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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Drug: Clopidogrel

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Domestic Clopidogrel 300mg	Drug: Clopidogrel
Experimental: Domestic Clopidogrel 600mg	Drug: Clopidogrel
Experimental: Imported Clopidogrel 300mg	Drug: Clopidogrel
Active Comparator: Imported Clopidogrel 600mg	Drug: Clopidogrel

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Shenzhen Salubris Pharmaceuticals Co., Ltd.
• Investigators: Study Director: ruining zhang, doctor, Xijing Hospital, The Fourth Military Medical University, 15 Changle West Road, Xi'an, 710032, China

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 27, 2016
• First Submitted That Met QC Criteria: December 27, 2016
• First Posted (Estimate): December 30, 2016

Study Record Updates

• Last Update Posted (Estimate): December 30, 2016
• Last Update Submitted That Met QC Criteria: December 27, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Clopidogrel; Platelet Inhibition Ratio
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: ky20162060-2