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

NCT03006835 | Unknown Phase 4

• 1 other identifier: ky20162060-2
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• R value (min)

  2 hours after the loading dose

Study Arms (4)

Domestic Clopidogrel 300mg

EXPERIMENTAL

Domestic Clopidogrel 300mg

Drug: Clopidogrel

Domestic Clopidogrel 600mg

EXPERIMENTAL

Domestic Clopidogrel 600mg

Drug: Clopidogrel

Imported Clopidogrel 300mg

EXPERIMENTAL

Imported Clopidogrel 300mg

Drug: Clopidogrel

Imported Clopidogrel 600mg

ACTIVE COMPARATOR

Imported Clopidogrel 600mg

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

Domestic Clopidogrel 300mg; Domestic Clopidogrel 600mg; Imported Clopidogrel 300mg; Imported Clopidogrel 600mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead
• Shenzhen Salubris Pharmaceuticals Co., Ltd.: collaborator

MeSH Terms

Conditions

Coronary Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• ruining zhang, doctor

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

  STUDY DIRECTOR

Central Study Contacts

yi liu, doctor

CONTACT

86-029-84775183; 1391643423@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: December 30, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 30, 2016

Record last verified: 2016-12