Antiplatelet therapy in endovascular treatment for cerebral aneurysms with flow diverter study

JRCT ID: jRCTs041230124

Registered date:05/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Intracranial aneurysms
• Date of first enrollment: 05/01/2024
• Target sample size: 434
• Study type: Interventional

Intervention(s)

Short-term group : Dual antiplatelet therapy (aspirin and clopidogrel or prasugrel) is continued for up to 3 months, followed by monotherapy with either agent for up to 6 months after flow dieverter treatment

Long-term group : Dual antiplatelet therapy (aspirin and clopidogrel or prasugrel) is continued for at least 6 months, followed by monotherapy with either agent for at least 12 months after flow dieverter treatment

Outcome(s)

• Primary Outcome: Bleeding events during the first year after flow diverter treatment

Secondary Outcome

1) Thromboembolic events related to the territory of the target vessel during the first year after flow diverter treatment
2) Death within 1 year after flow diverter treatment
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
4) Composite endpoint of thromboembolic events/death related to the treated vessel occurring during the first year after flow diverter treatment

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Enomoto Yukiko
• Source(s) of Monetary Support: Medtronic