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

Unstable Angina Pectoris Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03620760
• Other study ID #: 2018-2-1064
• Status: Recruiting
• Phase: Phase 4
• Start date: August 7, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2018
• Source: Beijing Anzhen Hospital
• Contact: Xiaofan Wu, MD
• Phone: 13370103552
• Email: drwuxf[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2036
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Unstable
• Coronary Stent Implantation
• Unstable Angina Pectoris

Intervention

Drug:
• Ticagrelor 90 mg
Ticagrelor (AZD6140) 90 mg twice daily dose
• Ticagrelor 45 mg
Ticagrelor (AZD6140) 45 mg twice daily dose
• Aspirin
Aspirin 100 mg once daily dose

Locations

Country	Name	City	State
China	Xiaofan Wu	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xiaofan Wu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PLATO-defined any minor bleeding event	To compare two intensities of ticagrelor therapy on minor bleeding event as any bleeding requiring medical intervention but not meeting the criteria for major bleeding. Events were adjudicated by an endpoint committee.	Randomization up to 24 months
Other	PLATO-defined any minimal bleeding event	To compare two intensities of ticagrelor therapy on minimal bleeding event as all other bleeding (eg, bruising, bleeding gums, oozing from injection site) not requiring intervention or treatment. Events were adjudicated by an endpoint committee.	Randomization up to 24 months
Other	Other adverse events	To compare two intensities of ticagrelor therapy on other adverse events including dyspnea or bradyarrhythmia. Events were adjudicated by an endpoint committee.	Randomization up to 24 months
Other	Experiment examination	To compare two intensities of ticagrelor therapy on increase of serum uric acid or creatinine. Events were adjudicated by an endpoint committee.	Randomization up to 24 months
Primary	Incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) and major bleeding event	Participants with death from vascular causes, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke. Intention to treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.; Participants with PLATO major bleeding event including fatal bleeding, intracranial bleeding, intrapericardial bleeding with cardiac tamponade, hypovolemic shock or severe hypotension due to bleeding and requiring pressures or surgery, a decline in the hemoglobin level of 5.0 g per deciliter or more, or the need for transfusion of at least. Events were adjudicated by an endpoint committee.	Randomization up to 24 months
Secondary	Any event from the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke	Participants with any event from the composite of cardiovascular death, non-fatal MI, stent thrombosis, coronary revascularization and stroke. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee.	Randomization up to 24 months
Secondary	All cause death	Participants with all cause death. ITT analysis of whole population. Events were adjudicated by an endpoint committee.	Randomization up to 24 months
Secondary	PLATO-defined any bleeding event	Participants with any other bleeding events (minor bleeding or minimal bleeding) as defined by the PLATO. Events were adjudicated by an endpoint committee.	Randomization up to 24 months