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Low-dose Ticagrelor in Chinese ACS Patients Undergoing PCI

Primary Purpose

Acute Coronary Syndrome

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
half-dose ticagrelor
standard-dose ticagrelor
Sponsored by
First Affiliated Hospital of Harbin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • After half-dose ticagrelor (loading dose 90mg, and then 45mg bidpo.) treatment for 3 days, the platelet aggregation is effectively inhibited by light transmission aggregometry method and thromboela-stogram.
  • planned to undergo PCI recently
  • planned to DAPT for 1 year after PCI

Exclusion Criteria:

  • taken adenosine diphosphate (ADP) receptor antagonists within 2 weeks
  • Platelet count <100g/L;
  • A history of bleeding tendency;
  • Aspirin, ticagrelor or clopidogrel allergies;
  • Severe liver injury.

Sites / Locations

  • Thromboela-StogramRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

half-dose ticagrelor

standard-dose ticagrelor

Arm Description

Outcomes

Primary Outcome Measures

thromboela-stogram
inhibition of platelet aggregation (ADP) ; MA (ADP)
thromboela-stogram
inhibition of platelet aggregation; MA

Secondary Outcome Measures

MACE
cardiovascular death, non-fatal myocardial infarction and stroke
Side effects including bleeding and dyspnea
The rate of treatment interruption due to ticagrelor intolerance.

Full Information

First Posted
December 14, 2017
Last Updated
September 10, 2018
Sponsor
First Affiliated Hospital of Harbin Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03381755
Brief Title
Low-dose Ticagrelor in Chinese ACS Patients Undergoing PCI
Official Title
Comparative Effectiveness and Safety Analysis of Low-dose and Standard-dose Ticagrelor in Chinese Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 14, 2019 (Anticipated)
Study Completion Date
December 14, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Harbin Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Dual Antiplatelet Therapy (DAPT) with aspirin and P2Y12 receptor inhibitor remains a cornerstone in the secondary prevention of coronary artery disease (CAD). Clopidogrel is one of the most commonly used antithrombotic agent that inhibits the platelet P2Y(12) adenosine diphosphate (ADP) receptor. Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients. The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. One-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in Chinese patients with stable CAD. But the effectiveness and safety of low-dose ticagrelor remain yet not very clearly in Chinese patients with acute coronary syndrome undergoing percutaneous coronary intervention.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
half-dose ticagrelor
Arm Type
Experimental
Arm Title
standard-dose ticagrelor
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
half-dose ticagrelor
Intervention Description
To observe the effectiveness and safety of ticagrelor 45mg bidpo. in Chinese ACS patients undergoing PCI.
Intervention Type
Drug
Intervention Name(s)
standard-dose ticagrelor
Intervention Description
To observe the effectiveness and safety of ticagrelor 90mg bidpo. in Chinese ACS patients undergoing PCI.
Primary Outcome Measure Information:
Title
thromboela-stogram
Description
inhibition of platelet aggregation (ADP) ; MA (ADP)
Time Frame
up to 6 months
Title
thromboela-stogram
Description
inhibition of platelet aggregation; MA
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
MACE
Description
cardiovascular death, non-fatal myocardial infarction and stroke
Time Frame
up to 1 year
Title
Side effects including bleeding and dyspnea
Time Frame
up to 1 year
Title
The rate of treatment interruption due to ticagrelor intolerance.
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: After half-dose ticagrelor (loading dose 90mg, and then 45mg bidpo.) treatment for 3 days, the platelet aggregation is effectively inhibited by light transmission aggregometry method and thromboela-stogram. planned to undergo PCI recently planned to DAPT for 1 year after PCI Exclusion Criteria: taken adenosine diphosphate (ADP) receptor antagonists within 2 weeks Platelet count <100g/L; A history of bleeding tendency; Aspirin, ticagrelor or clopidogrel allergies; Severe liver injury.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guangzhong Liu, PhD
Phone
86-451-85555673
Email
lgz2700@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yue Li, PhD
Organizational Affiliation
Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thromboela-Stogram
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Yang, MM
Phone
86-010-801231171

12. IPD Sharing Statement

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Low-dose Ticagrelor in Chinese ACS Patients Undergoing PCI

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