Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Comparison of duration of dual antiplatelet therapy after stent-assisted coiling of unruptured intracranial aneurysms

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Collaborators: Ajou University School of Medicine; Asan Medical Center; Chungnam National University Hospital; Chungnam National University Sejong Hospital; Keimyung University Dongsan Medical Center; Pusan National University Yangsan Hospital; Seoul National University Hospital; Seoul St. Mary's Hospital; Severance Hospital; Soonchunhyang University Cheonan Hospital; Soonchunhyang University Hospital; Uijeongbu St. Mary's Hospital
• Treatments: Aspirin; Clopidogrel

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]

1. aspirin reaction unit (ARU) < 550

2. 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