Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03581409

Collaborator

Seoul National University Bundang Hospital (Other)

198

Enrollment

Location

Arms

Actual Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aneurysm, Cerebral Endovascular Procedures	Drug: Aspirin Drug: Prasugrel Drug: Clopidogrel Drug: Cilostazol	Phase 4

Detailed Description

Comparison between dual-antiplatelet and triple-platelet preparation

Study Design

Study Type:

Interventional

Actual Enrollment :

198 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 24, 2018

Actual Primary Completion Date :

Jan 22, 2021

Actual Study Completion Date :

Jan 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dual-antiplatelet 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 Aspirin protect tablet Other Names: Aspirin protect Drug: Prasugrel Prasugrel tablet Other Names: Effient
Experimental: triple-antiplatelet 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 Aspirin protect tablet Other Names: Aspirin protect Drug: Clopidogrel Clopidogrel 75mg tablet Other Names: Plavix Plavitor Drug: Cilostazol Cilostazol tablet Other Names: Pletaal Cilostan CR

Arm

Intervention/Treatment

Experimental: dual-antiplatelet

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

Aspirin protect tablet

Other Names:

Aspirin protect

Drug: Prasugrel

Prasugrel tablet

Other Names:

Effient

Experimental: triple-antiplatelet

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

Aspirin protect tablet

Other Names:

Aspirin protect

Drug: Clopidogrel

Clopidogrel 75mg tablet

Other Names:

Plavix

Plavitor

Drug: Cilostazol

Cilostazol tablet

Other Names:

Pletaal

Cilostan CR

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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