Clinical trial NCT03620760: Efficacy and Safety of Low Dose Ticagrelor in Patients With Unstable Angina Pectoris After Coronary Stent Implantation
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Unstable Angina Pectoris
Coronary Stent Implantation
Keywords: Unstable Angina
Stent
Ticagrelor
Platelet aggregation
Percutaneous Coronary Intervention
Coronary Artery Disease
Major Adverse Cardiovascular and Cerebrovascular Events
Bleeding Events
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 2036
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients were randomly assigned in a 1:1 ratio to receive ticagrelor 90 mg twice daily plus aspirin 100mg once daily or ticagrelor 45 mg twice daily plus aspirin 100mg once daily.
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) and major bleeding event
timeFrame: Randomization up to 24 months
Secondary outcomes:
measure: Any event from the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke
timeFrame: Randomization up to 24 months
measure: All cause death
timeFrame: Randomization up to 24 months
measure: PLATO-defined any bleeding event
timeFrame: Randomization up to 24 months
Other outcomes:
measure: PLATO-defined any minor bleeding event
timeFrame: Randomization up to 24 months
measure: PLATO-defined any minimal bleeding event
timeFrame: Randomization up to 24 months
measure: Other adverse events
timeFrame: Randomization up to 24 months
measure: Experiment examination
timeFrame: Randomization up to 24 months
Locations:
city: Beijing
country: China
facility: Xiaofan Wu
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Xiaofan Wu
role: STUDY_DIRECTOR
References: