NCT03620760

Efficacy and Safety of Low Dose Ticagrelor in Patients With Unstable Angina Pectoris After Coronary Stent Implantation

A Prospective, Randomised, Open-labeled, Parallel Group Study to Assess the Efficacy and Safety of Low Dose Ticagrelor Compared With Standard Dose Ticagrelor in Patients With Unstable Angina Pectoris After Drug Eluting Stent Implantation

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,036 (estimated)
• Sponsor: Xiaofan Wu · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study is to evaluate efficacy and safety of low dose of ticagrelor therapy for Chinese unstable angina patients treated with non-urgent coronary stent implantation, to examine whether lower dose ticagrelor (45 mg twice-daily) is not inferior to standard dose (90 mg twice-daily) for the prevention of major adverse cardiovascular and cerebrovascular events, as well as will reduce the incidence of bleeding during long-term treatment.

Detailed description

This is a prospective, single center, randomized, parallel-group trial designed to evaluate the efficacy and safety of low dose ticagrelor on a background of aspirin for patients treated with non-urgent coronary stent implantation. 2036 subjects will be enrolled. All patients will receive treatment with aspirin and a P2Y12 inhibitor for 3 months after the index procedure. At 3 months, eligible patients were then randomly assigned in a 1:1 ratio to receive a standard dose ticagrelor 90 mg bid or a lower dose ticagrelor 45 mg bid in addition to aspirin 100mg. The primary efficacy end points are the event rate of the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke at 24 months. The primary safety end point is the incidence of PLATO major bleeding at 24 months.

Conditions

• Unstable Angina Pectoris
• Coronary Stent Implantation

Interventions

Type	Name	Description
DRUG	Ticagrelor 90 mg	Ticagrelor (AZD6140) 90 mg twice daily dose
DRUG	Ticagrelor 45 mg	Ticagrelor (AZD6140) 45 mg twice daily dose
DRUG	Aspirin	Aspirin 100 mg once daily dose

Timeline

• Start date: 2018-08-07
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-08-08
• Last updated: 2018-12-24

Locations

1 site across 1 country: China