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Point-of-Care Measurements of Platelet Inhibition After Clopidogrel Loading in Patients With Acute Coronary Syndrome: Comparison of Generic Clopidogrel Bisulfate (Plavitor®) With Original Clopidogrel Bisulfate (Plavix®)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
generic clopidogrel (Plavitor® )
original clopidogrel (Plavix® )
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Antiplatelet; clopidogrel; acute coronary syndrome

Eligibility Criteria

19 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with unstable angina or non-ST elevation myocardial infarction
  2. Patients who are planned coronary angiography
  3. Age >18 years, <75 years
  4. Patients who agree to the study protocol

Exclusion Criteria:

  1. Recent treatment with clopidogrel or pletaal or glycoprotein IIb/IIIa Rc antagonist
  2. Active bleeding (peptic ulcer, trauma or intra-cranial hemorrhage)
  3. Allergy to antiplatelet agent
  4. Bleeding diasthesis (blood coagulation disorders, uncontrolled severe hypertension, history of severe bleeding)
  5. History of drug abuse or alcohol abuse
  6. ST elevation myocardial infarction
  7. Pregnancy
  8. Low platelet count (< 100,000 /L) or abnormal results of PT or PTT
  9. Liver disease ( bilirubin > 2 mg/dL, AST or ALT > 100 IU)
  10. Renal failure ( Cr > 2.0 mg/dL)
  11. Malignancy
  12. Proton pump inhibitor, NSAIDs statin (except atorvastatin)

Sites / Locations

  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

original Clopidogrel Bisulfate (Plavix®)

generic Clopidogrel Bisulfate (Plavitor®)

Arm Description

original Clopidogrel Bisulfate (Plavix®) 600mg loading

generic Clopidogrel Bisulfate (Plavitor®) 600mg loading

Outcomes

Primary Outcome Measures

PRU level at 2 hours after clopidogrel loading

Secondary Outcome Measures

PRU level by VerifyNow P2Y12 at 4 -, 8- and 24 hours after clopidogrel loading
ARU level by VerifyNow before and 2 hours after loading
Composite of death, myocardial infarction, target vessel revascularization
Stent thrombosis by Academic Research Consortium definition
Incidence of TIMI major bleedings

Full Information

First Posted
February 11, 2014
Last Updated
February 11, 2014
Sponsor
Ajou University School of Medicine
Collaborators
Dong-A Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT02060786
Brief Title
Point-of-Care Measurements of Platelet Inhibition After Clopidogrel Loading in Patients With Acute Coronary Syndrome: Comparison of Generic Clopidogrel Bisulfate (Plavitor®) With Original Clopidogrel Bisulfate (Plavix®)
Official Title
Point-of-Care Measurements of Platelet Inhibition After Clopidogrel Loading in Patients With Acute Coronary Syndrome: Comparison of Generic Clopidogrel Bisulfate (Plavitor®) With Original Clopidogrel Bisulfate (Plavix®)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
Collaborators
Dong-A Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study demonstrates the effect of generic clopidogrel bisulfate (Plavitor®) in comparison with the original clopidogrel bisulfate (Plavix®) in patients with acute coronary syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Antiplatelet; clopidogrel; acute coronary syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
original Clopidogrel Bisulfate (Plavix®)
Arm Type
Active Comparator
Arm Description
original Clopidogrel Bisulfate (Plavix®) 600mg loading
Arm Title
generic Clopidogrel Bisulfate (Plavitor®)
Arm Type
Experimental
Arm Description
generic Clopidogrel Bisulfate (Plavitor®) 600mg loading
Intervention Type
Drug
Intervention Name(s)
generic clopidogrel (Plavitor® )
Intervention Type
Drug
Intervention Name(s)
original clopidogrel (Plavix® )
Primary Outcome Measure Information:
Title
PRU level at 2 hours after clopidogrel loading
Time Frame
2 hours after clopidogrel loading
Secondary Outcome Measure Information:
Title
PRU level by VerifyNow P2Y12 at 4 -, 8- and 24 hours after clopidogrel loading
Time Frame
4 -, 8- and 24 hours after clopidogrel loading
Title
ARU level by VerifyNow before and 2 hours after loading
Time Frame
2 hours after loading
Title
Composite of death, myocardial infarction, target vessel revascularization
Time Frame
at 30 days
Title
Stent thrombosis by Academic Research Consortium definition
Time Frame
at 30 days
Title
Incidence of TIMI major bleedings
Time Frame
at 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with unstable angina or non-ST elevation myocardial infarction Patients who are planned coronary angiography Age >18 years, <75 years Patients who agree to the study protocol Exclusion Criteria: Recent treatment with clopidogrel or pletaal or glycoprotein IIb/IIIa Rc antagonist Active bleeding (peptic ulcer, trauma or intra-cranial hemorrhage) Allergy to antiplatelet agent Bleeding diasthesis (blood coagulation disorders, uncontrolled severe hypertension, history of severe bleeding) History of drug abuse or alcohol abuse ST elevation myocardial infarction Pregnancy Low platelet count (< 100,000 /L) or abnormal results of PT or PTT Liver disease ( bilirubin > 2 mg/dL, AST or ALT > 100 IU) Renal failure ( Cr > 2.0 mg/dL) Malignancy Proton pump inhibitor, NSAIDs statin (except atorvastatin)
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
ZIP/Postal Code
443-720
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25218311
Citation
Seo KW, Tahk SJ, Yang HM, Yoon MH, Shin JH, Choi SY, Lim HS, Hwang GS, Choi BJ, Park JS, Shin JS, Lee YH, Choi YW, Park SJ, Jin XJ. Point-of-care measurements of platelet inhibition after clopidogrel loading in patients with acute coronary syndrome: comparison of generic and branded clopidogrel bisulfate. Clin Ther. 2014 Nov 1;36(11):1588-94. doi: 10.1016/j.clinthera.2014.07.018. Epub 2014 Sep 15.
Results Reference
derived

Learn more about this trial

Point-of-Care Measurements of Platelet Inhibition After Clopidogrel Loading in Patients With Acute Coronary Syndrome: Comparison of Generic Clopidogrel Bisulfate (Plavitor®) With Original Clopidogrel Bisulfate (Plavix®)

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