NCT01408927

Brief Summary

The primary objective of this prospective clinical registry is to determine the prevalence and level of thienopyridine resistance seen in a population undergoing contemporary percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2008

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

August 11, 2014

Status Verified

August 1, 2014

Enrollment Period

7.3 years

First QC Date

July 28, 2011

Last Update Submit

August 8, 2014

Conditions

Increased Drug Resistance

Keywords

Thienopyridine resistanceAspirin resistancePlatelet reactivity

Outcome Measures

Primary Outcomes (1)

  • The prevalence and degree of thienopyridine resistance

    Thienopyridine resistance will be assessed by: oThe VASP assay, which measures the platelet reactivity index; and/or oThe VerifyNow P2Y12 receptor inhibition assay, which measures P2Y12 reaction units (PRU); and/or oThe Chrono-Log Lumi-Aggregometer, which measures platelet aggregation (via optical density or electrical impedance) in response to ADP stimulation; and/or oThe PlaCor PRT 7000 platelet reactivity assay

    Duration of hospital stay; average hospital stay of less than 48 hours

Secondary Outcomes (2)

  • The prevalence of aspirin resistance

    Duration of hospital stay; average hospital stay of less than 48 hours

  • Correlate levels of platelet reactivity with the presence of selected genetic polymorphisms

    Duration of hospital stay; average hospital stay of less than 48 hours

Interventions

Thienopyridine resistance testingOTHER

Thienopyridine resistance will be measured by flow cytometry of vasodilator-stimulated phosphoprotein (VASP) phosphorylation, and/or VerifyNow P2Y12 assay, and/or the Chrono-Log Lumi-Aggregometer, and/or the PlaCor PRT 7000 platelet reactivity assay.

Aspirin resistance testingOTHER

Aspirin resistance will be measured by the VerifyNow aspirin resistance assay.

Genetic polymorphism assessmentOTHER

The presence of minor alleles in selected single nucleotide polymorphisms (SNPs) as measured by the Applied Biosystems Open Array system.

Eligibility Criteria

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

1000 patients, male or female, older than 18 years of age, who are scheduled for or underwent percutaneous coronary intervention (PCI) or CABG and have been treated with a loading dose of a thienopyridine or on a maintenance dose of a thienopyridine.

You may qualify if:

  • Patient \>18 years old.
  • PCI group only: Patient scheduled to undergo cardiac catheterization or underwent percutaneous coronary intervention (PCI), during hospital stay.
  • CABG group only: Patient is scheduled to undergo, or has underwent, coronary artery bypass surgery with at least one saphenous vein graft.
  • Treated with a loading dose of clopidogrel or prasugrel at least 6 hours prior to the blood draw, or on a maintenance dose of clopidogrel or prasugrel for a minimum of 5 days.
  • Genetic testing subgroup only: Patient has undergone PCI (only), and has been treated with a thienopyridine as in 4.

You may not qualify if:

  • Known allergies to aspirin, clopidogrel, or prasugrel;
  • Use of a glycoprotein (GP) IIb/IIIa within 8 hours of the blood draw;
  • Patient known to be pregnant or lactating;
  • Patient with known history of bleeding diathesis or currently active bleeding;
  • Platelet count \<100,000/mm the day of the blood draw;
  • Hematocrit \<25% the day of the blood draw;
  • On warfarin therapy at the time of the blood draw;
  • Known blood transfusion within the preceding 10 days of the blood draw;
  • Patient who has received NSAID (not including ASA) within preceding 24 hours of the blood draw;
  • Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Central Study Contacts

Ron Waksman, MD

CONTACT

202-877-5975ron.waksman@medstar.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2011

First Posted

August 3, 2011

Study Start

October 1, 2008

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

August 11, 2014

Record last verified: 2014-08

Locations

US(1)