Different Dosage of Domestic and Imported Clopidogrel on the Platelet Inhibition Ratio in Patients Undergoing PCI

Study Overview
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Brief Summary
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This is a single-center, randomized, single-blind, investigator-initiated, pharmacological study with a parallel design. Patients with non-ACS undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1:1:1 ratio to the following treatment groups: Group Α: Domestic Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day. Group B: Domestic Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day. Group B: Imported Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day. Group D: Imported Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day. Platelet inhibition ratio assessment by thrombelastogram will be performed，2 hours after the loading dose(Day 0)， 6 hours after thrombelastogram (Day 0), 30 day after thrombelastogram. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other adverse events)will be performed until Day 30.

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is scheduled to undergo non-urgent PCI The patient is between 18 and 75 years of age (inclusive) and willing to comply with the protocol The patient or legally acceptable representative is able to read and give written informed consent and has signed an informed consent form approved by the Investigator's IRB/IEC Exclusion Criteria: Estimated or measured weight < 55 kg Acute non-ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI) within 7 days prior to PCI Uncontrolled hypertension at the time of initial study drug administration defined as measured systolic blood pressure > 190 mm Hg or diastolic blood pressure > 108 mm Hg Patient has received a clopidogrel loading dose (≥300 mg) within 30 days prior to randomization; patients on maintenance clopidogrel may be enrolled Administration of thrombolytic agents, fondaparinux, or oral anticoagulants (e.g., warfarin) within the 7 days prior to PCI Estimated creatinine clearance (e.g. Cockcroft-Gault) < 45 mL/min Anemia with hemoglobin level < 10 g/dL Thrombocytopenia (platelet count < 100,000/mm3) ALT and/or AST > 2.5 x the ULN or other indication of clinically significant hepatic dysfunction Facial or head trauma within the last 30 days Intraocular hemorrhage within the last 30 days Gastrointestinal bleeding within the last 30 days Active bleeding, or history of a bleeding disorder or known intracranial vascular malformation Known allergy or contraindication to aspirin, heparin, clopidogrel, or to any contrast media Participation in any investigational drug study within 30 days prior to enrollment.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Domestic Clopidogrel 300mg<br>Domestic Clopidogrel 300mg | Drug: Clopidogrel<br> <br> |
| Experimental: Domestic Clopidogrel 600mg<br>Domestic Clopidogrel 600mg | Drug: Clopidogrel<br> <br> |
| Experimental: Imported Clopidogrel 300mg<br>Imported Clopidogrel 300mg | Drug: Clopidogrel<br> <br> |
| Active Comparator: Imported Clopidogrel 600mg<br>Imported Clopidogrel 600mg | Drug: Clopidogrel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADP- induced platelet inhibition rate |  | 2 hours after the loading dose | 
| ADP- induced platelet inhibition rate |  | 6 hours after the loading dose | 
| ADP- induced platelet inhibition rate |  | 30 days after the loading dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R value (min) |  | 2 hours after the loading dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clopidogrel; Platelet Inhibition Ratio