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

NCT ID: NCT03006835

Last Updated: 2016-12-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-12-31

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.

Conditions

Coronary Heart Disease

Keywords

Clopidogrel; Platelet Inhibition Ratio

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Domestic Clopidogrel 300mg

Domestic Clopidogrel 300mg

Group Type: EXPERIMENTAL

Clopidogrel

Intervention Type: DRUG

Domestic Clopidogrel 600mg

Domestic Clopidogrel 600mg

Group Type: EXPERIMENTAL

Clopidogrel

Intervention Type: DRUG

Imported Clopidogrel 300mg

Imported Clopidogrel 300mg

Group Type: EXPERIMENTAL

Clopidogrel

Intervention Type: DRUG

Imported Clopidogrel 600mg

Imported Clopidogrel 600mg

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

Interventions

Clopidogrel

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Salubris Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ruining zhang, doctor

Role: STUDY_DIRECTOR

Xijing Hospital, The Fourth Military Medical University, 15 Changle West Road, Xi'an, 710032, China

Central Contacts

yi liu, doctor

Role: CONTACT

Phone: 86-029-84775183

Email: 1391643423@qq.com

Other Identifiers

ky20162060-2

Identifier Type: -

Identifier Source: org_study_id