Comparison of Myocardial Infarction Patients Who Were Prescribed a Novel Antiplatelet Agent or Clopidogrel
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
1 other identifier
observational
3,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2020
CompletedFirst Submitted
Initial submission to the registry
October 25, 2022
CompletedFirst Posted
Study publicly available on registry
October 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedOctober 31, 2022
October 1, 2022
2.4 years
October 25, 2022
October 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Percutaneous coronary intervention after 1 Year
Study Arms (2)
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
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chan Joon Kimlead
- Chong Kun Dang Pharmaceuticalcollaborator
Study Sites (1)
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Uijeongbu-si, 11765, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chan Joon Kim
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
October 25, 2022
First Posted
October 31, 2022
Study Start
May 21, 2020
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
October 31, 2022
Record last verified: 2022-10