Status:
COMPLETED
Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborating Sponsors:
Pusan National University Yangsan Hospital
Keimyung University Dongsan Medical Center
Conditions:
Aneurysm Cerebral
Endovascular Procedures
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
Comparison of duration of dual antiplatelet therapy after stent-assisted coiling of unruptured intracranial aneurysms
Detailed Description
The purpose of this study is to compare the incidence of thromboembolic and hemorrhagic complications between 1 and 18 months after stent-assisted coiling according to the duration of use of dual anti...
Eligibility Criteria
Inclusion
- subjects over 19 years old
- subjects with modified Rankin Scale (mRS) ≤ 2
- subjects with unruptured intracranial aneurysms
- subjects with appropriated aspirin and clopidogrel reaction units after dual antiplatelet preparation (100 mg of aspirin and 75 mg of clopidogrel) for at least 5 days before procedure \[measured using VerifyNow\]
- aspirin reaction unit (ARU) \< 550
- P2Y12 reaction unit (PRU): 85\~219
- subjects who agreed to this study (with informed consent)
Exclusion
- subjects with neurological deficits (mRS ≥ 3)
- subjects with an allergic reaction to antiplatelets (aspirin and clopidogrel) or contrast
- subjects with a high risk of hemorrhage such ICH or severe gastric ulceration
- subjects with coagulopathy
- subjects with thrombocytopenia (\<100,000/mm3)
- subjects with liver diseases (\> 100IU/L of aspartate aminotransferase or alanine aminotransferase)
- subjects with renal diseases (\> 2mg/dL of serum creatinine)
- subjects with underlying diseases that need to maintain dual antiplatelet drugs or anticoagulants.
- subjects with a high risk of strokes (atrial fibrillation, over 70% cerebral artery stenosis or cerebral artery occlusion, moyamoya disease, vascular malformations, etc)
- subjects with uncontrolled congestive heart failure or angina
- subjects with malignant tumors
- subjects with a positive pregnancy test (serum or urine)
- subjects who are unconscious at the time of diagnosis.
- subjects who are unable to complete the required follow-ups
- subjects with life-threatening diseases
- subjects with medical conditions with a life expectancy of less than two years
- subjects who are determined to be disqualified by researchers
Key Trial Info
Start Date :
June 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2025
Estimated Enrollment :
528 Patients enrolled
Trial Details
Trial ID
NCT05257824
Start Date
June 23 2022
End Date
December 2 2025
Last Update
December 19 2025
Active Locations (8)
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1
Chungnam National University Sejong Hospital
Sejong, Chungcheongnam-do, South Korea, 30099
2
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
3
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea, 50612
4
Keimyung University Dongsan Medical Center
Daegu, South Korea, 42601