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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
Sponsored by
Xiaofan Wu
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
August 5, 2018
Last Updated
December 21, 2018
Sponsor
Xiaofan Wu
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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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

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
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.
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
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.
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
No
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
Email
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
No

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

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