NCT02060786

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
Last Updated

February 12, 2014

Status Verified

February 1, 2014

Enrollment Period

2.7 years

First QC Date

February 11, 2014

Last Update Submit

February 11, 2014

Conditions

Acute Coronary Syndrome

Keywords

Antiplatelet; clopidogrel; acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

  • PRU level at 2 hours after clopidogrel loading

    2 hours after clopidogrel loading

Secondary Outcomes (5)

  • PRU level by VerifyNow P2Y12 at 4 -, 8- and 24 hours after clopidogrel loading

    4 -, 8- and 24 hours after clopidogrel loading

  • ARU level by VerifyNow before and 2 hours after loading

    2 hours after loading

  • Composite of death, myocardial infarction, target vessel revascularization

    at 30 days

  • Stent thrombosis by Academic Research Consortium definition

    at 30 days

  • Incidence of TIMI major bleedings

    at 30 days

Study Arms (2)

original Clopidogrel Bisulfate (Plavix®)

ACTIVE COMPARATOR

original Clopidogrel Bisulfate (Plavix®) 600mg loading

Drug: original clopidogrel (Plavix® )

generic Clopidogrel Bisulfate (Plavitor®)

EXPERIMENTAL

generic Clopidogrel Bisulfate (Plavitor®) 600mg loading

Drug: generic clopidogrel (Plavitor® )

Interventions

generic clopidogrel (Plavitor® )DRUG
generic Clopidogrel Bisulfate (Plavitor®)
original clopidogrel (Plavix® )DRUG
original Clopidogrel Bisulfate (Plavix®)

Eligibility Criteria

Age19 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Hospital

Suwon, 443-720, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 25218311DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 12, 2014

Study Start

October 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 12, 2014

Record last verified: 2014-02

Locations

KR(1)