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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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

Treatment groups

274 Participants
are divided into 2 treatment groups
Group A: TicagrelorExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
24 hours
2

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.

Time frame
14 days

Secondary outcomes

1

Peri-procedural asymptomatic and symptomatic TEE: angiographic

It will be assessed by the occurence of one peri-procedural angiographic TEE that is, any event with clotting near the neck of the aneurysm or in distal branches and parent vessel occlusion in any vascular territory during procedure within 24 hours of aneurysmal treatment.

Time frame
24 hours
2

Peri-procedural asymptomatic and symptomatic TEE: clinical

It will be assessed by the occurence of at least one peri-procedural clinical TEE that is, symptomatic ischemic lesions defined by a worsening ≥2pts on NIHSS from baseline, not attributable to other causes within 24 hours of aneurysmal treatment.

Time frame
24 hours
3

Peri-procedural asymptomatic and symptomatic TEE: ischemic lesion

It will be assessed by the occurence of at least one severe symptomatic ischemic lesion defined by worsening \>4 points on NIHSS from baseline within 24 hours after the aneurysmal treatment.

Time frame
24 hours
4

Peri-procedural asymptomatic and symptomatic TEE: imaging

It will be assessed by the occurence of at least one peri-procedural TEE that is, acute infarctus on MRI performed within 24 hours after endovascular treatment.

Time frame
24 hours

Other outcomes

Sponsors and contacts

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