Recruiting

Thienopyridine Resistance

Sponsor:

Medstar Health Research Institute

Code:

NCT01408927

Conditions

Increased Drug Resistance

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Thienopyridine resistance testing

Aspirin resistance testing

Genetic polymorphism assessment

Study Details

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).

Conditions

Increased Drug Resistance

Study ID

NCT01408927

Start date

Oct, 2008

Status verified date

Aug, 2014

Completion date

Jan, 2016

Anticipated

Primary completion date

Jan, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patient >18 years old.
2. PCI group only: Patient scheduled to undergo cardiac catheterization or underwent percutaneous coronary intervention (PCI), during hospital stay.
3. CABG group only: Patient is scheduled to undergo, or has underwent, coronary artery bypass surgery with at least one saphenous vein graft.
4. 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.
5. Genetic testing subgroup only: Patient has undergone PCI (only), and has been treated with a thienopyridine as in 4.

Exclusion Criteria:

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Thienopyridine resistance testing

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 testing

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

Genetic polymorphism assessment

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

Primary outcome measure

  • The prevalence and degree of thienopyridine resistance [ Time Frame: Duration of hospital stay; average hospital stay of less than 48 hours ]

Central Contacts and Locations

Central contacts

Locations

Washington Hospital Center

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

Principal Investigator:

Ron Waksman, MD

More Information

Sponsor

Medstar Health Research Institute

Last update posted

Aug 11, 2014

Last verified

Aug, 2014

Keywords

  • Thienopyridine resistance
  • Aspirin resistance
  • Platelet reactivity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2014-08-11.