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Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease

Primary Purpose

Platelet Reactivity

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ticagrelor 90mg
Clopidogrel 75mg
Sponsored by
First Affiliated Hospital of Harbin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Platelet Reactivity focused on measuring Ticagrelor, Clopidogrel, Coronary artery disease, platelet function tests

Eligibility Criteria

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

Inclusion Criteria:•

  • Aged ≥18 years
  • Subjects had documented with stable CAD
  • Women were required to be postmenopausal or surgically sterile
  • Patients were required to discontinue clopidogrel or ticagrelor at least 14 days before randomization
  • Patients were required to discontinue aspirin at least 14 days before randomization.

Exclusion Criteria:

  • Acute coronary syndrome
  • Planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists other than the study medication, or anticoagulant therapy during the study period
  • Platelet count <10×10^4/μL
  • Hstory of bleeding tendency
  • Diagnosed as respiratory or circulatory instability
  • Allergy to ticagrelor or clopidogrel

Sites / Locations

  • Thrombelastogram

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor

Clopidogrel

Arm Description

To observe the safety and efficacy of standard-dose ticagrelor in Chinese patients with Stable Coronary Artery Disease

To observe the safety and efficacy of standard-dose clopidogrel in Chinese patients with Stable Coronary Artery Disease

Outcomes

Primary Outcome Measures

The platelet inhibition ratio
Thromboelastogram was used to measure platelet inhibition ratio.

Secondary Outcome Measures

The platelet aggregation ratio.
Light transmittance aggregometry method was used to measure platelet aggregation ratio.

Full Information

First Posted
June 26, 2019
Last Updated
December 20, 2021
Sponsor
First Affiliated Hospital of Harbin Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04001894
Brief Title
Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease
Official Title
Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 2, 2019 (Actual)
Primary Completion Date
December 9, 2020 (Actual)
Study Completion Date
December 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor reduces thrombotic events in patients with coronary artery disease, but these benefits come at the expense of increased risk of bleeding when compared with aspirin monotherapy. Increased evidence showed that P2Y12 inhibitor monotherapy still maintain antiischemic efficacy while reducing the bleeding risk compared with DAPT. Therefore, the investigators performed this study to observe the efficacy of ticagrelor in comparison to clopidogrel in Chinese patients with stable CAD.
Detailed Description
Ticagrelor is a novel, direct-acting, reversibly binding P2Y12 receptor antagonist. When related with clopidogrel, ticagrelor exhibits a more potent and more predictable antiplatelet effect with a faster onset and offset of action. Current guidelines give a recommendation on the use of dual antiplatelet therapy support ticagrelor 90 mg twice daily over clopidogrel 75 mg daily in addition to aspirin in CAD patients. However, increasing evidence showed ticagrelor increased the risk of bleeding. Recent studies showed that P2Y12 inhibitor monotherapy still maintain antiischemic efficacy while reducing the bleeding risk compared with DAPT. So the investigators performed this randomized, single-blind, crossover clinical trial to observe the effects of standard-dose ticagrelor and standard-dose clopidogrel on platelet reactivity in Chinese patients with stable CAD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platelet Reactivity
Keywords
Ticagrelor, Clopidogrel, Coronary artery disease, platelet function tests

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
To observe the safety and efficacy of standard-dose ticagrelor in Chinese patients with Stable Coronary Artery Disease
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
To observe the safety and efficacy of standard-dose clopidogrel in Chinese patients with Stable Coronary Artery Disease
Intervention Type
Drug
Intervention Name(s)
Ticagrelor 90mg
Other Intervention Name(s)
Ticagrelor
Intervention Description
Ticagrelor (90.0 mg twice daily) for 2 weeks, followed by a 2-week washout period then 2 weeks crossover phase of clopidogrel (75mg once daily).
Intervention Type
Drug
Intervention Name(s)
Clopidogrel 75mg
Other Intervention Name(s)
Clopidogrel
Intervention Description
Clopidogrel (75mg once daily) for 2 weeks, followed by a 2-week washout period then 2 weeks crossover phase of ticagrelor (90.0 mg twice daily).
Primary Outcome Measure Information:
Title
The platelet inhibition ratio
Description
Thromboelastogram was used to measure platelet inhibition ratio.
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
The platelet aggregation ratio.
Description
Light transmittance aggregometry method was used to measure platelet aggregation ratio.
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:• Aged ≥18 years Subjects had documented with stable CAD Women were required to be postmenopausal or surgically sterile Patients were required to discontinue clopidogrel or ticagrelor at least 14 days before randomization Patients were required to discontinue aspirin at least 14 days before randomization. Exclusion Criteria: Acute coronary syndrome Planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists other than the study medication, or anticoagulant therapy during the study period Platelet count <10×10^4/μL Hstory of bleeding tendency Diagnosed as respiratory or circulatory instability Allergy to ticagrelor or clopidogrel
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yue Li, Doctor
Organizational Affiliation
First Affiliated Hospital of Harbin Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thrombelastogram
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease

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