Status:
UNKNOWN
Prevalence and Level of Thienopyridine Resistance Seen in a Contemporary Percutaneous Coronary Intervention or Coronary Artery Bypass Graft Population
Lead Sponsor:
Medstar Health Research Institute
Conditions:
Increased Drug Resistance
Eligibility:
All Genders
18+ years
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 int...
Detailed Description
This is a prospective cohort study of 1000 patients presenting to the Washington Hospital Center for percutaneous coronary intervention or coronary artery bypass surgery. The aim of this prospective ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2016
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT01408927
Start Date
October 1 2008
End Date
January 1 2016
Last Update
August 11 2014
Active Locations (1)
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1
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010