Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI

Study Overview
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Brief Summary
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It is designed to test the hypothesis that high loading dose(360mg) ticagrelor versus conventional loading dose(180mg) will result in a higher inhibition of platelet aggregation(IPA) without increasing the bleeding events.

Detailed Description
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After providing written informed consent, all patients will be randomized to receive ticagrelor 360mg or 180mg loading dose(LD),then 90mg bid maintenance dose starting 12 hours after LD.PCI will performed in 2h-72h after they are given the loading dose.All patients should receive acetylsalicylic acid (ASA) 75 to 100 mg daily unless intolerant.IPA at 0, 0.5, 1, 2, 8, 24h after the loading dose of ticagrelor will be measured. CK-MB, troponin I, myoglobin, CRP will be detected at 0h, before PCI, 8h after PCI, 24h after PCI. ECG will be conducted at 0h and within 24h after PCI. Patients returned 28 days for follow-up visits after the loading dose of ticagrelor, documented any adverse events.

Official Title
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Randomized Trial of Different Loading Dose of Ticagrelor for Antiplatelet Effect in Patients With Non -ST-segment Elevation ACS Undergoing Percutaneous Coronary Intervention

Conditions
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Non ST Segment Elevation Acute Coronary Syndrome

Intervention / Treatment
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* Drug: ticagrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study specific procedures. Male or non-pregnant female; aged from 18 to 80 years old. Patients with non-ST-segment elevation acute coronary syndromes who were scheduled to undergoing PCI. Exclusion Criteria: Any contraindication against the use of ticagrelor. On treatment with a P2Y12 receptor antagonist in past 30 days. Known allergies to aspirin or ticagrelor. On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban). Known blood dyscrasia or bleeding diathesis. ST-segment elevation acute myocardial infarction. Non-ST segment elevation acute coronary syndrome with high-risk features warranting emergency coronary angiography. Left ventricular ejection fraction ≤30%; renal failure with creatinine 3 mg/dl; history of liver disease; an increased risk of bradycardia, and concomitant therapy with drugs interfering with CYP3A4 metabolism.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high loading dose of ticagrelor<br>Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose. | Drug: ticagrelor<br>* Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.<br>* Other names: Brilinta;|
| Active Comparator: conventional loading dose of ticagrelor<br>Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose. | Drug: ticagrelor<br>* Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.<br>* Other names: Brilinta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet Reactivity Index(PRI) Measured by VASP-P | Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index (PRI). | 2 hours after the loading dose of ticagrelor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet Reactivity Index (PRI) Measured by VASP-P |  | 0.5hour,1hour,8hours,24hours after the loading dose of ticagrelor | 
| Bleeding Events |  | follow-up for 28 days after the loading dose of ticagrelor | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ticagrelor, loading dose, non-ST-segment elevation acute coronary syndromes, percutaneous coronary intervention, the antiplatelet effects, bleeding events, major adverse cardiac events