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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

15 criteria

  • 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
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Investigated drugs

  • 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.

What is already known about the treatment

  • Cilostazol

    An oral medication taken as tablets twice daily that belongs to the phosphodiesterase inhibitor class of drugs. It works by preventing blood platelets from sticking together and by dilating blood vessels, which improves blood flow in the brain and other parts of the body. The drug is primarily used to treat intermittent claudication and is being studied for potential benefits in patients with subarachnoid hemorrhage, particularly when combined with nimodipine. Its mechanism of action involves increasing cyclic AMP levels in platelets and blood vessels through selective inhibition of phosphodiesterase type III.

  • Nimodipine

    A calcium channel blocker medication that is specifically designed to affect blood vessels in the brain. It is administered orally or through intravenous infusion and is primarily used to prevent and treat vasospasm (narrowing of blood vessels) that can occur after subarachnoid hemorrhage. The medication works by blocking calcium from entering the smooth muscle cells of blood vessels, thereby preventing vessel constriction and improving blood flow to the brain. It has been established as a standard treatment for preventing neurological complications following subarachnoid hemorrhage.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516468-27-00Protocol codeD24-P009Estimated enrolment630 patientsSponsorGroupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience

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