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NCT07821008

PHASE3

TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

Summary

Among aneurysmal subarachnoid hemorrhage (aSAH) survivors, ischemic injuries such as peri procedural thromboembolic events (TEE) and delayed cerebral ischemia (DCI) represent the most important disabling complications. However, preventive strategies are limited. Platelet activation mechanisms play a critical role in the pathophysiology of TEE and DCI. The results of several meta analyses suggested that use of antiplatelet drugs (APD) could reduce the risk of TTE/DCI. We aim to evaluate in patients with a low grade aSAH (WFNS 1 to 3) that occurred for less than 72 hours ago, the effect of 14 days course of ticagrelor vs placebo, initiated at the beginning of the endovascular treatment of the aneurysm, on the ischemic complications (peri-procedural symptomatic and asymptomatic TEE and/or neurological worsening due to DCI) occurring within 14 days of the endovascular treatment of the aneurysm.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

274

Start Date

2026-09-14

Completion Date

2029-12-14

Last Updated

2026-09-15

Healthy Volunteers

Conditions

Subarachnoid Hemorrhage, Aneurysmal Brain Ischemia Endovascular Procedure

Interventions

DRUG

Experimental group: ticagrelor

Patients with a low grade aSAH receiving ticagrelor. Ticagrelor will be administered orally just before the endovascular treatment of the ruptured aneurysm with a loading dose of 180mg, followed by 90 mg twice a day during 2 weeks.

DRUG

Control group: placebo

Patients with a low grade aSAH receiving placebo. Placebo will consist of tablets identical to ticagrelor ones, administered orally with a loading dose of 2 tablets, followed by 1 tablet twice a day during 2 weeks

Inclusion Criteria: * Age 18 - 80 years old * Low grade aneurysmal subarachnoid hemorrhage defined by a WFNS 1-3 * Aneurysmal treatment planned to be completed within 72 h after rupture * Sacciform aneurysm diameter ≥ 4 mm * Ruptured aneurysm treatable by endovascular, endo-saccular technic (stent and flow diverters are not allowed). If the aneurysm responsible of the SAH is difficult to identify, several aneurysms that may be related to the SAH can be treated during the procedure. * Affiliated person or beneficiary of a social security scheme. * Free, informed and written consent signed by the participant or truthworthy/proxy representative and the investigator (at the latest on the day of inclusion and before any examination required by the research). Exclusion Criteria: * Poor grade aSAH defined as WFNS 4 and 5 * Fusiform, dissecting, thrombosed aneurysms and aneurysm associated with brain arteriovenous malformation * Associated unruptured aneurysm requiring treatment within 3 months * History of intracranial hemorrhage within the past 6 months * Intraparenchymal hematoma associated with SAH -Ongoing antiplatelet drug * Acute symptomatic hydrocephalus or ventricular derivation * Intra-ventricular hemorrhage on admission CT scan, filling \>50% of both lateral ventricles and 3rd and 4th ventricles * Pre aSAH mRS ≥ * Active pathological bleeding and notably recent extra cranial hemorrhage (within previous 30 days), gastrointestinal hemorrhage within the past 6 months, or major surgery within 30 days * Other contra-indications to Ticagrelor: hypersensitivity to the active substance or to any of the excipients, * Severe hepatic or kidney failure, * Concomitant administration of strong CYP3A4 inhibitors(for ex ketoconazole, clarithromycine, nefazodone, ritonavir and atazanavir) drugs that interfered with P-glycoprotein transporter * Respiratory failure, asthma , obstructive broncho-pneumopathy * Pregnant and breastfeeding women * Patients under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision

Locations (7)

GH Pellegrin

Bordeaux, France

Gui de Chauliac Hospital - Montpellier University Hospital

Montpellier, France

Nord Laennec Hospital - Nantes University Hospital

Nantes, France

Fondation Adolphe de Rothschild Hospital

Paris, France

Hautepierre Hospital - Strasbourg Hospital University

Strasbourg, France

Pierre Paul Riquet Hospital - Toulouse University Hospital

Toulouse, France

Bretonneau Hospital - Tours Regional University Hospital

Tours, France