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

NCT ID: NCT03620760

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

2036 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-07

Study Completion Date

2020-12-31

Brief Summary

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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

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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

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Unstable Angina Pectoris Coronary Stent Implantation

Keywords

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Unstable Angina Stent Ticagrelor Platelet aggregation Percutaneous Coronary Intervention Coronary Artery Disease Major Adverse Cardiovascular and Cerebrovascular Events Bleeding Events

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lower dose ticagrelor

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

Group Type EXPERIMENTAL

Ticagrelor 45 mg

Intervention Type DRUG

Ticagrelor (AZD6140) 45 mg twice daily dose

Aspirin

Intervention Type DRUG

Aspirin 100 mg once daily dose

Standard dose ticagrelor

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

Group Type ACTIVE_COMPARATOR

Ticagrelor 90 mg

Intervention Type DRUG

Ticagrelor (AZD6140) 90 mg twice daily dose

Aspirin

Intervention Type DRUG

Aspirin 100 mg once daily dose

Interventions

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Ticagrelor 90 mg

Ticagrelor (AZD6140) 90 mg twice daily dose

Intervention Type DRUG

Ticagrelor 45 mg

Ticagrelor (AZD6140) 45 mg twice daily dose

Intervention Type DRUG

Aspirin

Aspirin 100 mg once daily dose

Intervention Type DRUG

Other Intervention Names

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AZD6140 AZD6140

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiaofan Wu

OTHER

Sponsor Role lead

Responsible Party

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Xiaofan Wu

Chief Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiaofan Wu

Role: STUDY_DIRECTOR

Beijing Anzhen Hospital

Locations

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Xiaofan Wu

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaofan Wu, MD

Role: CONTACT

Phone: 13370103552

Email: [email protected]

Facility Contacts

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Xiaofan Wu, Master

Role: primary

Other Identifiers

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2018-2-1064

Identifier Type: -

Identifier Source: org_study_id