Aortic Valvular SurgeryPhase 3PC Pharma CVANCT00987207
Pharmacological Postconditioning During the Aortic Valvular Surgery
A Phase 3 study testing cyclosporine A and No injection in people with Aortic Valvular Surgery, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Primary objective: To evaluate the efficacy of the cyclosporin A administration to induce a cardioprotection during the valvular surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valvular Surgery
- What is being tested?
- cyclosporine A and No injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Sep 2010
- 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
- Male or females, scheduled for an aortic valvular surgery;
- 18 years of age or older.
Who cannot join
- Combined valvular and coronary surgery;
- Significant coronary artery stenosis (upper than 70%);
- Left ventricular dysfunction (ejection fraction < 40%);
- Emergency surgery and/or infectious endocarditis;
- Known cyclosporin hypersensitivity;
- History of known recent immunosuppression (< 6 months): cancer, lymphoma, positive serology for HIV, hepatitis;
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- Renal insufficiency (creatininaemia > 150 µmol/l);
- Hepatic insufficiency (prothrombin time < 50%);
- Uncontrolled arterial hypertension defined by a systolic arterial pressure > 180 mm Hg;
- Women of child bearing potential, who are pregnant or not under efficient contraception;
- Patients treated with nicorandil, sulfonylurea or rosuvastatine;
- Patients under judicial control.
Trial locations and contacts
1 site in 1 country.
About this study
Primary objective: To evaluate the efficacy of the cyclosporin A administration to induce a cardioprotection during the valvular surgery.
- Conditions
- Aortic Valvular Surgery
- Being tested
- cyclosporine A, No injection
- Keywords
- Postconditioning, cyclosporine A, myocardial ischemia, cardiac surgery, aortic valvulopathy
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclosporine ADrug
a single bolus of 2.5 mg/kg, administered before aortic cross-declamping
No injectionOther
No cyclosporine A is administered before aortic cross-declamping.
| Study group | Role | What they receive |
|---|---|---|
| cyclosporine | Experimental | A single bolus of 2.5 mg/kg cyclosporine is administered before aortic cross-declamping Receives: Drug: cyclosporine A |
| Control | Other | No cyclosporine A is administered before aortic cross-declamping Receives: Other: No injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The peak of the cardiac troponin I blood level measured during the first 72 hours of surgery follow-up.
Measured: 72 hours
Secondary outcomes (1)
Area under curve of the cardiac troponin I release, BNP, length of mechanical ventilation, length of stay in ICU, SAPS, necessity of a catecholaminergic support to assure hemodynamic stability, SAE
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startOct 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valvular SurgeryStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal CHIARI, MD, Principal investigator, Hospices Civils de Lyon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987207
- Sponsor's protocol ID
- 2007.490
- Acronym
- PC Pharma CVA
- Status last verified
- Nov 2011
- First submitted
- 29 Sep 2009
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Chiari P, Angoulvant D, Mewton N, Desebbe O, Obadia JF, Robin J, Farhat F, Jegaden O, Bastien O, Lehot JJ, Ovize M. Cyclosporine protects the heart during aortic valve surgery. Anesthesiology. 2014 Aug;121(2):232-8. doi: 10.1097/ALN.0000000000000331.
PubMed 25050491
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Postconditioning During the Aortic Valvular Surgery
- ClinicalTrials.gov ID
- NCT00987207
- Acronym / sponsor ID
- PC Pharma CVA / 2007.490
- Conditions
- Aortic Valvular Surgery
- Keywords
- Postconditioning, cyclosporine A, myocardial ischemia, cardiac surgery, aortic valvulopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 30 Sep 2009 (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.
Primary objective: To evaluate the efficacy of the cyclosporin A administration to induce a cardioprotection during the valvular surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cyclosporine | Experimental | Drug: cyclosporine AA single bolus of 2.5 mg/kg cyclosporine is administered before aortic cross-declamping |
| Control | Other | Other: No injectionNo cyclosporine A is administered before aortic cross-declamping |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or females, scheduled for an aortic valvular surgery;
- 18 years of age or older.
Key exclusion criteria (12 listed)
- Combined valvular and coronary surgery;
- Significant coronary artery stenosis (upper than 70%);
- Left ventricular dysfunction (ejection fraction < 40%);
- Emergency surgery and/or infectious endocarditis;
- Known cyclosporin hypersensitivity;
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 |
|---|---|---|
| cyclosporine Aa single bolus of 2.5 mg/kg, administered before aortic cross-declamping | Drug | cyclosporine |
| No injectionNo cyclosporine A is administered before aortic cross-declamping. | Other | Control |
Primary outcome
The peak of the cardiac troponin I blood level measured during the first 72 hours of surgery follow-up.
Time frame: 72 hours
1 secondary outcome
Area under curve of the cardiac troponin I release, BNP, length of mechanical ventilation, length of stay in ICU, SAPS, necessity of a catecholaminergic support to assure hemodynamic stability, SAE
Time frame: 72 hours
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 28 May 2019.
- Results publication: PubMed 25050491Chiari P, Angoulvant D, Mewton N, Desebbe O, Obadia JF, Robin J, Farhat F, Jegaden O, Bastien O, Lehot JJ, Ovize M. Cyclosporine protects the heart during aortic valve surgery. Anesthesiology. 2014 Aug;121(2):232-8. doi: 10.1097/ALN.0000000000000331.
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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.
Pascal CHIARI, MD principal investigator
Hospices Civils de Lyon, France
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 cyclosporine A and No injection in people with Aortic Valvular Surgery, 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 2 inclusion and 12 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 28 May 2019. 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. 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?
The peak of the cardiac troponin I blood level measured during the first 72 hours of surgery follow-up. (time frame: 72 hours). 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 NCT00987207, which also lists 1 linked publication.
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 28 May 2019.