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

NCT03823274 | Completed

• 1 other identifier: YMC037
• Study Type: observational
• Target: 1,011
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• evaluate the relationship of stroke recurrence and anti-platelet resitance

  To evaluate the relationship of stroke recurrence and anti-platelet resitance in ischemic stroke patients receiving aspirin 10mmg and clopidogrel 75mg for 12weeks

  12weeks

Interventions

Aspirin, Clopidogrel DRUG

to evaluate the relationship of stroke recurrence and anti-platelet resistance in ischemic stroke patients receiving aspirin and clopidogrel

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke patient

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Chungnam National University Hospital

Daejeon, South Korea

Location

Related Publications (1)

• Kim J, Shin BS, Kim DH, Shin DI, Ahn SH, Kim JG, Ryu SH, Moon HR, Kang HG, Jeong H, Yum KS, Chae HY, Kim DH, Kang K, Kim J. Molecular genomic and epigenomic characteristics related to aspirin and clopidogrel resistance. BMC Med Genomics. 2024 Jun 20;17(1):166. doi: 10.1186/s12920-024-01936-1.

  PMID: 38902747 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• jei Kim

  Chungnam National Universtity Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 30, 2019
• Study Start: April 1, 2019
• Primary Completion: January 3, 2022
• Study Completion: January 3, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

KR (1)