaluated by the SOFA score (time frame: At 24 hours after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2016.