Comparison of Myocardial Infarction Patients Who Were Prescribed a Novel Antiplatelet Agent or Clopidogrel

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599152
• Other study ID #: CKD-HIRA-Data-Review
• Status: Recruiting
• Start date: May 21, 2020
• Est. completion date: November 2022

Study information

• Verified date: October 2022
• Source: Uijeongbu St. Mary Hospital
• Contact: UMT aPM
• Phone: 010-8622-9502
• Email: kskim[@]e-umt.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, Uijeongbu ST. Mary's Hospital	Uijeongbu

Sponsors (2)

Lead Sponsor	Collaborator
Chan Joon Kim	Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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