NCT05599152

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

2.4 years

First QC Date

October 25, 2022

Last Update Submit

October 25, 2022

Conditions

Keywords

clopidogrelnovel antiplatelet agent

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

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

Study Sites (1)

The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

Uijeongbu-si, 11765, South Korea

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Chan Joon Kim

    The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

    PRINCIPAL INVESTIGATOR

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

Locations