NCT01865890

Brief Summary

The investigators are trying to find out if Clopidogrel (Plavix) is as effective in hemodialysis patients as in patients not hemodialysed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

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

June 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

10 months

First QC Date

June 9, 2010

Last Update Submit

May 30, 2013

Conditions

Cardiovascular Disease

Keywords

Plavix or clopidogrel resistance

Outcome Measures

Primary Outcomes (1)

  • Prevalence Of Plavix resistance

    Plavix resistance is reported using the PRU values given by the VerifyNow machine. PRU is P2Y12 Reaction Units which is correlated with platelet aggregation.

    1 day ( one study visit)

Secondary Outcomes (1)

  • assess the risk factors for plavix resistance in the hemodialysis population

    1 day (one study visit)

Study Arms (1)

patient on hemodialysis taking plavix

patient on hemodialysis taking plavix

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hemodialysis patients who are taking plavix daily

You may qualify if:

  • All patients on hemodialysis taking Plavix

You may not qualify if:

  • known to have bleeding disorder
  • Severely anemic with hemoglobin level (Hb) \< 10g/dl
  • Low Platelets \< 10000

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Suzanne El-Sayegh, MD

    Staten Island University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nephrology Attending, Assoc. Chair of Medicine

Study Record Dates

First Submitted

June 9, 2010

First Posted

May 31, 2013

Study Start

June 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations

US(1)