Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling
- Conditions
- Endovascular ProceduresAneurysm Cerebral
- Interventions
- Registration Number
- NCT05257824
- Lead Sponsor
- Seoul National University Bundang Hospital
- 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 antiplatelet agents (6 months versus 12 months) after stent-assisted coiling of unruptured intracranial aneurysms to determine the optimal duration of use of dual antiplatelet agents.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 528
-
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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description short-term dual antiplatelet group Clopidogrel 75mg 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 short-term dual antiplatelet group Aspirin 100mg 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 long-term dual antiplatelet group Aspirin 100mg 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. long-term dual antiplatelet group Clopidogrel 75mg 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.
- Primary Outcome Measures
Name Time Method Incidence of thromboembolic complications between 1 and 18 months after stent-assisted coil embolization The primary outcome measure is incidence of thromboembolic complications between 1 and 18 months post-procedure.
- Secondary Outcome Measures
Name Time Method Incidence of periprocedural complications during procedure and within 1 month post-procedure Incidence of periprocedural complications during procedure and within 1 month post-procedure
Incidence of hemorrhagic complications between 1 and 18 months after stent-assisted coil embolization Incidence of hemorrhagic complications between 1 and 18 months post-procedure.
Changes of modified Rankin scale in clinical and functional outcomes at 18 months follow up within 18 months post-procedure Changes in clinical and functional outcomes at 18 months follow up, as measured by an increase in the modified Rankin Scale compared to baseline (modified Rankin Scale: 0) no symptoms, 1) able to carry out all usual activities, despite some symptoms, 2) able to look after own affairs without assistance, but unable to carry out all previous activities, 3) requires some help, but able to wal unassisted, 4) unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5) requires constant nursing care and attention, bedridden, incontinent and 6) dead.
Incidence of unrelated complication with this study within 18 months post-procedure Incidence of myocardial infarction and unrelated thromboembolic or hemorrhagic complications with this study
Changes in aspirin reaction unit and P2Y12 reaction units at 6 months follow-up by using VerifyNow at 6 months Change in aspirin reaction unit and P2Y12 reaction unit at the time of 6 months follow-up compared to baseline by using VerifyNow (Accumetrics, USA)
Periprocedural mortality within 1 month Death within 1 month
Comparison of mortality between 1 and 18 months after stent-assisted coil embolization Death between 1 and 18 months post-procedure
Changes in radiological outcomes by Roy-Raymond grades at 18 months Change in radiological outcomes at 18 months follow up compared to baseline as measured by Roy-Raymond grades: 1) complete, 2) residual neck, and 3) residual sac
Trial Locations
- Locations (8)
Chungnam National University Sejong Hospital
🇰🇷Sejong, Chungcheongnam-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Gyeongsangnam-do, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Soonchunhyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Uijeongbu St. Mary's Hospital
🇰🇷Uijeongbu, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Yonsei University Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of