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

Xiaofan Wu

Status and phase: Unknown; Phase 4

Conditions: Coronary Stent Implantation; Unstable Angina Pectoris

Treatments: Drug: Ticagrelor 90 mg; Drug: Ticagrelor 45 mg; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT03620760

2018-2-1064

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,036 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients admission for coronary artery disease treatment with non-emergency percutaneous intervention with stent deployment
• 18 years≤age≤80 years
• Patients understands the study requirements and the treatment procedures and provided informed consent before the procedure

Exclusion criteria

• Allergy or intolerance to ticagrelor or aspirin
• Need for oral anticoagulation therapy
• Concomitant oral or intravenous therapy with strong inhibitors of Cytochrome P450, family 3, subfamily A (CYP3A), Substrates of CYP3A with narrow therapeutic indices or strong inducers of CYP3A
• Active bleeding, previous history of intracranial hemorrhage, gastrointestinal hemorrhage in the past 6 months and major operation within 30 days
• High risk of bradyarrhythmias
• Severe liver dysfunction and abnormal renal function
• Patient is a woman who is pregnant or nursing
• Unable or unwilling to give written informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,036 participants in 2 patient groups

Lower dose ticagrelor

Experimental group

Description:

Subjects will be treated with ticagrelor 45 mg twice daily in combination with aspirin 100mg once daily.

Treatment:

Drug: Ticagrelor 45 mg

Drug: Aspirin

Standard dose ticagrelor

Active Comparator group

Description:

Subjects will be treated with ticagrelor 90 mg twice daily in combination with aspirin 100mg once daily.

Treatment:

Drug: Ticagrelor 90 mg

Drug: Aspirin