- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04001894
Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease
December 20, 2021 updated by: Yue LI, First Affiliated Hospital of Harbin Medical University
Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Heilongjiang
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Harbin, Heilongjiang, China, 150001
- Thrombelastogram
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ticagrelor
To observe the safety and efficacy of standard-dose ticagrelor in Chinese patients with Stable Coronary Artery Disease
|
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 Names:
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 Names:
|
ACTIVE_COMPARATOR: Clopidogrel
To observe the safety and efficacy of standard-dose clopidogrel in Chinese patients with Stable Coronary Artery Disease
|
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 Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The platelet inhibition ratio
Time Frame: up to 3 months
|
Thromboelastogram was used to measure platelet inhibition ratio.
|
up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The platelet aggregation ratio.
Time Frame: up to 3 months
|
Light transmittance aggregometry method was used to measure platelet aggregation ratio.
|
up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 2, 2019
Primary Completion (ACTUAL)
December 9, 2020
Study Completion (ACTUAL)
December 9, 2020
Study Registration Dates
First Submitted
June 26, 2019
First Submitted That Met QC Criteria
June 26, 2019
First Posted (ACTUAL)
June 28, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 11, 2022
Last Update Submitted That Met QC Criteria
December 20, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Ticagrelor
- Clopidogrel
Other Study ID Numbers
- 20190515
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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