VasospasmPhase 3MIVARNCT04362527
Milrinone Infusion for VAsospam Treatment in Subarachnoid hemoRrhage
A Phase 3 study testing Milrinone 1 Mg/mL Solution for Injection and Saline solution for injection in people with Vasospasm, run by University Hospital, Angers at 16 sites in France.
Trial summary
Subarachnoid hemorrhage (SAH) is a frequent and severe disease. Mortality can reach 40%. The most frequent complication of SAH is arterial vasospasm, with estimated incidence as high as 70%. Vasospasm is responsible for cerebral ischemia leading to severe morbidity, poorer quality of life and increased mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasospasm
- What is being tested?
- Milrinone 1 Mg/mL Solution for Injection and Saline solution for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 370 participants
- Where
- 16 sitesFrance
- Study dates
- 10 Aug 2020to 12 Jan 2026
- 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
- Adult patients hospitalized for aneurysmal SAH
- First episode of vasospasm, with a diagnosis confirmed on cerebral arterial CT-scanner
- Delay between diagnosis of vasospasm (done by CT-scanner) and inclusion ≤6 hours
- Informed consent from a legal representative, or emergency procedure
Who cannot join
- Initial Glasgow score at 3 with a bilateral mydriasis
- Moribund patient
- Contraindication to Milrinone (notably obstructive cardiomyopathy…)
- Cerebral infarction in the vasospasm area already present on the CT-scanner at the time of diagnosis (lack of expected benefit of treatment in this case according to medical judgement)
- Cardiac failure requiring inotrope administration at the time of randomisation
- Uncontrolled elevated intra-cranial pressure (i.e. ICP>25 mmHg for more than 20 minutes)
Show all 14Show fewer
- Patient with flutter or cardiac arrhythmia (atrial fibrillation) poorly tolerated
- Major metabolic disturbance (uncorrected hypokalaemia <3 mmol/L)
- Non-affiliation to French health care coverage,
- Pregnant, breastfeeding or parturient woman
- Adult deprived of their liberty by judicial or administrative decision
- Adult under compulsory psychiatric care
- Adult patient protected under the law (guardianship or trusteeship)
- Inclusion in an interventional study using Milrinone, or evaluating a treatment of cerebral vasospasm or with the same primary endpoint (mRS at 3 months).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
CHU Angers
Angers
CHU Besançon
Besançon
CHU Bordeaux
Bordeaux
CHU Brest
Brest
CHU Caen
Caen
Hôpital Gabriel Montpied
Clermont-Ferrand
CHU Dijon
Dijon
CHU Lille
Lille
Hôpital Civils de Lyon
Lyon
Hôpital Gui de Chauliac
Montpellier
CHU Nantes
Nantes
APHP Lariboisière
Paris
Hôpital Fondation ROTHSCHILD
Paris
CHU Rennes
Rennes
Hôpital de Hautepierre
Strasbourg, 67098
CHU Tours
Tours
About this study
Subarachnoid hemorrhage (SAH) is a frequent and severe disease. Mortality can reach 40%. The most frequent complication of SAH is arterial vasospasm, with estimated incidence as high as 70%. Vasospasm is responsible for cerebral ischemia leading to severe morbidity, poorer quality of life and increased mortality.
Intravenous Milrinone, because of vasodilatory properties could be a therapeutic option. We hypothesize that intravenous infusion of Milrinone will improve the neurological recovery of patients with vasospasm following aneurysmal SAH at 3 months.
This is a Phase III, multi-center, randomized, double-blinded, placebo-controlled study. The primary outcome will be the proportion of patients with a good outcome 3 months (defined as a modified rankin score ≤2).
Read the detailed description
Subarachnoid hemorrhage (SAH) is relatively frequent, accounting for 5% of strokes, and affects a relatively young population. It is essentially caused by cerebral aneurysm rupture. Mortality can reach 40%. The most frequent complication of SAH is arterial vasospasm, with estimated incidence as high as 70%. Vasospasm is responsible for cerebral ischemia, delayed or not, which in turn is responsible for severe morbidity (neurological deficit, neuro psychiatric disorders...), poorer quality of life (institutionalization, inability to return to work ...) and increased mortality.
The pathophysiology of vasospasm is complex, multifactorial and far from being fully understood. Many drugs have been studied in the treatment of symptomatic vasospasm but none has really proven its efficacy. Milrinone is proposed for the treatment of cerebral vasospasm, either as intra-arterial injection (during angiography) or intravenously using continuous infusion. Indeed, among new vasospasm's treatments, Milrinone seems to have good angiographic and clinical results. There is no randomized controlled trials evaluating Milrinone for preventive and/or curative treatment of cerebral vasospasm following aneurysmal SAH. The literature is made only of clinical cases, cases series with angiographic studies or interventional studies not controlled and with no more than 10 patients.
Thus we hypothesize that the intravenous infusion of Milrinone will improve the neurological recovery of patients with vasospasm following aneurysmal SAH at 3 months.
Adult patients, hospitalized for a vasospasm complicating subarachnoid hemorrhage secondary to intracranial aneurysm rupture will be included and randomized within 6 hours of the CT-scanner confirming the vasospasm diagnosis to receive either the study drug (milrinione, a 0,1 mg/kg bolus followed by a 1 μg/kg/min perfusion) or placebo (saline, with a bolus and a continuous infusion). Study drug administration will be formalized (minimum duration 48 hours, maximum duration 14 days).The primary endpoint will be the proportion of patients with a good outcome 3 months (defined as a modified rankin score ≤2).
- Conditions
- Vasospasm
- Being tested
- Milrinone 1 Mg/mL Solution for Injection, Saline solution for injection
- Keywords
- Milrinone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milrinone 1 Mg/mL Solution for InjectionDrug
Also called Corotrope
Blinding procedure will be set up for the administration of the treatment
Saline solution for injectionDrug
Also called Sodium Chloride 0.9%
Blinding procedure will be set up for the administration of the treatment
| Study group | Role | What they receive |
|---|---|---|
| Milrinone | Experimental | The patients randomized to this arm will have Milrinone (Laboratoires STRAGEN, France) Receives: Drug: Milrinone 1 Mg/mL Solution for Injection |
| Placebo | Placebo comparator | The patients randomized to this arm will have Saline solution Receives: Drug: Saline solution for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a good outcome at 3 months
modified Rankin score ≤2 (0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death)
Measured: 3 months
Secondary outcomes (12)
Mortality rates in intensive care and in hospital
To assess mortality rates in intensive care unit and in hospital and 6 months after aneurysm rupture.
Measured: up to 6 months
Modified Rankin Score at 3 and 6 months
0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death
Measured: 3 and 6 months
Glasgow outcome scale Extended at 3 and 6 months
1= Death, 2=Persistent vegetative state, 3=Sever disability, 4=Moderate disability, 5=Good recovery 2. Persistent vegetative state
- Severe disability 4. Moderate disability 5. Low disability
Measured: up to 6 months
EQ-5D
Obtained by centralized telephone interview
Measured: up to 6 months
Evaluation of the radiologic effectiveness of the treatment
Evaluation of the angiographic success according to angiographic CT-scannerwith blind analysis (coted as follows: light success, moderate success or important success)
Measured: up to 14 days
Evaluation of the radiologic effectiveness of the treatment
Volume of infarcted areas at MRI control if available
Measured: 3 months
Evaluation of the hemodynamic tolerance of the treatment
need to introduce and/or increase doses of catecholamines by + 50% during the first 24 hours
Measured: 24 hours
Evaluation of the metabolic tolerance of the treatment
The occurrence of dysnatremia (<135 mmol / L or> 155 mmol / L), Daily diuresis.
Measured: up to 14 days
cerebral artery flow velocities
Describe treatment-related variations in middle cerebral artery flow velocities.
Measured: H0, H+2, H24+/-12h, H48+/-12h
Length of stay in the intensive care unit and in the hospital
Number of days alive in the intensive care unit and in the hospital
Measured: 3 months
live patient rate
Measured: 3 months and 6 months
Describe the number of therapeutic arteriographies
number of artheriographies
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start10 Aug 2020
- Primary completion11 Oct 2025
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VasospasmStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Factorial
- Model description
- Phase 3, multicenter, international (France, Switzerland), randomized, double blinded, placebo-controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Karim KL LAKHAL, PH, Principal investigator, University Hospital of NantesOlivier OH HUET, PU-PH, Principal investigator, Cavale Blanche - University Hospital of BrestPierre-François PP PERRIGAULT, PU-PH, Principal investigator, Hôpital Gui de Chauliac - University Hospital of MontpellierJulien JP POTTECHER, PU-PH, Principal investigator, Hôpital de Hautepierre, University Hospital of StrasbourgRussel RC CHABANNE, PH, Principal investigator, Hôpital Gabriel Montpied, University Hospital of Clermont-FerrandBenjamin BC Chousterman, PH, Principal investigator, Hôpital Lariboisière, Paris (AP-HP)Marc ML Laffon, PU-PH, Principal investigator, Hôpital Bretonneau - University Hospital of ToursYoann YL Launey, PH, Principal investigator, University Hospital of Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362527
- Sponsor's protocol ID
- 2019-002145-37
- Other IDs
- 2019
- Acronym
- MIVAR
- Status last verified
- Jan 2026
- First submitted
- 9 Apr 2020
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared later upon request (e.g., the CRF to allow a collaborator to select the data to which they wish to have access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the MIVAR investigator, based on a protocol provided by the applicant, after verification of obtaining regulatory authorizations, including the favorable opinion of an ethics committee.
Publications
Lasocki S, Lakhal K, de Courson H, Geslain M, Launey Y, Pottecher J, Trouiller P, Laffon M, Gakuba C, Parot-Schinkel E, Hamel JF, Campfort M, Gaillard T; MiVAR study group; ATLANREA group; SFAR research network. Milrinone infusion for vasospasm treatment in subarachnoid haemorrhage: protocol for a double-blind randomised clinical trial - the MiVAR study. BMJ Open. 2025 Oct 28;15(10):e101483. doi: 10.1136/bmjopen-2025-101483.
PubMed 41151960Lasocki S, Bruckert V, Campfort M, Leger M, Rineau E. Restrictive transfusion targets the heart now! Insight from the REALITY study. Anaesth Crit Care Pain Med. 2021 Apr;40(2):100854. doi: 10.1016/j.accpm.2021.100854. Epub 2021 Mar 27. No abstract available.
PubMed 33781988
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milrinone Infusion for VAsospam Treatment in Subarachnoid hemoRrhage
- ClinicalTrials.gov ID
- NCT04362527
- Acronym / sponsor ID
- MIVAR / 2019-002145-37
- Conditions
- Vasospasm
- Keywords
- Milrinone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 11 Oct 2025 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 27 Apr 2020 (actual)
- 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.
Subarachnoid hemorrhage (SAH) is a frequent and severe disease. Mortality can reach 40%. The most frequent complication of SAH is arterial vasospasm, with estimated incidence as high as 70%. Vasospasm is responsible for cerebral ischemia leading to severe morbidity, poorer quality of life and increased mortality.
Intravenous Milrinone, because of vasodilatory properties could be a therapeutic option. We hypothesize that intravenous infusion of Milrinone will improve the neurological recovery of patients with vasospasm following aneurysmal SAH at 3 months.
This is a Phase III, multi-center, randomized, double-blinded, placebo-controlled study. The primary outcome will be the proportion of patients with a good outcome 3 months (defined as a modified rankin score ≤2).
Detailed description
Subarachnoid hemorrhage (SAH) is relatively frequent, accounting for 5% of strokes, and affects a relatively young population. It is essentially caused by cerebral aneurysm rupture. Mortality can reach 40%. The most frequent complication of SAH is arterial vasospasm, with estimated incidence as high as 70%. Vasospasm is responsible for cerebral ischemia, delayed or not, which in turn is responsible for severe morbidity (neurological deficit, neuro psychiatric disorders...), poorer quality of life (institutionalization, inability to return to work ...) and increased mortality.
The pathophysiology of vasospasm is complex, multifactorial and far from being fully understood. Many drugs have been studied in the treatment of symptomatic vasospasm but none has really proven its efficacy. Milrinone is proposed for the treatment of cerebral vasospasm, either as intra-arterial injection (during angiography) or intravenously using continuous infusion. Indeed, among new vasospasm's treatments, Milrinone seems to have good angiographic and clinical results. There is no randomized controlled trials evaluating Milrinone for preventive and/or curative treatment of cerebral vasospasm following aneurysmal SAH. The literature is made only of clinical cases, cases series with angiographic studies or interventional studies not controlled and with no more than 10 patients.
Thus we hypothesize that the intravenous infusion of Milrinone will improve the neurological recovery of patients with vasospasm following aneurysmal SAH at 3 months.
Adult patients, hospitalized for a vasospasm complicating subarachnoid hemorrhage secondary to intracranial aneurysm rupture will be included and randomized within 6 hours of the CT-scanner confirming the vasospasm diagnosis to receive either the study drug (milrinione, a 0,1 mg/kg bolus followed by a 1 μg/kg/min perfusion) or placebo (saline, with a bolus and a continuous infusion). Study drug administration will be formalized (minimum duration 48 hours, maximum duration 14 days).The primary endpoint will be the proportion of patients with a good outcome 3 months (defined as a modified rankin score ≤2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Phase 3, multicenter, international (France, Switzerland), randomized, double blinded, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Milrinone | Experimental | Drug: Milrinone 1 Mg/mL Solution for InjectionThe patients randomized to this arm will have Milrinone (Laboratoires STRAGEN, France) |
| Placebo | Placebo comparator | Drug: Saline solution for injectionThe patients randomized to this arm will have Saline solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients hospitalized for aneurysmal SAH
- First episode of vasospasm, with a diagnosis confirmed on cerebral arterial CT-scanner
- Delay between diagnosis of vasospasm (done by CT-scanner) and inclusion ≤6 hours
- Informed consent from a legal representative, or emergency procedure
Key exclusion criteria (14 listed)
- Initial Glasgow score at 3 with a bilateral mydriasis
- Moribund patient
- Contraindication to Milrinone (notably obstructive cardiomyopathy…)
- Cerebral infarction in the vasospasm area already present on the CT-scanner at the time of diagnosis (lack of expected benefit of treatment in this case according to medical judgement)
- Cardiac failure requiring inotrope administration at the time of randomisation
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 |
|---|---|---|
| Milrinone 1 Mg/mL Solution for InjectionAlso: CorotropeBlinding procedure will be set up for the administration of the treatment | Drug | Milrinone |
| Saline solution for injectionAlso: Sodium Chloride 0.9%Blinding procedure will be set up for the administration of the treatment | Drug | Placebo |
Primary outcome
Proportion of patients with a good outcome at 3 months
Time frame: 3 months
modified Rankin score ≤2 (0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death)
12 secondary outcomes
Mortality rates in intensive care and in hospital
Time frame: up to 6 months
Modified Rankin Score at 3 and 6 months
Time frame: 3 and 6 months
Glasgow outcome scale Extended at 3 and 6 months
Time frame: up to 6 months
EQ-5D
Time frame: up to 6 months
Evaluation of the radiologic effectiveness of the treatment
Time frame: up to 14 days
Evaluation of the radiologic effectiveness of the treatment
Time frame: 3 months
Evaluation of the hemodynamic tolerance of the treatment
Time frame: 24 hours
Evaluation of the metabolic tolerance of the treatment
Time frame: up to 14 days
cerebral artery flow velocities
Time frame: H0, H+2, H24+/-12h, H48+/-12h
Length of stay in the intensive care unit and in the hospital
Time frame: 3 months
live patient rate
Time frame: 3 months and 6 months
Describe the number of therapeutic arteriographies
Time frame: Day 14
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 9 Mar 2026.
- Derived from this study: PubMed 41151960Lasocki S, Lakhal K, de Courson H, Geslain M, Launey Y, Pottecher J, Trouiller P, Laffon M, Gakuba C, Parot-Schinkel E, Hamel JF, Campfort M, Gaillard T; MiVAR study group; ATLANREA group; SFAR research network. Milrinone infusion for vasospasm treatment in subarachnoid haemorrhage: protocol for a double-blind randomised clinical trial - the MiVAR study. BMJ Open. 2025 Oct 28;15(10):e101483. doi: 10.1136/bmjopen-2025-101483.
- Derived from this study: PubMed 33781988Lasocki S, Bruckert V, Campfort M, Leger M, Rineau E. Restrictive transfusion targets the heart now! Insight from the REALITY study. Anaesth Crit Care Pain Med. 2021 Apr;40(2):100854. doi: 10.1016/j.accpm.2021.100854. Epub 2021 Mar 27. No abstract available.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared later upon request (e.g., the CRF to allow a collaborator to select the data to which they wish to have access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the MIVAR investigator, based on a protocol provided by the applicant, after verification of obtaining regulatory authorizations, including the favorable opinion of an ethics committee.
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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.
Karim KL LAKHAL, PH principal investigator
University Hospital of Nantes
Olivier OH HUET, PU-PH principal investigator
Cavale Blanche - University Hospital of Brest
Pierre-François PP PERRIGAULT, PU-PH principal investigator
Hôpital Gui de Chauliac - University Hospital of Montpellier
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Milrinone 1 Mg/mL Solution for Injection and Saline solution for injection in people with Vasospasm, run by University Hospital, Angers at 16 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 4 inclusion and 14 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 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 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?
Proportion of patients with a good outcome at 3 months (time frame: 3 months). 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 NCT04362527, which also lists 2 linked publications.
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 9 Mar 2026.