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Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03581409
Recruitment Status : Completed
First Posted : July 10, 2018
Last Update Posted : March 18, 2021
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Seoul National University Hospital

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : October 24, 2018
Actual Primary Completion Date : January 22, 2021
Actual Study Completion Date : January 22, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Aspirin protect

Drug: Prasugrel
Prasugrel tablet
Other Name: 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 Name: Aspirin protect

Drug: Clopidogrel
Clopidogrel 75mg tablet
Other Names:
  • Plavix
  • Plavitor

Drug: Cilostazol
Cilostazol tablet
Other Names:
  • Pletaal
  • Cilostan CR


Outcome Measures
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Primary Outcome Measures :
  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

  2. 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


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581409


Locations
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Korea, Republic of
Seoul National Univeristy Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Investigators
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Study Chair: Seung Pil Ban, M.D. Seoul National Bundang Hospital
More Information
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Publications of Results:

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03581409    
Other Study ID Numbers: B-1712/439-001
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Seoul National University Hospital:
antiplatelet preparation
cerebral aneurysm
coil embolization
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Aspirin
Cilostazol
Clopidogrel
Prasugrel Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists