DAPTS ACE

Phase 4

• Conditions: intracranial aneurysm

• Registration Number: JPRN-jRCTs051180141
• Lead Sponsor: Sakai Nobuyuki

Brief Summary

Incidence rate of the ischemic stroke events in 3 to 12 months under SAPT after 3 months of short-term DAPT after stent assisted embolization of intracranial aneurysm was low and no difference was confirmed compared to long-term use of DAPT. No evidence was found to support a positive recommendation for long-term DAPT for12 months after surgery.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-20
• Study Completion: 2020-04-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1 stent assisted embolization of intracranial aneurysm
2 receive aspirin and clopidogrel
3 Provided written informed consent within 30 days after embolization of intracranial aneurysm
4 20 year old or more
5 document informed consent

Exclusion Criteria

1 previous history of stent assisted embolization for target intracranial aneurysms in the past
2 withdraw anti platelet treatment is scheduled during study
3 acute ruptured (within 14 days)
4 history of allergy for aspirin or clopidogrel
5 inappropriate for withdraw DAPT at 3 months
6 baseline platelet count less than 100,000/mm3
7 need anti-coagulant treatment
8 intracranial hemorrhage or hemorrhagic tendency
9 any clinical evidence indicating the increase in bleeding risk by the investigators
10 inadequate for the study enrollment by the investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ischemic stroke during 3 to 12 months after stent assisted embolization of intracranial aneurysm

Secondary Outcome Measures

Name	Time	Method
1 death and all stroke during 3 to 12 months after stent assisted embolization of intracranial aneurysm <br>2 hemorrhagic event during 3 to 12 months after stent assisted embolization of intracranial aneurysm 3 death, stake and hemorrhagic event during 3 to 12 months after stent assisted embolization of intracranial aneurysm<br>4 pretreatment and stenosis or occlusion go stent during 3 to 12 months after stent assisted embolization of intracranial aneurysm