Ticagrelor in Elderly Patients Undergoing Percutaneous Coronary Intervention

Sponsor
The First Affiliated Hospital of Dalian Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04999293
Collaborator
(none)
1,505
1
17
2694.6

Study Details

Study Description

Brief Summary

The study is an investigator-sponsored, retrospective cohort study designed to compare efficacy and safety of ticagrelor in elderly patients undergoing percutaneous coronary intervention.

Study Design

Study Type:
Observational
Actual Enrollment :
1505 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Antiplatelet Therapy in Elderly Patients Undergoing Percutaneous Coronary Intervention
Actual Study Start Date :
Jul 20, 2021
Actual Primary Completion Date :
Aug 5, 2021
Actual Study Completion Date :
Aug 6, 2021

Arms and Interventions

Arm Intervention/Treatment
The Elderly Undergoing Percutaneous Coronary Intervention

Patients were survivors and treated with DAPT (aspirin [100 mg once daily], cilostazol, or indobufen)combined with a P2Y12 receptor antagonist [clopidogrel (75 mg once daily) or ticagrelor (90 mg twice daily)]) at the time of hospital discharge.All patients were followed for 1 year in the outpatient clinic after hospital discharge.

Drug: Ticagrelor
Patients were survivors and treated with DAPT (aspirin [100 mg once daily], cilostazol, or indobufen)combined with a P2Y12 receptor antagonist [clopidogrel (75 mg once daily) or ticagrelor (90 mg twice daily)]) at the time of hospital discharge.All patients were followed for 1 year in the outpatient clinic after hospital discharge.
Other Names:
  • Clopidogrel
  • Outcome Measures

    Primary Outcome Measures

    1. Types 2, 3, and 5 bleeding, as defined by the Bleeding Academic Research Consortium [12 months]

      The primary safety endpoint

    2. Combined major adverse cardiovascular and cerebrovascular events (MACCEs), including all-cause mortality, myocardial infarction, ischemic stroke, and any revascularization. [12 months]

      The primary efficacy endpoint

    Secondary Outcome Measures

    1. All-cause mortality [12 months]

    2. Myocardial infarction [12 months]

    3. Revascularization [12 months]

    4. Ischemic stroke [12 months]

    5. Incidence of BARC3 and 5 bleeding [12 months]

    6. Incidence of major and minor bleeding defined by the PLATO study [12 months]

    7. Incidence of major and minor bleeding defined by the TIMI study [12 months]

    8. Occurrence of any bleeding [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age≥75 years old;

    • Treated with PCI (limited to stent implantation) ;

    • Survivors and treated with DAPT (aspirin [100 mg once daily], cilostazol, or indobufen)combined with a P2Y12 receptor antagonist [clopidogrel (75 mg once daily) or ticagrelor (90 mg twice daily)]) at discharge;

    Exclusion Criteria:
    • Coronary artery bypass graft (CABG) or only drug conservative treatment during hospitalization;

    • Concurrent use of oral anticoagulants;

    • Inability to tolerate long-term antiplatelet therapy, such as active bleeding and a bleeding tendency;

    • Acute infectious diseases;

    • Cognitive impairment;

    • Declined re-examination.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of Dalian Medical University Dalian China 116011

    Sponsors and Collaborators

    • The First Affiliated Hospital of Dalian Medical University

    Investigators

    • Principal Investigator: Shaoke Meng, MD, The First Affiliated Hospital of Dalian Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Meng Shaoke, M.D., The First Affiliated Hospital of Dalian Medical University
    ClinicalTrials.gov Identifier:
    NCT04999293
    Other Study ID Numbers:
    • PJ-KS-KY-2021-146
    First Posted:
    Aug 10, 2021
    Last Update Posted:
    Aug 10, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 10, 2021