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

Primary Purpose

Unstable Angina Pectoris, Coronary Stent Implantation

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Ticagrelor 90 mg

Ticagrelor 45 mg

Aspirin

About this trial

This is an interventional treatment trial for Unstable Angina Pectoris focused on measuring Unstable Angina, Stent, Ticagrelor, Platelet aggregation, Percutaneous Coronary Intervention, Coronary Artery Disease, Major Adverse Cardiovascular and Cerebrovascular Events, Bleeding Events

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Xiaofan WuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lower dose ticagrelor

Standard dose ticagrelor

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

All cause death

Participants with all cause death. ITT analysis of whole population. Events were adjudicated by an endpoint committee.

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.

Full Information

NCT ID

NCT03620760

First Posted

August 5, 2018

Last Updated

December 21, 2018

Sponsor

Xiaofan Wu

1. Study Identification

Unique Protocol Identification Number

NCT03620760

Brief Title

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

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 7, 2018 (Actual)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xiaofan Wu

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2036 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lower dose ticagrelor

Arm Type

Experimental

Arm Description

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

Arm Title

Standard dose ticagrelor

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ticagrelor 90 mg

Other Intervention Name(s)

AZD6140

Intervention Description

Ticagrelor (AZD6140) 90 mg twice daily dose

Intervention Type

Drug

Intervention Name(s)

Ticagrelor 45 mg

Other Intervention Name(s)

AZD6140

Intervention Description

Ticagrelor (AZD6140) 45 mg twice daily dose

Intervention Type

Drug

Intervention Name(s)

Aspirin

Intervention Description

Aspirin 100 mg once daily dose

Primary Outcome Measure Information:

Title

Incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) and major bleeding event

Description

Time Frame

Randomization up to 24 months

Secondary Outcome Measure Information:

Title

Any event from the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke

Description

Time Frame

Randomization up to 24 months

Title

All cause death

Description

Participants with all cause death. ITT analysis of whole population. Events were adjudicated by an endpoint committee.

Time Frame

Randomization up to 24 months

Title

PLATO-defined any bleeding event

Description

Participants with any other bleeding events (minor bleeding or minimal bleeding) as defined by the PLATO. Events were adjudicated by an endpoint committee.

Time Frame

Randomization up to 24 months

Other Pre-specified Outcome Measures:

Title

PLATO-defined any minor bleeding event

Description

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.

Time Frame

Randomization up to 24 months

Title

PLATO-defined any minimal bleeding event

Description

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.

Time Frame

Randomization up to 24 months

Title

Other adverse events

Description

To compare two intensities of ticagrelor therapy on other adverse events including dyspnea or bradyarrhythmia. Events were adjudicated by an endpoint committee.

Time Frame

Randomization up to 24 months

Title

Experiment examination

Description

To compare two intensities of ticagrelor therapy on increase of serum uric acid or creatinine. Events were adjudicated by an endpoint committee.

Time Frame

Randomization up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaofan Wu, MD

Phone

13370103552

drwuxf@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaofan Wu

Organizational Affiliation

Beijing Anzhen Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Xiaofan Wu

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100029

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaofan Wu, Master

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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