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Completed

NCT Number: NCT04999293

Ticagrelor in Elderly Patients Undergoing Percutaneous Coronary Intervention

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

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Key information

Conditions

Platelet Aggregation Inhibitors Aged Dual Anti-Platelet Therapy Percutaneous Coronary Intervention

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Dalian Medical University

Dalian, 116011, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ticagrelor

Drug

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

Primary outcomes

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

    Time frame: 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.

    Time frame: 12 months

    The primary efficacy endpoint

Secondary outcomes

  1. All-cause mortality

    Time frame: 12 months

  2. Myocardial infarction

    Time frame: 12 months

  3. Revascularization

    Time frame: 12 months

  4. Ischemic stroke

    Time frame: 12 months

  5. Incidence of BARC3 and 5 bleeding

    Time frame: 12 months

  6. Incidence of major and minor bleeding defined by the PLATO study

    Time frame: 12 months

  7. Incidence of major and minor bleeding defined by the TIMI study

    Time frame: 12 months

  8. Occurrence of any bleeding

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Dalian Medical University

Other

Registry information

Official study title

Antiplatelet Therapy in Elderly Patients Undergoing Percutaneous Coronary Intervention

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 10, 2021
Registry last updated
Aug 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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