Myocardial InfarctionNCT05599152
Comparison of Myocardial Infarction Patients Who Were Prescribed a Novel Antiplatelet Agent or Clopidogrel
An observational study of Myocardial Infarction, run by Chan Joon Kim at 1 site in South Korea.
Trial summary
Myocardial infarction is defined according to icd-10 using the data base of South korea National Health Insurance Corporation, where personal identification information has already been removed, and detailed results are derived for each drug category. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 May 2020to Nov 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prognostic data of patients who maintained aspirin and ticagreolor/prasugrel as standard therapy in patients with acute myocardial infarction who underwent percutaneous coronary intervention, and patients with clopidogrel after early discontinuation of ticagrerol/prasugrel
Who may be able to join
- Patients who have a diagnosis code for acute myocardial infarction indicated in the National Health Insurance data and data for drugs that have used ticagrelor/prasugrel for 30-90 days when hospitalized for the relevant disease.
- Patients who switched to clopidogrel after 30-90 days.
- Patients with a diagnosis code for Venus myocardial infarction and a prescription code for percutaneous cardiovascular intervention in the National Health Insurance data.
- Adults 18 years of age or older
Who cannot join
- A person who has data for requesting blood transfusion during the period of hospitalization in the National Health Insurance data
- Those who have data for oral anticoagulants (warfarin, Coumadin, apixaban, edoxaban, dabigatran, rivaroxaban) in the National Health Insurance data
- Those who have a diagnosis code for malignant tumor in the National Health Insurance data
- Those who have end-stage renal failure code in the National Health Insurance data or those who have data for hemo/peritoneal dialysis
- A person who has a request for blood transfusion during the period of using Ticagrelor/prasugrel
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Uijeongbu-si, 11765
UMT
About this study
Official title: A Study of Clinical Outcomes in Patients With Myocardial Infarction Who Maintained Novel Antiplatelet Agents for 1 Year and Patients Who Switched to Clopidogrel Early
Myocardial infarction is defined according to icd-10 using the data base of South korea National Health Insurance Corporation, where personal identification information has already been removed, and detailed results are derived for each drug category.
Read the detailed description
The purpose of this study is to compare the prognosis of patients with clopidogrel after early discontinuation of ticagrelor/prasugrel with patients who maintained aspirin and ticagrelor/prasugrel as standard therapy in patients with acute myocardial infarction who underwent percutaneous coronary intervention.
- Conditions
- Myocardial Infarction
- Keywords
- clopidogrel, novel antiplatelet agent
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ticagrelor/prasugrel Group | Patients with acute myocardial infarction who underwent percutaneous coronary intervention and maintained aspirin and ticagrelor/prasugrel as standard therapy. | |
| clopidogrel Group | In patients with acute myocardial infarction who underwent percutaneous coronary intervention, discontinued ticagrelor/prasugrel and switched to clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause death, recurrent myocardial infarction, stroke, (ischemic and hemorrhagic ) and bleeding within one year.
compared patients who maintained ticagrelor/Prasugrel with those who switched from ticagrelor/prasugrel to clopidogrel.
- All cause death
- Myocardial infarction
- Stroke
- Bleeding
Categorical data is indicated by number (%) and analyzed by X2 statistics. Continuous variables are expressed as mean standard deviation (±SD) , and in the case of skewed distribution, comparison is made by Mann-Whitney test or Student t test. To balance differences in baseline characteristics, stabilized inverse probability of treatment weighting (sIPTW) is used. For further analysis, consider propensity score matching (PSM) with nearest neighbor method and standardized mortality ratio weighting (SMRW) estimation.
Propensity score uses a generalized additive logistic model and considers demographic data (age, gender, hypertension, diabetes mellitus, heart failure hemodialysis).
Measured: Percutaneous coronary intervention after 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start21 May 2020
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chan Joon Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical
- Responsible party
- Sponsor-investigator, Chan Joon Kim, Uijeongbu St. Mary Hospital
- Investigators
- Chan Joon Kim, Principal investigator, The Catholic University of Korea, Uijeongbu St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599152
- Sponsor's protocol ID
- CKD-HIRA-Data-Review
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Clinical Outcomes in Patients With Myocardial Infarction Who Maintained Novel Antiplatelet Agents for 1 Year and Patients Who Switched to Clopidogrel Early
- ClinicalTrials.gov ID
- NCT05599152
- Acronym / sponsor ID
- CKD-HIRA-Data-Review
- Conditions
- Myocardial Infarction
- Keywords
- clopidogrel, novel antiplatelet agent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Chan Joon KimUniversity, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical
- Study start
- 21 May 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 31 Oct 2022 (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.
Myocardial infarction is defined according to icd-10 using the data base of South korea National Health Insurance Corporation, where personal identification information has already been removed, and detailed results are derived for each drug category.
Detailed description
The purpose of this study is to compare the prognosis of patients with clopidogrel after early discontinuation of ticagrelor/prasugrel with patients who maintained aspirin and ticagrelor/prasugrel as standard therapy in patients with acute myocardial infarction who underwent percutaneous coronary intervention.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ticagrelor/prasugrel Group | – | –Patients with acute myocardial infarction who underwent percutaneous coronary intervention and maintained aspirin and ticagrelor/prasugrel as standard therapy. |
| clopidogrel Group | – | –In patients with acute myocardial infarction who underwent percutaneous coronary intervention, discontinued ticagrelor/prasugrel and switched to clopidogrel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prognostic data of patients who maintained aspirin and ticagreolor/prasugrel as standard therapy in patients with acute myocardial infarction who underwent percutaneous coronary intervention, and patients with clopidogrel after early discontinuation of ticagrerol/prasugrel
Key inclusion criteria (4 listed)
- Patients who have a diagnosis code for acute myocardial infarction indicated in the National Health Insurance data and data for drugs that have used ticagrelor/prasugrel for 30-90 days when hospitalized for the relevant disease.
- Patients who switched to clopidogrel after 30-90 days.
- Patients with a diagnosis code for Venus myocardial infarction and a prescription code for percutaneous cardiovascular intervention in the National Health Insurance data.
- Adults 18 years of age or older
Key exclusion criteria (5 listed)
- A person who has data for requesting blood transfusion during the period of hospitalization in the National Health Insurance data
- Those who have data for oral anticoagulants (warfarin, Coumadin, apixaban, edoxaban, dabigatran, rivaroxaban) in the National Health Insurance data
- Those who have a diagnosis code for malignant tumor in the National Health Insurance data
- Those who have end-stage renal failure code in the National Health Insurance data or those who have data for hemo/peritoneal dialysis
- A person who has a request for blood transfusion during the period of using Ticagrelor/prasugrel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite of all-cause death, recurrent myocardial infarction, stroke, (ischemic and hemorrhagic ) and bleeding within one year.
Time frame: Percutaneous coronary intervention after 1 Year
compared patients who maintained ticagrelor/Prasugrel with those who switched from ticagrelor/prasugrel to clopidogrel. * All cause death * Myocardial infarction * Stroke * Bleeding Categorical data is indicated by number (%) and analyzed by X2 statistics. Continuous variables are expressed as mean standard deviation (±SD) , and in the case of skewed distribution, comparison is made by Mann-Whitney test or Student t test. To balance differences in baseline characteristics, stabilized inverse probability of treatment weighting (sIPTW) is used. For further analysis, consider propensity score matching (PSM) with nearest neighbor method and standardized mortality ratio weighting (SMRW) estimation. Propensity score uses a generalized additive logistic model and considers demographic data (age, gender, hypertension, diabetes mellitus, heart failure hemodialysis).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
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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.
Chan Joon Kim principal investigator
The Catholic University of Korea, Uijeongbu St. Mary's 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 Myocardial Infarction, run by Chan Joon Kim 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact UMT aPM (010-8622-9502 ext. +82, kskim@e-umt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause death, recurrent myocardial infarction, stroke, (ischemic and hemorrhagic ) and bleeding within one year. (time frame: Percutaneous coronary intervention after 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2022.