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TicAgreLor versus placebo to prevent cerebral ISCHemia in anEuRysmal low grade SAH A double blinded randomised controlled study
EU CTIS ID: 2023-509795-42-00
What this study is testing
To evaluate in patients with a low grade aSAH (WFNS 1 to 3) occurred for less than 72 hours, the effect of 14 days course of ticagrelor (bolus of 180 mg then 90 mg twice daily) vs placebo, initiated at the beginning of the endovascular treatment of the aneurysm, on the ischemic complications. The ischemic complications are defined as peri-procedural symptomatic and asymptomatic thromboembolic events and/or neurological worsening due to delayed cerebral ischemia occurring within 14 days of the endovascular treatment of the aneurysm.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 thaht may be related to the SAh can be treated during the procedure.
- Affiliated person or beneficiary of a social security scheme
You likely can't join if
- Poor grade aSAH defined as WFNS 4 and 5
- -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 ≥ 3
See the full eligibility 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 thaht 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).
- Poor grade aSAH defined as WFNS 4 and 5
- -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 ≥ 3
- 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
- History of intracranial hemorrhage within the past 6 months
- 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) and - 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
- Fusiform, dissecting, thrombosed aneurysms and aneurysm associated with brain arteriovenous malformation
- Associated unruptured aneurysm requiring treatment within 3 months
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.