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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041230124
Enrollment
434
Registered
2024-01-05
Start date
2024-01-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial aneurysms

Interventions

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

Sponsors

Enomoto Yukiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Bleeding events during the first year after flow diverter treatment

Secondary

MeasureTime frame
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

Contacts

Public ContactHirofumi Matsubara

Gifu University Hospital

hrfm.matsubara@gmail.com+81-58-230-6271

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026