Development of antiplatelet therapy protocol for coil embolization of intracranial aneurysm

Not Applicable

Completed

• Conditions: Diseases of the nervous system

• Registration Number: KCT0000804
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

Standard vs modified antiplatelet preparation
1. Patients with intracranial aneurysm who plan to undergo coil embolization
2. Patient aged 20 years and more at the day of enrollment
3. Patient with less than 2 of modified Rankin scale score at the day of enrollment
4. Patient who agrees and writes out a consent form

Short vs long-term dual antiplatelet therapy
1. Patients with unruptured aneurysm treated with stent-assisted coiling within 30 days at the day of enrollment
2. Patient aged 20 years or more at the day of enrollment
3. Patient who agrees and writes out a consent form

Exclusion Criteria

Standard vs modified antiplatelet preparation
1. Patient with histoy of hypersensitivity of aspirin, clopidogrel, cilostazol, or prasugrel
2. Patient with high possibility of active bleeding such as symptomatic intrcranial hemorrhage or active gastric ulcer
3. Patient with bleeding tendency or coagulopathy
4. Patient with thrombocytopenia (< 100,000/mm3 of platelet count within three months before enrollment)
5. Patient with liver disease (> 100 of AST or ALT within three months before enrollment)
6. Patient with renal disease (> 2mg/dL of serum creatinin within three months before enrollment)
7. Patient using anticoagulants
8. Patients with congestive heart failure or angina unable to be controlled
9. Patients with malignant tumor requiring treatment
10. Pregnant or breast-feeding woman
11. Patient in whom physician decision is disqualificiation

Short vs long-term dual antiplatelet therapy
1. Patient with modified Rankin scale score of = 1
2. Patient with any procedural events
3. Patient who received stent-assisted coiling for fusiform or dissected aneurysm
4. Patient with side effects of aspirin or clopidogrel
5. Patient with underlying disease requiring continuous dual antiplatelet therapy over 12 months
6. Patient using anticoagulants
7. Patient with a high risk of stroke including arterial fibrillation, occlusion or stenosis of = 30% in extra- or intracranial artery, moyamoya disease, or arteriovenous malformation
8. Patient with a high possibility of active bleeding such as symptomatic intracranial hemorrhage or active gastric ulcer
9. Patient with bleeding tendency or coagulopathy
10. Patient with thrombocytopenia (< 100,000/mm3 of platelet count within three months before enrollment)
11. Patient with liver disease (> 100 of AST or ALT within 3 months before enrollment)
12. Patient with renal disease (> 2mg/dL of serum creatinine within 3 months before enrollment)
13. Patients with congestive heart failure or angina unable to be controlled
14. Patients in whom regular follow-up is unable
15. Patients with poor medical condition or life expectancy of less than 2 years
16. Pregnant or breast-feeding woman
17. Patient in whom physician decision is disqualification

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thromboembolic event

Secondary Outcome Measures

Name	Time	Method
nfavorable outcome;Bleeding event