Ischemic StrokeNCT03823274
Multi-center, Prospective, Cohort Study to Evaluate the Relationship of Stroke Recurrence and Anti-platelet Resistance in Ischemic Stroke Patients
An observational study of Ischemic Stroke, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
This cohort study will evaluate the relatiobship of stroke recurrence and anti-platelet resistance in ischemic stroke patients Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Aspirin, Clopidogrel
- How many people
- 1,011 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2019to 3 Jan 2022
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patient
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This cohort study will evaluate the relatiobship of stroke recurrence and anti-platelet resistance in ischemic stroke patients
- Conditions
- Ischemic Stroke
- Being tested
- Aspirin, Clopidogrel
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin, ClopidogrelDrug
to evaluate the relationship of stroke recurrence and anti-platelet resistance in ischemic stroke patients receiving aspirin and clopidogrel
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Apr 2019
- Primary completion3 Jan 2022
- Study completion3 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,011 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- jei Kim, Principal investigator, Chungnam National Universtity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823274
- Sponsor's protocol ID
- YMC037
- Status last verified
- Oct 2022
- First submitted
- 24 Jan 2019
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38902747
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective, Cohort Study to Evaluate the Relationship of Stroke Recurrence and Anti-platelet Resistance in Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT03823274
- Acronym / sponsor ID
- YMC037
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,011 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cohort study will evaluate the relatiobship of stroke recurrence and anti-platelet resistance in ischemic stroke patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patient
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin, Clopidogrelto evaluate the relationship of stroke recurrence and anti-platelet resistance in ischemic stroke patients receiving aspirin and clopidogrel | Drug | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Derived from this study: PubMed 38902747Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jei Kim principal investigator
Chungnam National Universtity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Yuhan Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the relationship of stroke recurrence and anti-platelet resitance (time frame: 12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03823274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.