Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm

Study Overview
=================
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

Official Title
-----------------
Comparison of Dual-Antiplatelet and Triple-Antiplatelet Preparation Using P2Y12 Assay in Patients With High On-Treatment Platelet Reactivity Undergoing Stent-Assisted Coil Embolization for An Unruptured Intracranial Aneurysm

Conditions
-----------------
Aneurysm, Cerebral, Endovascular Procedures

Intervention / Treatment
-----------------
* Drug: Aspirin
* Drug: Prasugrel
* Drug: Clopidogrel
* Drug: Cilostazol


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dual-antiplatelet<br>Patients with unruptured aneurysms received dual antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel) for at least five days before embolization. One day prior to coil embolization, P2Y12 reaction units were measured using VerifyNow. Patients with clopidogrel resistance (greater than 220 PRU) received prasugrel 20mg. After that, dual-antiplatelet (aspirin 100mg & prasugrel 5mg) treatment continued for 3 months through study completion. | Drug: Aspirin<br>* Aspirin protect tablet<br>* Other names: Aspirin protect;Drug: Prasugrel<br>* Prasugrel tablet<br>* Other names: Effient;|
| Experimental: triple-antiplatelet<br>Patients with unruptured aneurysms received dual antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel) for at least five days before embolization. One day prior to coil embolization, P2Y12 reaction units (PRU) were measured using VerifyNow. Patients with clopidogrel resistance (greater than 220 PRU) received cilostazol 200mg. After that, triple-antiplatelet (aspirin 100mg, clopidogrel 75mg, and cilostazol 200mg) treatment continued for 3 months through study completion. | Drug: Aspirin<br>* Aspirin protect tablet<br>* Other names: Aspirin protect;Drug: Clopidogrel<br>* Clopidogrel 75mg tablet<br>* Other names: Plavitor;Drug: Cilostazol<br>* Cilostazol tablet<br>* Other names: Cilostan CR;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hemorrhagic complications between 2 arms | check minor and major hemorrhagic complications of intra- and post-procedures | through study completion (for 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the level of P2Y12 | Check the change of the level of P2Y12 according to each arms during study periods | through study completion (for 3 months) | 
| mortality between 2 arms | check mortality after procedures | through study completion (for 3 months) | 
| Incidence of thromboembolic complications between 2 arms | check minor and major thromboembolic complications of intra- and post-procedures | through study completion (for 3 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antiplatelet preparation, cerebral aneurysm, coil embolization