Optimal Duration of Dual Antiplatelet Therapy After Stent-assisted Coiling

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    528
  • sponsor
    Seoul National University Bundang Hospital
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Updated on 9 July 2022
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Summary

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

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.

Details
Condition Aneurysm Cerebral, Endovascular Procedures
Treatment Clopidogrel 75mg, Aspirin 100mg
Clinical Study IdentifierNCT05257824
SponsorSeoul National University Bundang Hospital
Last Modified on9 July 2022

Eligibility

 Yes No Not Sure

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
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