Ticagrelor in Elderly Patients Undergoing Percutaneous Coronary Intervention

August 5, 2021 updated by: Meng Shaoke, The First Affiliated Hospital of Dalian Medical University

Antiplatelet Therapy 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1505

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Dalian, China, 116011
        • The First Affiliated Hospital of Dalian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients ≥75 years of age who were treated with PCI (limited to stent implantation) at the First Affiliated Hospital of Dalian Medical University from January 1, 2015 to December 31, 2019 were screened for additional enrollment criteria.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Types 2, 3, and 5 bleeding, as defined by the Bleeding Academic Research Consortium
Time Frame: 12 months
The primary safety endpoint
12 months
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Myocardial infarction
Time Frame: 12 months
12 months
All-cause mortality
Time Frame: 12 months
12 months
Revascularization
Time Frame: 12 months
12 months
Ischemic stroke
Time Frame: 12 months
12 months
Incidence of BARC3 and 5 bleeding
Time Frame: 12 months
12 months
Incidence of major and minor bleeding defined by the PLATO study
Time Frame: 12 months
12 months
Incidence of major and minor bleeding defined by the TIMI study
Time Frame: 12 months
12 months
Occurrence of any bleeding
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Dalian Medical University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2021

Primary Completion (Actual)

August 5, 2021

Study Completion (Actual)

August 6, 2021

Study Registration Dates

First Submitted

August 5, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 10, 2021

Study Record Updates

Last Update Posted (Actual)

August 10, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PJ-KS-KY-2021-146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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