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出境医 / 临床实验 / Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease

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

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.

Condition or disease Intervention/treatment Phase
Platelet Reactivity Drug: Ticagrelor 90mg Drug: Clopidogrel 75mg Phase 4

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Study
Actual Study Start Date : June 24, 2019
Actual Primary Completion Date : December 9, 2020
Actual Study Completion Date : December 9, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Ticagrelor
To observe the safety and efficacy of standard-dose ticagrelor in Chinese patients with Stable Coronary Artery Disease
 Drug: Ticagrelor 90mg
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).
Other Name: Ticagrelor

Drug: Clopidogrel 75mg
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).
Other Name: Clopidogrel
Active Comparator: Clopidogrel
To observe the safety and efficacy of standard-dose clopidogrel in Chinese patients with Stable Coronary Artery Disease
 Drug: Ticagrelor 90mg
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).
Other Name: Ticagrelor

Drug: Clopidogrel 75mg
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).
Other Name: Clopidogrel
Outcome Measures
Primary Outcome Measures :
  1. The platelet inhibition ratio [ Time Frame: up to 3 months ]
    Thromboelastogram was used to measure platelet inhibition ratio.


Secondary Outcome Measures :
  1. The platelet aggregation ratio. [ Time Frame: up to 3 months ]
    Light transmittance aggregometry method was used to measure platelet aggregation ratio.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
China, Heilongjiang
Thrombelastogram
Harbin, Heilongjiang, China, 150001
Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University
Investigators
Layout table for investigator information
Principal Investigator: Yue Li, Doctor First Affiliated Hospital of Harbin Medical University
Tracking Information
First Submitted Date  ICMJE June 26, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date January 12, 2021
Actual Study Start Date  ICMJE June 24, 2019
Actual Primary Completion Date December 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2019) 		The platelet inhibition ratio [ Time Frame: up to 3 months ]
Thromboelastogram was used to measure platelet inhibition ratio.
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019) 		The platelet inhibition ratio [ Time Frame: up to 3 months ]
Thrombelastography was used to measure platelet inhibition ratio.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2019) 		The platelet aggregation ratio. [ Time Frame: up to 3 months ]
Light transmittance aggregometry method was used to measure platelet aggregation ratio.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2019) 		The platelet aggregation ratio. [ Time Frame: up to 3 months ]
Light transmission aggregometry method was used to measure platelet aggregation ratio.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease
Official Title  ICMJE Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Platelet Reactivity
Intervention  ICMJE
  • Drug: Ticagrelor 90mg
    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).
    Other Name: Ticagrelor
  • Drug: Clopidogrel 75mg
    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).
    Other Name: Clopidogrel
Study Arms  ICMJE
  • Experimental: Ticagrelor
    To observe the safety and efficacy of standard-dose ticagrelor in Chinese patients with Stable Coronary Artery Disease
    Interventions:
    • Drug: Ticagrelor 90mg
    • Drug: Clopidogrel 75mg
  • Active Comparator: Clopidogrel
    To observe the safety and efficacy of standard-dose clopidogrel in Chinese patients with Stable Coronary Artery Disease
    Interventions:
    • Drug: Ticagrelor 90mg
    • Drug: Clopidogrel 75mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2021) 		50
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2019) 		30
Actual Study Completion Date  ICMJE December 9, 2020
Actual Primary Completion Date December 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04001894
Other Study ID Numbers  ICMJE 20190515
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party First Affiliated Hospital of Harbin Medical University
Study Sponsor  ICMJE First Affiliated Hospital of Harbin Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yue Li, Doctor First Affiliated Hospital of Harbin Medical University
PRS Account First Affiliated Hospital of Harbin Medical University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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