Ticagrelor in Elderly Patients Undergoing Percutaneous Coronary Intervention

Completed

• Conditions: Platelet Aggregation Inhibitors; Aged; Percutaneous Coronary Intervention; Dual Anti-Platelet Therapy
• Interventions: Drug: Ticagrelor

• Registration Number: NCT04999293
• Lead Sponsor: The First Affiliated Hospital of Dalian Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-20
• Status Verified: 2021-08
• Primary Completion: 2021-08-05
• Study First Submitted: 2021-08-05
• Study First Submitted QC: 2021-08-05
• Last Update Submitted: 2021-08-05
• Study Completion: 2021-08-06
• Study First Posted: 2021-08-10
• Last Update Posted: 2021-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1505

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;

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The Elderly Undergoing Percutaneous Coronary Intervention	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.

Primary Outcome Measures

Name	Time	Method
Types 2, 3, and 5 bleeding, as defined by the Bleeding Academic Research Consortium	12 months	The primary safety endpoint
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

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, China