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Completed

NCT Number: NCT03581409

Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm

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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Key information

Conditions

Aneurysm, Cerebral Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Endovascular Procedures Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National Univeristy Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

Comparison between dual-antiplatelet and triple-platelet preparation

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

Aspirin protect tablet

Other names: Aspirin protect

Prasugrel

Drug

Prasugrel tablet

Other names: Effient

clopidogrel

Drug

Clopidogrel 75mg tablet

Other names: Plavix, Plavitor

Cilostazol

Drug

Cilostazol tablet

Other names: Pletaal, Cilostan CR

Primary outcomes

  1. Incidence of hemorrhagic complications between 2 arms

    Time frame: through study completion (for 3 months)

    check minor and major hemorrhagic complications of intra- and post-procedures

Secondary outcomes

  1. Change of the level of P2Y12

    Time frame: through study completion (for 3 months)

    Check the change of the level of P2Y12 according to each arms during study periods

  2. mortality between 2 arms

    Time frame: through study completion (for 3 months)

    check mortality after procedures

  3. Incidence of thromboembolic complications between 2 arms

    Time frame: through study completion (for 3 months)

    check minor and major thromboembolic complications of intra- and post-procedures

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University Bundang Hospital

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 10, 2018
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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