Study of cilostazol and nimodipine combination to improve outcomes in patients with aneurysmal subarachnoid hemorrhage

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What is this study about?

This study focuses on patients with Aneurysmal Subarachnoid Hemorrhage, a condition where bleeding occurs in the space surrounding the brain due to a ruptured brain aneurysm. The research examines whether adding cilostazol to standard treatment with nimodipine can lead to better recovery for patients with this condition.

The study will compare two groups of patients – one receiving cilostazol tablets (100 mg taken twice daily) along with nimodipine, and another receiving a placebo with nimodipine. The treatment will continue for 14 days while patients are in the hospital. Both the patients and their doctors will not know which treatment group they are in during the study.

The research aims to determine if adding cilostazol to standard treatment helps improve patients’ ability to perform daily activities and live independently after six months. During the study, doctors will monitor patients for possible side effects, which may include fast heartbeat, dizziness, nausea, stomach discomfort, or bleeding. They will also track the development of any brain-related complications using various imaging techniques like CT scan and MRI.

1 Initial medication phase

After joining the study, you will receive either cilostazol tablets (100 mg) or a placebo tablet twice daily for 14 days

During this period, you will also receive nimodipine, which is a standard treatment for brain aneurysm bleeding

The medication will be taken by mouth

2 Intensive Care Unit monitoring

Your condition will be closely monitored in the Intensive Care Unit

Medical staff will check for signs of delayed brain complications, including changes in your level of consciousness or new neurological symptoms

Brain imaging tests may be performed if needed to check blood vessel condition

3 Hospital stay monitoring

Medical staff will monitor for possible medication side effects, including:

Major effects: irregular heartbeat, unusual bleeding, allergic reactions

Minor effects: fast heartbeat, fever, dizziness, nausea, vomiting, stomach pain

4 Brain imaging assessment

Brain scans will be performed within 6 weeks to check for any new changes

Different types of brain imaging may be used, including CT scan or MRI

5 Six-month follow-up

After 6 months, you will have a face-to-face meeting with medical staff

Your recovery progress will be evaluated using various assessment scales

The evaluation will include checking your physical abilities and thinking skills

Who Can Join the Study?

You must be an adult patient admitted to intensive care unit (ICU) with bleeding in the brain caused by a ruptured brain aneurysm that occurred within the last 4 days
Your brain aneurysm must have been successfully treated through either:
- Surgical clipping (a surgical procedure where a small metal clip is placed at the base of the aneurysm)
- Endovascular coiling (a minimally invasive procedure where tiny platinum coils are placed inside the aneurysm)
You must be able to provide consent to participate in the study. If you are unable to provide consent yourself, a family member or legal representative can provide consent on your behalf
You must be registered in a national healthcare system
Both men and women can participate in the study
You must be between 18 and 64 years old

Who Cannot Join the Study?

Age under 18 or over 65 years old
History of severe allergic reactions to cilostazol or nimodipine (medications used in the study)
Pregnant or breastfeeding women
Active bleeding disorders or conditions that increase bleeding risk
Severe heart conditions including:
- Heart failure
- Recent heart attack (within last 6 months)
- Unstable heart rhythm problems
Severe liver disease or kidney failure
Currently taking medications that strongly interact with study drugs
Unable to give informed consent
Participation in another clinical trial within the past 30 days
Previous brain surgery or severe head trauma
Uncontrolled high blood pressure
History of previous brain aneurysm or brain hemorrhage
Severe neurological deficits that would interfere with outcome assessment

Where you can join this trial?

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Other Sites

Site Name	City	Country
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Hospital Foch	Suresnes	France
Fondation A De Rothschild	Paris	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Geixru Hawcrrsgvii Utfesbmxnfjkj Pufbl Pqfiesgebir Er Ntsvshgajxtl	Paris	France
Cig Kvqqytr Bxxnxjj	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.04.2025

Trial locations

Investigated drugs:

CILOSTAZOL

Cilostazol is a medication that helps improve blood flow by preventing blood clots and widening blood vessels. In this trial, it is being studied for its potential to improve recovery in patients who have experienced bleeding in the brain due to a ruptured aneurysm.

Nimodipine is a medication commonly used to prevent and treat problems caused by bleeding in the brain. It works by relaxing and widening blood vessels in the brain, which helps improve blood flow and may prevent complications after brain bleeding.

Investigated diseases:

Subarachnoid haemorrhage

Aneurysmal Subarachnoid Hemorrhage – A condition where blood leaks into the space surrounding the brain due to a ruptured aneurysm (a weak spot in a blood vessel wall). The bleeding occurs in the subarachnoid space, which is the area between the brain and the thin tissues that cover it. This condition can cause sudden, severe headache, often described as the worst headache ever experienced. After the initial bleeding, the blood vessels in the brain may narrow, a process called vasospasm, which can reduce blood flow to brain tissue. The condition may lead to changes in consciousness, confusion, or focal neurological deficits.

Trial ID:

2024-516468-27-00

Protocol code:

D24-P009

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of cilostazol and nimodipine combination to improve outcomes in patients with aneurysmal subarachnoid hemorrhage

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?