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Multi-center, Prospective, Cohort Study to Evaluate the Relationship of Stroke Recurrence and Anti-platelet Resistance in Ischemic Stroke Patients

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ClinicalTrials.gov Identifier: NCT03823274
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

Brief Summary:
This cohort study will evaluate the relatiobship of stroke recurrence and anti-platelet resistance in ischemic stroke patients

Condition or disease Intervention/treatment
Ischemic Stroke Drug: Aspirin, Clopidogrel

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Weeks
Official Title: Multi-center, Prospective, Cohort Study to Evaluate the Relationship of Stroke Recurrence and Anti-platelet Resistance in Ischemic Stroke Patients
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Aspirin, Clopidogrel
    to evaluate the relationship of stroke recurrence and anti-platelet resistance in ischemic stroke patients receiving aspirin and clopidogrel


Primary Outcome Measures :
  1. evaluate the relationship of stroke recurrence and anti-platelet resitance [ Time Frame: 12weeks ]
    To evaluate the relationship of stroke recurrence and anti-platelet resitance in ischemic stroke patients receiving aspirin 10mmg and clopidogrel 75mg for 12weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stroke patient
Criteria

Inclusion Criteria:

  1. Men and women over 60 years old at the time of written consent
  2. Those admitted to the hospital within 72 hours after acute cerebral infarction and treated with Aspirin 100 mg and Clopidogrel 75 mg
  3. Written informed consent voluntarily signed

Exclusion Criteria:

  1. Those with evidence other brain lesions such as brain tumors
  2. Those who need oral anticoagulants other than vitamin K antagonists or anticoagulant therapy of warfarin
  3. Contraindicate to Aspirin or Clopidogrel or allergic to the drug
  4. Subjects who are at risk of active pathological bleeding such as digestive ulcer and intracranial hemorrhage
  5. Cancer disease that can shorten life expectancy
  6. Patient's condition that may interfere with participation in study such as mental illness, mental retardation, dementia, drug abuse, and alcoholism
  7. Subjects other than the above unsuitable for this clinical study identified by Investigator

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): NCT03823274


Contacts
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Contact: Jei Kim 42-280-7805 ext 82 jeikim@cnu.ac.kr

Locations
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Korea, Republic of
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Jei Kim    42-252-8654 ext 82    jeikim@cnu.ac.kr   
Sponsors and Collaborators
Yuhan Corporation
Investigators
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Principal Investigator: jei Kim Chungnam National Universtity Hospital

Additional Information:

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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT03823274     History of Changes
Other Study ID Numbers: YMC037
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Stroke
Ischemia
Recurrence
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes
Brain Infarction
Brain Ischemia
Aspirin
Clopidogrel
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
Cyclooxygenase Inhibitors
Enzyme Inhibitors