Aneurysm, Cerebral, Endovascular Procedures
Conditions
Keywords
antiplatelet preparation, cerebral aneurysm, coil embolization
Brief summary
Perform a randomized comparison study of dual-antiplatelet (aspirin, prasugrel) and triple-antiplatelet (aspirin, clopidogrel, and cilostazol) preparation using P2Y12 assay in patients with high on-treatment platelet reactivity undergoing stent-assisted coil embolization for an unruptured intracranial aneurysm
Detailed description
Comparison between dual-antiplatelet and triple-platelet preparation
Interventions
DRUGAspirin
Aspirin protect tablet
DRUGPrasugrel
Prasugrel tablet
DRUGClopidogrel
Clopidogrel 75mg tablet
DRUGCilostazol
Cilostazol tablet
Sponsors
Seoul National University Bundang Hospital
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* patients with clopidogrel resistance (greater than 220 P2Y12 reaction units using VerifyNow) * patients with unruptured intracranial aneurysms * patients over 20 years old * patients who can communicate with each other * patients who agreed to this study (with informed consent)
Exclusion criteria
* patients with recurrent aneurysms after coiling or clipping * patients with allergic reaction to antiplatelets * patients with high risks of hemorrhage * patients with coagulopathy * patients with thrombocytopenia (\<100,000/mm3) * patients with liver disease (\> 100 of aspartate aminotransferase or alanine aminotransferase) * patients with renal disease (\> 2mg/dL of serum creatinine) * patients with uncontrolled heart failure or angina * patients with malignant tumor * pregnant patients * patients with past history that may associated with headache, including subarachnoid hemorrhage, head trauma, intracerebral hemorrhage, trigeminal neuralgia, arteriovenous malformation, brain tumor) * Patients who are determined to be disqualified by researchers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hemorrhagic complications between 2 arms | through study completion (for 3 months) | check minor and major hemorrhagic complications of intra- and post-procedures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of the level of P2Y12 | through study completion (for 3 months) | Check the change of the level of P2Y12 according to each arms during study periods |
| mortality between 2 arms | through study completion (for 3 months) | check mortality after procedures |
| Incidence of thromboembolic complications between 2 arms | through study completion (for 3 months) | check minor and major thromboembolic complications of intra- and post-procedures |
Countries
South Korea
Outcome results
None listed