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

NCT07821008 | Not Yet Recruiting Phase 3 DMC

• 3 other identifiers: RC31/23/03692023-509795-42-002023
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Brain Ischemia; Endovascular Procedure; Subarachnoid Hemorrhage, Aneurysmal

Keywords

Aneurysmal subarachnoid hemorrhage; platelet aggregation inhibitors; ticagrelor; thromboembolic events; delayed cerebral ischemia

Outcome Measures

Primary Outcomes (2)

• Effect of tricagrelor on the ischemic complications: peri-procedural thromboembolic events

  It will be assessed by the occurence of symptomatic and asymptomatic peri-procedural thromboembolic events within the first 24 hours after the procedure. These events can be : * angiographic : any event with clotting near the neck of the aneurysm or in distal branches and parent vessel occlusion in any vascular territory during procedure, and/or * Clinical: worsening neurological deficit ≥2 points on NHISS from baseline after the procedure not attribuable to other causes, and/or * Imaging: acute infarctus on 24h MRI The NIHSS (National Institutes of Health Stroke Scale) is a clinical scale used primarily to assess the severity of a stroke. It consists of 15 items which assigns a score ranging from 0 to 42 (0 corresponds to no measurable deficit and 42 to the maximum neurological deficit).

  24 hours

• Effect of tricagrelor on the ischemic complications: neurological deterioration

  It will be assessed by the occurence of neurological deterioration due to delayed cerebral ischemia DCI within 14 days of the endovascular treatment. It will be caracterized by a worsening deficit (≥2 points on NIHSS scale from the previous evaluation), lasting at least 2 hours, not attributed to other causes.

  14 days

Secondary Outcomes (17)

• Peri-procedural asymptomatic and symptomatic TEE: angiographic

  24 hours

• Peri-procedural asymptomatic and symptomatic TEE: clinical

  24 hours

• Peri-procedural asymptomatic and symptomatic TEE: ischemic lesion

  24 hours

• Peri-procedural asymptomatic and symptomatic TEE: imaging

  24 hours

• Neurological deterioration and asymptomatic lesions on MRI due to DCI

  15 days

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Drug: Experimental group: ticagrelor

Placebo

PLACEBO COMPARATOR

Drug: Control group: placebo

Interventions

Experimental group: ticagrelor DRUG

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.

Ticagrelor

Control group: placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (7)

GH Pellegrin

Bordeaux, 33 000, France

Location

Gui de Chauliac Hospital - Montpellier University Hospital

Montpellier, 34 295, France

Location

Nord Laennec Hospital - Nantes University Hospital

Nantes, 44 800, France

Location

Fondation Adolphe de Rothschild Hospital

Paris, 75 019, France

Location

Hautepierre Hospital - Strasbourg Hospital University

Strasbourg, 67 200, France

Location

Pierre Paul Riquet Hospital - Toulouse University Hospital

Toulouse, 31 300, France

Location

Bretonneau Hospital - Tours Regional University Hospital

Tours, 37 000, France

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Brain Ischemia; Thromboembolism

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis

Study Officials

• Lionel Calvière

  Toulouse Hospital University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lionel Calvière, MD

CONTACT

05 61 77 94 86; calviere.l@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 15, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): December 14, 2029
• Study Completion (Estimated): December 14, 2029
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)