NCT00644657

Brief Summary

This study will explore the effect of clopidogrel on coated-platelets in patients who are given a loading dose before diagnostic catheterization or percutaneous coronary intervention. We hypothesis that clopidogrel will reduce the percentage of platelets that are coated and therefore more hypercoagulable.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2007

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

March 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

October 7, 2011

Completed
Last Updated

October 7, 2011

Status Verified

September 1, 2011

Enrollment Period

1.5 years

First QC Date

March 24, 2008

Results QC Date

January 6, 2011

Last Update Submit

September 7, 2011

Conditions

Keywords

Platelets, platelet aggregation inhibitors

Outcome Measures

Primary Outcomes (1)

  • The Percentage of Coated Platelets After the Administration of Clopidogrel in Patients Undergoing Cardiac Catheterization and/or Angioplasty

    The percentage of platelets that are collagen coated after the administration of clopidogrel.

    24 hours after the administration of clopidotrel

Secondary Outcomes (1)

  • The Percentage of Coated Platelets After Coronary Angiography and/or PCI

    6 hrs after procedure

Interventions

All subjects will receive a 300 mg loading dose

Also known as: Plavix

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients given clopidogrel loading dose before scheduled catheterization or percutaneous intervention

You may not qualify if:

  • Acute coronary syndrome
  • Unable to tolerate clopidogrel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, 1F187

Oklahoma City, Oklahoma, 73104-5076, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseaseChest Pain

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Limited to primarily Male VA population.

Results Point of Contact

Title
Eliot Schechter, MD
Organization
University of Oklahoma Health Sciences Center

Study Officials

  • Eliot Schechter, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2008

First Posted

March 27, 2008

Study Start

March 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

October 7, 2011

Results First Posted

October 7, 2011

Record last verified: 2011-09

Locations