MIVAR - Milrinone Infusion for VAsospam treatment in subarachnoid hemoRrhage

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire D'Angers

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Trial duration

13 Jan 2026 → 13 Jan 2026

Decision date (initial)

2024-08-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

French Ministry oh Health

External identifiers

EU CT number

2024-515994-83-00

EudraCT number

2019-002145-37

ClinicalTrials.gov

NCT04362527

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The main objective is to evaluate the efficacy of Milrinone intravenous infusion compare
to placebo to improve the neurological outcome at 3 months in patients with vasospasm
following an aneurysmal SAH.

Secondary objectives 2

1. To assess the effect of the treatment compare to placebo (mortality in intensive care unit, and at 6 months after aneurysm rupture, mortality, long term clinical outcomes with mRankin and GOS-E score at 3 and 6 monts, long term quality of life, radiologic effectiveness of the treatment, length of hospitalization in intensive care unit and in hospital ,
2. To evaluate tolerance of the treatment (haemodynamic and metabolic tolerance)

Conditions and MedDRA coding

aneurysmal subarachnoid hemorrhage with a vasospasm

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Adult patients hospitalized for aneurysmal subarachnoid hemorrhage
2. Diagnosis of vasospasm confirmed on cerebral angiographic CT-scanner
3. Delay between diagnosis of vasospasm (i.e. CT-scanner) and inclusion ≤ 6 hours
4. Patients consent or patient’s relative (or emergency procedure)

Exclusion criteria 15

1. Initial Glasgow score = 3 with bilaterally mydriasis
2. Moribund patient
3. Contraindication to Milrinone (notably obstructive cardiomyopathy)
4. Cerebral infarction in the vasospasm area already present on the CT-scanner at the time of diagnosis (lack of expected benefit of treatment according to medical judgement)
5. Cardiac failure needing ionotropic administration when randomization has to be performed
6. Not controlled Intracranial Hypertension when randomization has to be performed
7. (ICP > 25 mmHg during at least 20 min)
8. Flutter patient or with cardiac aryhtmiaby atrial fibrillation poorly tolerated
9. Major hydroelectric problems (hypokaliémia <3 mmol/L)
10. Non-affiliation to French health care coverage
11. Pregnant, nursing or parturient woman
12. Adult patient deprived of liberty by legal or administrative decision
13. Adult patient with psychiatric care under duress
14. Adult patient protected under the law (guardianship)
15. Inclusion in an other interventional study modifying usual vasospasm management

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The main primary end point is proportion of patients with a good outcome at 3 months(defined as a modified Rankin (mRS) score ≤2)

Secondary endpoints 9

1. mortality in intensive care unit, in hospital, at 3 months and 6 months after aneurysm rupture
2. long term clinical outcomes with modified Rankin score at 6 months and Glasgow Outcome scale Extended (GOS-E) score at 3 and 6 months
3. the long term quality of life with EQ-5D at baseline, 3 and 6 months
4. effectiveness of the treatment on radiologic term  Angiographic success at D7 and D14 according to angiographic CTscanner with blind radiologist’s analysis (coted as follows: No success, light success, moderate success or important success),  The volume of infarcted areas measured using the control MRI, done between 1 and 3 months after aneurysm rupture.
5. To describe flow velocity variations in middle cerebral artery due to treatment
6. length of hospitalization in intensive care unit and in hospital (including recovery centers)
7. To evaluate the length of hospitalization in intensive care unit and in hospital (including recovery centers)
8. hemodynamic tolerance :need to introduce and/or increase doses of catecholamines by + 50% during the first 24 hours (% of patients and mean doses of treatment)
9. metabolic tolerance : The occurrence of dysnatremia (<135 mmol / L or> 155 mmol / L), Daily diuresis.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire D'Angers

Sponsor organisation

Centre Hospitalier Universitaire D'Angers

Address

4 Rue Larrey

City

Angers

Postcode

49100

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire D'Angers

Contact name

Sigismond Lasocki

Public contact point

Organisation

Centre Hospitalier Universitaire D'Angers

Contact name

chef de projet

Locations

1 EU/EEA country · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications