NCT00606151

Brief Summary

The purpose of this study is to determine if an intravenous (IV) antiplatelet medication is as safe and effective at preventing clot formation in your stented artery as compared in people who have stopped clopidogrel prior to surgery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

March 26, 2009

Status Verified

March 1, 2009

Enrollment Period

1 year

First QC Date

January 22, 2008

Last Update Submit

March 25, 2009

Conditions

Stent Thrombosis

Keywords

drug eluding stentsperioperative bridgingStents

Outcome Measures

Primary Outcomes (1)

  • stent thrombosis

    hospitalization

Eligibility Criteria

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

We intend to assess, in a prospective observational manner, the clinical course of patients who have undergone stent implantation less than 6 months prior to a surgical procedure requiring discontinuation of clopidogrel therapy and the efficacy of intravenous antiplatelet therapy to prevent morbidity related to stent thrombosis.

You may qualify if:

  • Aged 18 years or greater, able to give consent
  • DES implantation \< or = 6 months prior to admission
  • Undergoing an invasive surgical procedure that will require cessation of clopidogrel therapy for \>48 hours

You may not qualify if:

  • Age \< 18 years
  • Refusal to give consent
  • Surgical procedure performed without discontinuation of clopidogrel therapy (or \< 48h of clopidogrel cessation)
  • Ongoing anticoagulant therapy other than aspirin (i.e. warfarin, ticlopidine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

  • Matthew (Casey) Becker, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 1, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

March 26, 2009

Record last verified: 2009-03

Locations

US(1)