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Ticagrelor versus placebo to prevent cerebral ischemia in patients with low‑grade aneurysmal subarachnoid hemorrhage

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What is this trial about?

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

The study involves people who have experienced a low‑grade Aneurysmal subarachnoid hemorrhage, a type of bleeding that occurs around the brain when a small blood‑vessel balloon (aneurysm) ruptures. Participants receive either the blood‑thinner medication ticagrelor, given as an initial larger dose followed by two smaller doses each day, or a placebo, which looks the same but contains no active drug. The medication is started at the beginning of the minimally invasive endovascular treatment that is used to close the aneurysm.

The purpose of the study is to see whether the active drug can lower the risk of brain ischemia and related clot‑related problems after the bleed. Over a period of 14 days, participants are monitored for signs of blood clots that could block vessels (thromboembolic events) and for any neurological worsening. Doctors use a brain scan called MRI and a scoring system known as NIHSS to check for new areas of damage, and they also watch for a condition called delayed cerebral ischemia, which is a later reduction in blood flow that can happen after the initial bleed. After the treatment period, follow‑up visits and scans are done to assess recovery.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomisation and first dose

    After enrolment you are randomly assigned to receive either ticagrelor or a matching placebo.

    The first dose is given at the beginning of the endovascular treatment of the aneurysm.

    The initial dose is a single oral tablet containing 180 mg of ticagrelor (or a placebo tablet of the same appearance).

  2. Step 2

    Endovascular treatment procedure

    You undergo the scheduled endovascular procedure to secure the aneurysm.

    During the procedure doctors may use imaging to place coils or a stent inside the blood vessel.

    The procedure itself is part of the study protocol and is performed under standard clinical care.

  3. Step 3

    Start of twice‑daily medication

    Following the first dose you begin a 14‑day course of study medication.

    You take one oral tablet of 90 mg ticagrelor (or matching placebo) twice each day, approximately every 12 hours.

    The medication is taken with water and may be taken with or without food.

  4. Step 4

    Daily clinical monitoring

    Each day for the 14‑day treatment period you attend a brief visit or are contacted by study staff.

    During the visit your neurological status is checked using the nihss score (a scale that measures stroke severity).

    Vital signs such as blood pressure and heart rate are recorded, and you are asked about any new symptoms such as shortness of breath, bleeding, or headache.

  5. Step 5

    Early imaging assessment

    Approximately 24 hours after the endovascular procedure you undergo a magnetic resonance imaging scan (mri).

    The scan looks for new brain lesions that could indicate a clot or reduced blood flow.

  6. Step 6

    Blood laboratory checks

    Blood samples are taken at three time points: before the first dose (baseline), on day 7, and on day 15.

    The tests include measurements of uric acid and creatinine to monitor kidney function, as well as other routine safety parameters.

  7. Step 7

    Assessment for ischemic complications

    Throughout the 14‑day period you are monitored for signs of ischemic complications, which include:

    symptomatic peri‑procedural thromboembolic events (new neurological deficits),

    asymptomatic peri‑procedural thromboembolic events (clots seen on imaging without symptoms),

    And delayed cerebral ischemia (dci), which is a later reduction in blood flow that can cause neurological worsening.

  8. Step 8

    Completion of medication and day‑15 evaluation

    On day 15 you take the final dose of the study medication and the 14‑day course ends.

    A second mri scan is performed to evaluate any new lesions.

    Clinical assessment, including the nihss score and a review of any adverse events, is completed.

  9. Step 9

    Three‑month follow‑up

    Approximately three months after the procedure you attend a follow‑up visit.

    Functional outcome is measured with the modified Rankin Scale (mrs) and the Glasgow Outcome Scale‑Extended (gose).

    Quality of life is assessed using the EQ‑5D questionnaire (eq‑5d).

    Cognitive function is evaluated with the Montreal Cognitive Assessment (moca) test.

    Any late complications, such as delayed bleeding or neurological decline, are recorded.

Who can join the trial?

7 criteria

  • Be between 18 and 80 years old.
  • Have a low‑grade aneurysmal subarachnoid hemorrhage (bleeding in the brain from a small aneurysm) that scores 1‑3 on the World Federation of Neurological Surgeons (WFNS) scale, which measures how severe the symptoms are.
  • The bleeding must have happened less than 72 hours ago and the aneurysm must be planned to be treated within that time.
  • The aneurysm must be a saccular (ball‑shaped) aneurysm that is at least 4 mm in size.
  • The aneurysm must be able to be treated with an endovascular (through‑the‑blood‑vessel) procedure that uses coils inside the aneurysm; devices such as stents or flow‑diverters are not allowed.
  • You must be enrolled in a social security or similar health‑coverage plan.
  • You must sign a free, informed, written consent yourself or have a trusted representative sign it before any study tests are done.

Who cannot join the trial?

16 criteria

  • Patients with a severe bleed (called poor grade aSAH and scored WFNS 4 or 5) cannot join the study.
  • If there is a clot of blood inside the brain tissue together with the bleed (intraparenchymal hematoma), you are not eligible.
  • Anyone who is currently taking a blood‑thinning medication that stops platelets (antiplatelet drug) cannot participate.
  • People with a sudden buildup of fluid in the brain that causes symptoms (acute symptomatic hydrocephalus) or who already have a shunt placed (ventricular derivation) are excluded.
  • If a brain scan shows heavy bleeding into the fluid‑filled spaces of the brain (intraventricular hemorrhage) that fills more than half of the ventricles, you cannot join.
  • Those who already had moderate to severe disability before the bleed (a score of 3 or higher on the modified Rankin Scale) are not eligible.
  • Active abnormal bleeding or any recent bleeding outside the brain (such as a bleed in the stomach or other organs within the last 30‑60 days) or major surgery within the past 30 days will exclude you.
  • If you have had any brain bleed (intracranial hemorrhage) in the past six months, you cannot take part.
  • People who are allergic (hypersensitive) to the study drug ticagrelor or any of its ingredients are excluded.
  • Severe liver disease (hepatic failure) or severe kidney disease (kidney failure) disqualify you.
  • Anyone taking strong medicines that block the enzyme CYP3A4 (for example ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir) or drugs that interfere with the protein P‑glycoprotein cannot join.
  • Severe breathing problems such as respiratory failure, asthma, or chronic obstructive lung disease (obstructive broncho‑pneumopathy) are exclusion criteria.
  • Women who are pregnant or are breastfeeding are not allowed to participate.
  • People who are under legal guardianship, court protection, or are deprived of liberty by a judicial or administrative decision cannot be enrolled.
  • Patients with certain types of aneurysms—such as fusiform, dissecting, or thrombosed aneurysms—or aneurysms that are linked to a brain arteriovenous malformation (AVM) are excluded.
  • If you have another unruptured aneurysm that needs treatment within the next three months, you cannot take part in the trial.
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Investigated drugs

Brilique is a medication that helps prevent blood clots by stopping platelets from sticking together. In this study, patients with a mild brain bleed (low‑grade aneurysmal subarachnoid hemorrhage) took Brilique by mouth for two weeks, starting right after the doctors treated the aneurysm with a special tube‑based procedure. The purpose of the drug was to see if it could reduce the chance of new small strokes or worsening brain function caused by blocked tiny blood vessels during the first two weeks after the treatment.

What is already known about the treatment

Ticagrelor - Ticagrelor is taken by mouth as a film‑coated tablet, usually a 180 mg loading dose followed by 90 mg twice daily. It is an approved antiplatelet drug that is widely used to reduce the risk of blood clots in heart patients and is well described in medical literature. The medicine works by blocking a receptor called P2Y12 on platelets, which stops them from sticking together and forming clots. It belongs to the class of P2Y12 receptor antagonists, also known as antiplatelet agents.

Investigated diseases

Aneurysmal subarachnoid hemorrhage - Aneurysmal subarachnoid hemorrhage is bleeding that occurs in the space surrounding the brain when a weakened blood vessel (aneurysm) ruptures. The bleed usually begins with a sudden, intense headache and may be followed by nausea, vomiting, or brief loss of consciousness. In the first hours, blood spreads through the fluid‑filled spaces, irritating the brain lining and causing early neurological changes. Over the following days, the presence of blood can lead to swelling and reduced blood flow to parts of the brain, which may worsen symptoms. As the condition progresses, small clots can form near the rupture site or in downstream vessels, contributing to additional neurological deficits.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509795-42-00Protocol codeRC31/23-0369Estimated enrolment274 patientsSponsorCentre Hospitalier Universitaire De Toulouse

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