Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling
Aneurysm Cerebral, Endovascular Procedures
About this trial
This is an interventional treatment trial for Aneurysm Cerebral focused on measuring dual antiplatelet, cerebral aneurysm, coil embolization, stent
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Soonchunhyang University Cheonan Hospital
- Chungnam National University Sejong HospitalRecruiting
- Soonchunhyang University Bucheon Hospital
- Seoul National University Bundang HospitalRecruiting
- Pusan National University Yangsan HospitalRecruiting
- Keimyung University Dongsan Medical Center
- Seoul National University Hospital
- Severance Hospital
- Soonchunhyang University Seoul Hospital
- Asan Medical CenterRecruiting
- Yonsei University Gangnam Severance HospitalRecruiting
- Seoul St. Mary's Hospital
- Ajou University Hospital
- Uijeongbu St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
short-term dual antiplatelet group
long-term dual antiplatelet group
Patients with unruptured intracranial aneurysms received dual antiplatelet agents (100mg of aspirin and 75mg of clopidogrel) for at least five days before coil embolization. One day prior to coiling, aspirin reaction units (ARU) and P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with proper aspirin and clopidogrel reaction units (ARU < 550 and PRU 85 ~219) will be enrolled in this study. After stent-assisted coiling, dual antiplatelet treatment continued for 6 months; after that time, this therapy will be exchanged for daily oral 100mg of aspirin for 18 months after coiling
Patients with unruptured intracranial aneurysms received dual antiplatelet agents (100mg of aspirin and 75mg of clopidogrel) for at least five days before coil embolization. One day prior to coiling, aspirin reaction units (ARU) and P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with proper aspirin and clopidogrel reaction units (ARU < 550 and PRU 85 ~219) will be enrolled in this study. After stent-assisted coiling, dual antiplatelet treatment continued for 12 months; after that time, this therapy will be exchanged for daily oral 100mg of aspirin for 18 months after coiling.