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

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 4

Conditions: Coronary Heart Disease

Treatments: Drug: Clopidogrel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03006835

ky20162060-2

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient is scheduled to undergo non-urgent PCI
2. The patient is between 18 and 75 years of age (inclusive) and willing to comply with the protocol
3. 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

1. Estimated or measured weight < 55 kg
2. Acute non-ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI) within 7 days prior to PCI
3. 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
4. Patient has received a clopidogrel loading dose (≥300 mg) within 30 days prior to randomization; patients on maintenance clopidogrel may be enrolled
5. Administration of thrombolytic agents, fondaparinux, or oral anticoagulants (e.g., warfarin) within the 7 days prior to PCI
6. Estimated creatinine clearance (e.g. Cockcroft-Gault) < 45 mL/min
7. Anemia with hemoglobin level < 10 g/dL
8. Thrombocytopenia (platelet count < 100,000/mm3)
9. ALT and/or AST > 2.5 x the ULN or other indication of clinically significant hepatic dysfunction
10. Facial or head trauma within the last 30 days
11. Intraocular hemorrhage within the last 30 days
12. Gastrointestinal bleeding within the last 30 days
13. Active bleeding, or history of a bleeding disorder or known intracranial vascular malformation
14. Known allergy or contraindication to aspirin, heparin, clopidogrel, or to any contrast media
15. Participation in any investigational drug study within 30 days prior to enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Domestic Clopidogrel 300mg

Experimental group

Description:

Domestic Clopidogrel 300mg

Treatment:

Drug: Clopidogrel

Domestic Clopidogrel 600mg

Experimental group

Description:

Domestic Clopidogrel 600mg

Treatment:

Drug: Clopidogrel

Imported Clopidogrel 300mg

Experimental group

Description:

Imported Clopidogrel 300mg

Treatment:

Drug: Clopidogrel

Imported Clopidogrel 600mg

Active Comparator group

Description:

Imported Clopidogrel 600mg

Treatment:

Drug: Clopidogrel