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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

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring Clopidogrel; Platelet Inhibition Ratio

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

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

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

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