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

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiaofan Wu
• Treatments: Adenosine; Aspirin; Ticagrelor

Criteria

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