The Optimal Strategy of Switching From Clopidogrel to Ticagrelor in Patients With Complexity of Coronary Artery Disease

Study Overview
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Brief Summary
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The study is to further exploring the optimal switching strategy by evaluating the pharmacodynamic responses as well as adverse events in patients with complexity of coronary artery disease managed by percutaneous coronary intervention (PCI). All participants will be divided into three groups and recieving ticagrelor 90mg plus aspirin 100mg at 12 hours after the last dose of clopidogrel; recieving ticagrelor 90mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel; recieving ticagrelor 180mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel.

Official Title
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The Optimal Strategy of Switching From Clopidogrel to Ticagrelor in Patients With Complexity of Coronary Artery Disease

Conditions
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Coronary Artery Disease, Ticagrelor

Intervention / Treatment
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* Drug: Ticagrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-75 Patients with complexity of CAD determined by coronary angiography and implanted stent successfully Taking clopidogrel 75mg daily over 5 days or paients never took clopidogrel previously should receive 300-600mg drugs at least 12 hours before coronary angiography Agreeing to participate in this trial and signed the written informed consent. Exclusion Criteria: They contraindicated with ticagrelor (including: allergying to ticagrelor or its active metabolite Concomitanting therapy with a strong cytochrome P-450 3A inhibitor or inducer Previous intracranial haemorrhage or ongoing bleeds Moderate or severe hepatic impairment) Having a previous medication with ticagrelor or long term anticoagulation Having a history of asthma or chronic obstructive pulmonary disease (COPD) and recurrent attacked Having an uncontrolled hypertension>180/110mmHg Having a hemoglobin<100g/L 9.Having a platelet counts<100×10^9/L Having severe renal impairment (clearance<30mL/min) Having a history of hepaein-induced thrombocytopenia (HIT) Having a pregnancy or were during lactation.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor, 90mg, 12h<br> | Drug: Ticagrelor<br>* Ticagrelor, 90mg, 90mg twice daily<br>|
| Experimental: Ticagrelor, 90mg, 24h<br> | Drug: Ticagrelor<br>* Ticagrelor, 90mg, 90mg twice daily<br>|
| Experimental: Ticagrelor, 180mg, 24h<br> | Drug: Ticagrelor<br>* Ticagrelor, 90mg, 90mg twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet function assessments | The primary endpoint was the comparations between the three projects for the value changes of maximal platelet aggregation (MPA) measured by Light Transmittance Aggregometry (LTA) at 2 hours after switching strategies. | 7 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ticagrelor, Clopidogrel, Switching strategy