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Trial record 22 of 292 for:    ASPIRIN AND clopidogrel AND dual

Comparison of Two Different Antiplatelet Preparations for an Unruptured Intracranial Aneurysm

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ClinicalTrials.gov Identifier: NCT03581409
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : November 30, 2018
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Seoul National University Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 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
Estimated Primary Completion Date : June 11, 2019
Estimated Study Completion Date : July 11, 2019

Resource links provided by the National Library of Medicine


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




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 after 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. Incidence of thromboembolic complications between 2 arms [ Time Frame: through study completion (for 3 months) ]
    check minor and major thromboembolic complications after procedures

  3. mortality between 2 arms [ Time Frame: through study completion (for 3 months) ]
    check mortality after procedures



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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

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


Contacts
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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

Locations
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Korea, Republic of
Seoul National Univeristy Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
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   
Sub-Investigator: Tackeun Kim, M.D.         
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

Publications of Results:
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03581409     History of Changes
Other Study ID Numbers: B-1712/439-001
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: June 2018
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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Aspirin
Clopidogrel
Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cilostazol
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