Efficacy and Safety Study of Ticagrelor

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and safety of ticagrelor with clopidogrel

Detailed Description
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180 elective percutaneous coronary intervention patients with clopidogrel resistance were randomized to three groups, Group 1:received clopidogrel 75mg qd ;Group 2:received clopidogrel 150mg qd ; Group 3:received ticagrelor 90mg bid after PCI.Platelet funtion were tested by flowcytometric vasodilator-stimulated phosphoprotein(VASP) analysis before PCI,and 3days,7days and 1 month after PCI,respectively.The aim of our study is to compare the efficacy and safety of ticagrelor with clopidogrel

Official Title
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The Effect of Ticagrelor on Acute Coronary Syndrome Patients With Clopidogrel Resistance Undergoing Percutaneous Coronary Intervention

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Clopidogrel
* Drug: Ticagrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Clinical diagnosis of ACS 2.undergoing PCI 3.with clopidogrel resistance Exclusion Criteria: 1.any contraindication against the use of clopidogrel and ticagrel 2.Contradiction to aspirin and contrast medium 3.Life expectancy less than 1 year 4.Tumor or inflammatory diseases5. fibrinolytic therapy within 24 hours before randomization 6.a need for oral anticoagulation therapy 7. an increased risk of bradycardia 8.concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer 9.a history of asthma.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>Group 1 will be administered with Clopidogrel 75mg daily until the end of the trial | Drug: Clopidogrel<br>* After 600mg loading dose, 75mg or 150mg Qd<br>* Other names: Plavix;|
| Experimental: group 2<br>Group 2 will be administered with Clopidogrel 150mg daily until the end of trial | Drug: Clopidogrel<br>* After 600mg loading dose, 75mg or 150mg Qd<br>* Other names: Plavix;|
| Experimental: group 3<br>Group 3 will be administered with Ticagrelor 90mg twice daily until the end of the trial | Drug: Ticagrelor<br>* 90mg Bid<br>* Other names: Brilique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRI | Platelet funtion were tested by flowcytometric vasodilator-stimulated phosphoprotein(VASP) analysis.And a platelet reactivity index (PRI) was calculated. | post operative 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events(MACEs) | cardiovascular death,angiographically conﬁrmed stent thrombosis, recurrent acute coronary syndrome deﬁned by the American College of Cardiology/American Heart Association guidelines,and recurrent revascularization by either coronary angioplasty or bypass surgery | follow-up for 1 month | 
| major and minor bleeding | Major bleeding was deﬁned as intracranial bleeding or clinically-overt bleeding associated with a decrease in hemoglobin of 50 g/L, according to the Thrombolysis inMyocardial Infarction (TIMI) criteria .Minor bleeding was also deﬁned according to TIMI criteria . | follow-up for 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACS, CR, PCI, Platelet funtion, Ticagrelor