StrokePhase 2CsAStrokeNCT01527240
Neuroprotection Impact of Cyclosporin A in Cerebral Infarction
A Phase 2 study testing Ciclosprin A and Injectable Saline Solution. in people with Stroke, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The main objective of this study is to determine whether a single injection of CsA after intravenous thrombolysis can significantly decreased the volume of cerebral infarction at day 30 ± 15 assessed with Flair MRI. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Ciclosprin A and Injectable Saline Solution.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Dec 2013
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age ≥ 18 years and <85 years
- Male or female,
- Patients with cerebral infarction of less than 4:30H,
- NIHSS score between 6 and 18
- Identification of a carotid artery occlusion in the territory in MRI
- Consent of participation signed by the patient or, if it is unable to give the family or someone you trust if it is present.
- Patient beneficiary of a social security system.
Who cannot join
- Known hypersensitivity to cyclosporin A or castor oil, polyoxyethylene
- Patient in St. John's wort, stiripentol, bosentan or rosuvastatin
- History of immunosuppression recent (<6 months): cancer, lymphoma, positive serology for HIV, hepatitis, ...
- Known hepatic (prothrombin time <50%)
- Patients treated with sulfonylureas or nicorandil
- Patients treated with dopamine, adrenaline, noradrenaline or isoprenalin
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- Uncontrolled hypertension defined as systolic blood pressure greater than 185mm Hg and a diastolic pressure above 110 mmHg,
- Cardiogenic shock defined by systolic blood pressure below 80 mm Hg
- Contraindication to thrombolysis: History of AIC in the three months history of intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, arteriovenous malformation
- Presumption of septic embolism or aortic dissection or pericardial effusion.
- Recent biopsy or surgery within 3 months
- Head injury less than 3 months
- Known bleeding diathesis, taking anticoagulants with INR> 1.2
- Hypoglycemia (blood glucose below 0.5 mmol / l)
- Known renal, creatinine greater than 130 Mu / L
- Recent Lumbar puncture <7days
- Conditions prior psychiatric or neurological deficit does not allow objective analysis of disability
- History of ischemic stroke or hemorrhagic
- History of epilepsy and taking antiepileptic
- Structured hypodensity scanner compatible with recent ischemic stroke
- Hematoma
- Other lesions (tumor or inflammatory cerebral venous thrombosis)
- The scanner Contraindications: allergy to iodine or major renal creatinine> 130μl or MRI referred to above
- Women of childbearing age, pregnant or not recognized effective contraception
- Patients in the measure of legal protection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cyclosporin A Combined to Intravenous Thrombolysis. Multicenter Randomized Placebo-controlled
The main objective of this study is to determine whether a single injection of CsA after intravenous thrombolysis can significantly decreased the volume of cerebral infarction at day 30 ± 15 assessed with Flair MRI.
Secondary objectives are to determine whether a single injection of CsA after intravenous thrombolysis is safe and effective regarding to death and disability.
- Conditions
- Stroke
- Being tested
- Ciclosprin A, Injectable Saline Solution.
- Keywords
- Volume of cerebral infarction, Stroke, CsA, NIHSS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciclosprin ADrug
The dose in this study was 2 mg / kg, administered within 15 min after beginning of thrombolysis. The treatment of the study consists of a single bolus injection. This dose was chosen according to the results of tolerance in myocardial infarction and unknown pharmacodynamic and safety data
Injectable Saline Solution.Drug
Saline Solution is administered once 15 min after thrombolysis.
| Study group | Role | What they receive |
|---|---|---|
| Ciclosporin A | Experimental | Injection of 50 mg / ml IV infusion. 5 ml ampoules (250 mg of ciclosporin) Receives: Drug: Ciclosprin A |
| Placebo | Placebo comparator | Injectable Saline Solution. Receives: Drug: Injectable Saline Solution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine whether a single injection of CsA after intravenous thrombolysis significantly decreased the volume of cerebral infarction at day 30 ± 15 in the T2-weighted Flair MRI.
Volume of cerebral infarction at day 30 ± 15 in the T2-weighted MRI Flair will be measured by manuel contouring by two independent radiologists uninformed of clinical and therapeutic data and therapeutic
Measured: at day 30 ± 15 in the T2-weighted Flair MRI.
Secondary outcomes (1)
to determine whether a single injection of CsA after intravenous thrombolysis, is well tolerated and reduces deaths and disability in patients.
Secondary endpoints include clinical scores: NIHSS , mRS, Death, SAE (within neurological worsening of more than 4 points on the NIHSS).
Measured: on day 1, J7, J30, J90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startOct 2009
- Primary completionOct 2009
- Study completionDec 2013
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 StrokeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norbert NIGHOGHOSSIAN, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527240
- Sponsor's protocol ID
- 2008.544
- Acronym
- CsAStroke
- Status last verified
- Jan 2012
- First submitted
- 31 Jan 2012
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nighoghossian N, Berthezene Y, Mechtouff L, Derex L, Cho TH, Ritzenthaler T, Rheims S, Chauveau F, Bejot Y, Jacquin A, Giroud M, Ricolfi F, Philippeau F, Lamy C, Turc G, Bodiguel E, Domigo V, Guiraud V, Mas JL, Oppenheim C, Amarenco P, Cakmak S, Sevin-Allouet M, Guillon B, Desal H, Hosseini H, Sibon I, Mahagne MH, Ong E, Mewton N, Ovize M. Cyclosporine in acute ischemic stroke. Neurology. 2015 Jun 2;84(22):2216-23. doi: 10.1212/WNL.0000000000001639. Epub 2015 May 6.
PubMed 25948727
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
- Cyclosporin A Combined to Intravenous Thrombolysis. Multicenter Randomized Placebo-controlled
- ClinicalTrials.gov ID
- NCT01527240
- Acronym / sponsor ID
- CsAStroke / 2008.544
- Conditions
- Stroke
- Keywords
- Volume of cerebral infarction, Stroke, CsA, NIHSS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Feb 2012 (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 main objective of this study is to determine whether a single injection of CsA after intravenous thrombolysis can significantly decreased the volume of cerebral infarction at day 30 ± 15 assessed with Flair MRI.
Secondary objectives are to determine whether a single injection of CsA after intravenous thrombolysis is safe and effective regarding to death and disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciclosporin A | Experimental | Drug: Ciclosprin AInjection of 50 mg / ml IV infusion. 5 ml ampoules (250 mg of ciclosporin) |
| Placebo | Placebo comparator | Drug: Injectable Saline Solution.Injectable Saline Solution. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients age ≥ 18 years and <85 years
- Male or female,
- Patients with cerebral infarction of less than 4:30H,
- NIHSS score between 6 and 18
- Identification of a carotid artery occlusion in the territory in MRI
Key exclusion criteria (25 listed)
- Known hypersensitivity to cyclosporin A or castor oil, polyoxyethylene
- Patient in St. John's wort, stiripentol, bosentan or rosuvastatin
- History of immunosuppression recent (<6 months): cancer, lymphoma, positive serology for HIV, hepatitis, ...
- Known hepatic (prothrombin time <50%)
- Patients treated with sulfonylureas or nicorandil
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 |
|---|---|---|
| Ciclosprin AThe dose in this study was 2 mg / kg, administered within 15 min after beginning of thrombolysis. The treatment of the study consists of a single bolus injection. This dose was chosen according to the results of tolerance in myocardial infarction and unknown pharmacodynamic and safety data | Drug | Ciclosporin A |
| Injectable Saline Solution.Saline Solution is administered once 15 min after thrombolysis. | Drug | Placebo |
Primary outcome
to determine whether a single injection of CsA after intravenous thrombolysis significantly decreased the volume of cerebral infarction at day 30 ± 15 in the T2-weighted Flair MRI.
Time frame: at day 30 ± 15 in the T2-weighted Flair MRI.
Volume of cerebral infarction at day 30 ± 15 in the T2-weighted MRI Flair will be measured by manuel contouring by two independent radiologists uninformed of clinical and therapeutic data and therapeutic
1 secondary outcome
to determine whether a single injection of CsA after intravenous thrombolysis, is well tolerated and reduces deaths and disability in patients.
Time frame: on day 1, J7, J30, J90
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 25948727Nighoghossian N, Berthezene Y, Mechtouff L, Derex L, Cho TH, Ritzenthaler T, Rheims S, Chauveau F, Bejot Y, Jacquin A, Giroud M, Ricolfi F, Philippeau F, Lamy C, Turc G, Bodiguel E, Domigo V, Guiraud V, Mas JL, Oppenheim C, Amarenco P, Cakmak S, Sevin-Allouet M, Guillon B, Desal H, Hosseini H, Sibon I, Mahagne MH, Ong E, Mewton N, Ovize M. Cyclosporine in acute ischemic stroke. Neurology. 2015 Jun 2;84(22):2216-23. doi: 10.1212/WNL.0000000000001639. Epub 2015 May 6.
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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.
Norbert NIGHOGHOSSIAN 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 2 study testing Ciclosprin A and Injectable Saline Solution. in people with Stroke, 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 7 inclusion and 25 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. 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 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?
to determine whether a single injection of CsA after intravenous thrombolysis significantly decreased the volume of cerebral infarction at day 30 ± 15 in the T2-weighted Flair MRI. (time frame: at day 30 ± 15 in the T2-weighted Flair MRI.). 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 NCT01527240, 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.