DAPTS ACE

JRCT ID: jRCTs051180141

Registered date:20/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: intracranial aneurysm
• Date of first enrollment: 04/11/2016
• Target sample size: 300
• Study type: Interventional

Intervention(s)

3 months dual anti platelet treatment following stent assisted embolization of intracranial aneurys
12 months dual anti platelet treatment following stent assisted embolization of intracranial aneurysm

Outcome(s)

• Primary Outcome: ischemic stroke during 3 to 12 months after stent assisted embolization of intracranial aneurysm

Secondary Outcome

1 death and all stroke during 3 to 12 months after stent assisted embolization of intracranial aneurysm
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
4 pretreatment and stenosis or occlusion go stent during 3 to 12 months after stent assisted embolization of intracranial aneurysm

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Sakai Nobuyuki
• Source(s) of Monetary Support: DAIICHI SANKYO CO.,LTD
• Secondary ID(s): UMIN000022462