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Trial record 6 of 510 for:    ASPIRIN AND P2

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03581409
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE June 14, 2018
First Posted Date  ICMJE July 10, 2018
Last Update Posted Date October 11, 2019
Actual Study Start Date  ICMJE October 24, 2018
Estimated Primary Completion Date October 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2018)
Incidence of hemorrhagic complications between 2 arms [ Time Frame: through study completion (for 3 months) ]
check minor and major hemorrhagic complications after procedures
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03581409 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2018)
  • 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
  • Incidence of thromboembolic complications between 2 arms [ Time Frame: through study completion (for 3 months) ]
    check minor and major thromboembolic complications after procedures
  • mortality between 2 arms [ Time Frame: through study completion (for 3 months) ]
    check mortality after procedures
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aneurysm, Cerebral
  • Endovascular Procedures
Intervention  ICMJE
  • Drug: Aspirin
    Aspirin protect tablet
    Other Name: Aspirin protect
  • Drug: Prasugrel
    Prasugrel tablet
    Other Name: Effient
  • Drug: Clopidogrel
    Clopidogrel 75mg tablet
    Other Names:
    • Plavix
    • Plavitor
  • Drug: Cilostazol
    Cilostazol tablet
    Other Names:
    • Pletaal
    • Cilostan CR
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Aspirin
    • Drug: Prasugrel
  • 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.
    Interventions:
    • Drug: Aspirin
    • Drug: Clopidogrel
    • Drug: Cilostazol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2018)
176
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 11, 2020
Estimated Primary Completion Date October 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Seung Pil Ban, M.D. 82-31-787-7175 neurosurgeryban@gmail.com
Contact: O-Ki Kwon, M.D., Ph.D. 82-31-787-7163 meurokwonoki@gmail.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03581409
Other Study ID Numbers  ICMJE B-1712/439-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Seoul National University Bundang Hospital
Investigators  ICMJE
Study Chair: Seung Pil Ban, M.D. Seoul National Bundang Hospital
PRS Account Seoul National University Hospital
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP