Different Dosage of Domestic and Imported Clopidogrel on the Platelet Inhibition Ratio in Patients Undergoing PCI
Primary Purpose
Coronary Heart Disease
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring Clopidogrel; Platelet Inhibition Ratio
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Domestic Clopidogrel 300mg
Domestic Clopidogrel 600mg
Imported Clopidogrel 300mg
Imported Clopidogrel 600mg
Arm Description
Domestic Clopidogrel 300mg
Domestic Clopidogrel 600mg
Imported Clopidogrel 300mg
Imported Clopidogrel 600mg
Outcomes
Primary Outcome Measures
ADP- induced platelet inhibition rate
ADP- induced platelet inhibition rate
ADP- induced platelet inhibition rate
Secondary Outcome Measures
R value (min)
Full Information
NCT ID
NCT03006835
First Posted
December 27, 2016
Last Updated
December 27, 2016
Sponsor
Xijing Hospital
Collaborators
Shenzhen Salubris Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03006835
Brief Title
Different Dosage of Domestic and Imported Clopidogrel on the Platelet Inhibition Ratio in Patients Undergoing PCI
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
Collaborators
Shenzhen Salubris Pharmaceuticals Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Clopidogrel; Platelet Inhibition Ratio
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Domestic Clopidogrel 300mg
Arm Type
Experimental
Arm Description
Domestic Clopidogrel 300mg
Arm Title
Domestic Clopidogrel 600mg
Arm Type
Experimental
Arm Description
Domestic Clopidogrel 600mg
Arm Title
Imported Clopidogrel 300mg
Arm Type
Experimental
Arm Description
Imported Clopidogrel 300mg
Arm Title
Imported Clopidogrel 600mg
Arm Type
Active Comparator
Arm Description
Imported Clopidogrel 600mg
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Primary Outcome Measure Information:
Title
ADP- induced platelet inhibition rate
Time Frame
2 hours after the loading dose
Title
ADP- induced platelet inhibition rate
Time Frame
6 hours after the loading dose
Title
ADP- induced platelet inhibition rate
Time Frame
30 days after the loading dose
Secondary Outcome Measure Information:
Title
R value (min)
Time Frame
2 hours after the loading dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yi liu, doctor
Phone
86-029-84775183
Email
1391643423@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ruining zhang, doctor
Organizational Affiliation
Xijing Hospital, The Fourth Military Medical University, 15 Changle West Road, Xi'an, 710032, China
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Different Dosage of Domestic and Imported Clopidogrel on the Platelet Inhibition Ratio in Patients Undergoing PCI
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