Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-24

Study Completion Date

2021-01-22

Brief Summary

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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

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Detailed Description

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Comparison between dual-antiplatelet and triple-platelet preparation

Conditions

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Aneurysm, Cerebral Endovascular Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Aspirin protect tablet

Prasugrel

Intervention Type DRUG

Prasugrel tablet

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.

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Aspirin protect tablet

Clopidogrel

Intervention Type DRUG

Clopidogrel 75mg tablet

Cilostazol

Intervention Type DRUG

Cilostazol tablet

Interventions

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Aspirin

Aspirin protect tablet

Intervention Type DRUG

Prasugrel

Prasugrel tablet

Intervention Type DRUG

Clopidogrel

Clopidogrel 75mg tablet

Intervention Type DRUG

Cilostazol

Cilostazol tablet

Intervention Type DRUG

Other Intervention Names

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Aspirin protect Effient Plavix Plavitor Pletaal Cilostan CR

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes