Optimal duration of dual antiplatelet therapy after stent-assisted coiling of unruptured intracranial aneurysms: A prospective randomized multicenter trial

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 528

Inclusion Criteria

1) Adults aged 19 years or older
2) Those who plans to perform coil embolization under stent-assisted unruptured cerebral aneurysm, and the number of platelets measured before the procedure corresponds to the following conditions:
a) aspirin reaction unit (ARU) < 550
b) P2Y12 reaction unit (PRU): 85~219
3) Modified Rankin Scale (mRS) Score= 2 at the screening
4) Those who has fully understand to the explanation of this study and has finally agreed.

Exclusion Criteria

1) Those who have neurological disabilities at the cerebral aneurysm procedure (mRS 3) 3)
2) Those who are allergic to aspirin and clopidogrel.
3) Those who have a high risk of excessive bleeding when taking medication, such as internal bleeding or severe stomach ulcers.
4) Those with bleeding tendency or blood clotting problems
5) Those who need to maintain anticoagulants or double antiplatelet treatment due to existing diseases such as cardiovascular disease (excluding patients who have maintained aspirin at mono and patients who need to maintain dual antiPLTs.)
6) Those at high risk of stroke (such as Moyamoya disease, cerebrovascular abnormalities, etc. in cases of atrial fibrillation patients requiring double antiplatelets or anticoagulants, intracranial or intravascular obstruction or more than 70% stenosis).
7) Those who have uncontrolled heart failure or angina.
8) Those with a malignant tumor that needs treatment
9) Those who are pregnant or breastfeeding.
10) Those who are unconscious at the time of diagnosis
11) Those with platelet reduction (<100,000/mm3)
12) Those with liver diseases (AST or ALT > 100 IU/L)
13) Kidney problem patients (Creatinine> 2 mg/dL; dialysis patients are excluded)
14) No regular follow-up observation is possible.
15) Those with medical conditions for which the expected dawn is less than two years.
16) Those deemed ineligible for this study by investigators

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Complications of thromboembolism that occurred from 1 month after treatment to 18 months after treatment. (Definition: transient ischemic attack or cerebral infarction [positive] that show symptoms corresponding to the vascular distribution area treated) If a transient ischemic attack or cerebral infarction is suspected, a diffusion MRI must be performed.

Secondary Outcome Measures

Name	Time	Method
1) Evaluate according to Thrombolysis in Myocardial infarction (TMI) bleeding criteria that occur from one month after treatment until the end of 18 months of tracking.);2) Complications that occurred within 30 days after intervention (periprocedural complication);3) Aggravation of the mRS(Modified Rankin Scale) Score for 18months after intervention ;4) Adverse events unrelated to procedures and dual antiplatelets ?Myocardial infarction that occurred during the follow-up period ?Thromboembolism (ischemia or cerebral infarction) that is not related to the intervention area that occurred during the follow-up period;5) Change of ARU(Aspirin reaction units) & PRU(P2Y12 reaction units) at 6months after intervention.