Low-dose Ticagrelor in Chinese ACS Patients Undergoing PCI

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Effectiveness and Safety Analysis of Low-dose and Standard-dose Ticagrelor in Chinese Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: half-dose ticagrelor
* Drug: standard-dose ticagrelor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: half-dose ticagrelor<br> | Drug: half-dose ticagrelor<br>* To observe the effectiveness and safety of ticagrelor 45mg bidpo. in Chinese ACS patients undergoing PCI.<br>|
| Active Comparator: standard-dose ticagrelor<br> | Drug: standard-dose ticagrelor<br>* To observe the effectiveness and safety of ticagrelor 90mg bidpo. in Chinese ACS patients undergoing PCI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thromboela-stogram | inhibition of platelet aggregation (ADP) ; MA (ADP) | up to 6 months | 
| thromboela-stogram | inhibition of platelet aggregation; MA | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | cardiovascular death, non-fatal myocardial infarction and stroke | up to 1 year | 
| Side effects including bleeding and dyspnea |  | up to 1 year | 
| The rate of treatment interruption due to ticagrelor intolerance. |  | up to 1 year |