Clinical trial NCT05599152: Comparison of Myocardial Infarction Patients Who Were Prescribed a Novel Antiplatelet Agent or Clopidogrel
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Keywords: clopidogrel
novel antiplatelet agent
Lead sponsor: Uijeongbu St. Mary Hospital
Sponsor class: OTHER
Collaborators: name: Chong Kun Dang Pharmaceutical
First posted: 2022-10-31
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Composite of all-cause death, recurrent myocardial infarction, stroke, (ischemic and hemorrhagic ) and bleeding within one year.
timeFrame: Percutaneous coronary intervention after 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
name: Chan Joon Kim
role: PRINCIPAL_INVESTIGATOR
References: