ST Elevation Acute Myocardial InfarctionPhase 3CIRCUS IINCT02934217
Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients at 3 Years of Follow-up. CIRCUS II Study
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 1 site in France.
Trial summary
Infarct size is a major determinant of vital prognosis after AMI. We recently reported that cyclosporine A, when administered immediately prior to PCI reperfusion, can significantly reduce infarct size in STEMI patients. 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
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 868 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to 28 Jun 2017
- 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
- 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).
- And (further inclusion criteria to be confirmed by the admission coronary-angiography):
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- 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 1. known hypersensitivity to cyclosporine 2. known hypersensitivity to egg, peanut or Soya-bean proteins 3. known renal insufficiency (either known creatinin clearance < 30 ml/min/1.73m² or current medical care for severe renal insufficiency) 4. known liver insufficiency 5. 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 1. cancer, lymphoma 2. known positive serology for HIV, or hepatitis
Trial locations and contacts
1 site in 1 country.
About this study
Infarct size is a major determinant of vital prognosis after AMI. We recently reported that cyclosporine A, when administered immediately prior to PCI reperfusion, can significantly reduce infarct size in STEMI patients. The CIRCUS study aimed at determining the impact of cyclosporine on the combined incidence of (death, hospitalization for heart failure, LV remodelling) at one year after AMI. However, many patients may display increased adverse LV remodelling beyond year 1 and develop heart failure thereafter. The present CIRCUS II trial aims at examining the 3-year clinical outcome of all patients recruited in the CIRCUS study.
- Conditions
- ST Elevation Acute Myocardial Infarction
- Being tested
- Injection of Cyclosporin, Placebo, Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of CyclosporinDrug
one single intravenous bolus injection of 2.5 mg/Kg
PlaceboDrug
One single intravenous bolus injection of Placebo
EchocardiographyProcedure or surgery
3 years after AMI
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporin | Experimental | one single intravenous bolus injection of 2.5 mg/Kg Echocardiography Receives: Drug: Injection of Cyclosporin; Procedure: Echocardiography |
| Control | Placebo comparator | one 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.
Combined incidence of [total mortality; hospitalization for heart failure; LV remodeling (increase of LV end-diastolic volume > 15%)]
Measured: at 12 months post-AMI.
Secondary outcomes (22)
Time to first event [total mortality, hospitalization for heart failure]
Functional outcome
Measured: until 3 years post-AMI
Total mortality
Measured: at 12 months post-AMI.
Total mortality
Measured: at 3 years post-AMI.
Cardiovascular death
Measured: at 3 years post-AMI.
Cardiovascular death
Measured: at 12 months post-AMI.
Heart failure
Measured: at 12 months post-AMI.
Heart failure
Measured: at 3 years post-AMI.
Myocardial infarction
Measured: at 12 months post-AMI.
Myocardial infarction
Measured: at 3 years post-AMI.
Unstable angina
Measured: at 12 months post-AMI.
Unstable angina
Measured: at 3 years post-AMI.
Stroke
Measured: at 12 months post-AMI.
Stroke
Measured: at 3 years post-AMI.
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 12 months post-AMI.
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 3 years post-AMI.
Quality of life
Assessed by the EQ-5D-3L
Measured: at 3 years post-AMI.
Adverse events
Measured: at 3 years post-AMI.
Ejection fraction
Measured: at 12 months post-AMI
Left-ventricular End-Diastolic Volume (LVEDV)
Measured: at 12 months post-AMI
Left-ventricular End-Systolic Volume (LVESV)
Measured: at 12 months post-AMI
Infarct size: peak Troponin (T or I)
Measured: at 4 hours (+/- 30 minutes) after study treatment administration
Microvascular obstruction
assessed by Magnetic resonance imaging
Measured: at 48 hours post-AMI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startMar 2014
- Primary completion28 Jun 2017
- Study completion28 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 868 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel OVIZE, Prof, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934217
- Sponsor's protocol ID
- 2013-830
- Acronym
- CIRCUS II
- Status last verified
- May 2018
- First submitted
- 13 Oct 2016
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients at 3 Years of Follow-up. CIRCUS II Study
- ClinicalTrials.gov ID
- NCT02934217
- Acronym / sponsor ID
- CIRCUS II / 2013-830
- Conditions
- ST Elevation Acute Myocardial Infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 868 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 14 Oct 2016 (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.
Infarct size is a major determinant of vital prognosis after AMI. We recently reported that cyclosporine A, when administered immediately prior to PCI reperfusion, can significantly reduce infarct size in STEMI patients. The CIRCUS study aimed at determining the impact of cyclosporine on the combined incidence of (death, hospitalization for heart failure, LV remodelling) at one year after AMI. However, many patients may display increased adverse LV remodelling beyond year 1 and develop heart failure thereafter. The present CIRCUS II trial aims at examining the 3-year clinical outcome of all patients recruited in the CIRCUS study.
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 |
|---|---|---|
| Cyclosporin | Experimental | Drug: Injection of Cyclosporin, Procedure: Echocardiographyone single intravenous bolus injection of 2.5 mg/Kg Echocardiography |
| Control | Placebo comparator | Drug: Placebo, Procedure: Echocardiographyone single intravenous bolus injection of Placebo Echocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (8 listed)
- 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 1. known hypersensitivity to cyclosporine 2. known hypersensitivity to egg, peanut or Soya-bean proteins 3. known renal insufficiency (either known creatinin clearance < 30 ml/min/1.73m² or current medical care for severe renal insufficiency) 4. known liver insufficiency 5. uncontrolled (treated or untreated) hypertension (> 180/110 mmHg)
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 |
|---|---|---|
| Injection of Cyclosporinone single intravenous bolus injection of 2.5 mg/Kg | Drug | Cyclosporin |
| PlaceboOne single intravenous bolus injection of Placebo | Drug | Control |
| Echocardiography3 years after AMI | Procedure or surgery | Control, Cyclosporin |
Primary outcome
Combined incidence of [total mortality; hospitalization for heart failure; LV remodeling (increase of LV end-diastolic volume > 15%)]
Time frame: at 12 months post-AMI.
22 secondary outcomes
Time to first event [total mortality, hospitalization for heart failure]
Time frame: until 3 years post-AMI
Total mortality
Time frame: at 12 months post-AMI.
Total mortality
Time frame: at 3 years post-AMI.
Cardiovascular death
Time frame: at 3 years post-AMI.
Cardiovascular death
Time frame: at 12 months post-AMI.
Heart failure
Time frame: at 12 months post-AMI.
Heart failure
Time frame: at 3 years post-AMI.
Myocardial infarction
Time frame: at 12 months post-AMI.
Myocardial infarction
Time frame: at 3 years post-AMI.
Unstable angina
Time frame: at 12 months post-AMI.
Unstable angina
Time frame: at 3 years post-AMI.
Stroke
Time frame: at 12 months post-AMI.
Stroke
Time frame: at 3 years post-AMI.
Infarct size
Time frame: at 12 months post-AMI.
Infarct size
Time frame: at 3 years post-AMI.
Quality of life
Time frame: at 3 years post-AMI.
Adverse events
Time frame: at 3 years post-AMI.
Ejection fraction
Time frame: at 12 months post-AMI
Left-ventricular End-Diastolic Volume (LVEDV)
Time frame: at 12 months post-AMI
Left-ventricular End-Systolic Volume (LVESV)
Time frame: at 12 months post-AMI
Infarct size: peak Troponin (T or I)
Time frame: at 4 hours (+/- 30 minutes) after study treatment administration
Microvascular obstruction
Time frame: at 48 hours post-AMI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
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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.
Michel OVIZE, Prof principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
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 1 site 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 10 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 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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 12 months post-AMI.). 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 22 May 2018.