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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823274
• Other study ID #: YMC037
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: January 3, 2022

Study information

• Verified date: October 2022
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1011
• Est. completion date: January 3, 2022
• Est. primary completion date: January 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Recurrence
• Stroke

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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