Antiplatelet therapy in endovascular treatment for cerebral aneurysms with flow diverter study
- Conditions
- Intracranial aneurysms
- Registration Number
- JPRN-jRCTs041230124
- Lead Sponsor
- Enomoto Yukiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 434
1) Patients aged 18 years or older
2) Patients who have completed flow diverter treatment for cerebral aneurysms
3) Patients with preoperative mRS 0-2
4) Patients who have received 2 or more antiplatelet agents (aspirin and clopidogrel or prasugrel) 1 or more days before treatment and continue for at least 1 month after treatment
5) Patients whose wirtten informed consent has been obtained
1) Patients with acute ruptured cerebral aneurysm within 2 weeks from onset
2) Patients with recurrent aneurysms after flow diverter treatment
3) Patients who did not receive antiplatelet agents at least 1 day before treatment
4) Patients with severe hepatic impairment (ALT/AST/total bilirubin >5 times normal) or renal impairment (CCr <30 ml/min) at pre-enrollment examination
5) Patients with a platelet count of less than 50,000/mm3 at the pre-enrollment examination
6) Patients with comorbidities that require permanent antiplatelet medication, such as coronary artery stenting
7) Patients who are judged to be inappropriate for the study by the investigators or subinvestigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bleeding events during the first year after flow diverter treatment
- Secondary Outcome Measures
Name Time Method 1) Thromboembolic events related to the territory of the target vessel during the first year after flow diverter treatment<br>2) Death within 1 year after flow diverter treatment<br>3) Composite endpoint of thromboembolic events, bleeding events, and death related to the treated vessel occurring during the first 1 year after flow diverter treatment<br>4) Composite endpoint of thromboembolic events/death related to the treated vessel occurring during the first year after flow diverter treatment