Trials / Completed
CompletedNCT01406483
Platelet Reactivity in Patients on a Thienopyridine and Awaiting Coronary Artery Bypass Grafting
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Medstar Health Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this exploratory cohort study is to describe levels of platelet reactivity in patients on a thienopyridine awaiting coronary artery bypass grafting (CABG).
Detailed description
The recent emergence of platelet reactivity testing as a potential option for evaluating the degree of platelet inhibition promises to add another level of understanding to our concept of CABG-related bleeding. There is an emerging literature that links high levels of platelet reactivity with adverse clinical events, primarily in patients on clopidogrel. For example, studies of the VerifyNow P2Y12 platelet function assay have shown that Platelet Reactivity Units (PRU) \> 235-240 in patients on clopidogrel therapy appears to predict cardiovascular events.15,16 There is a paucity of literature, however, on the use of platelet reactivity testing to predict bleeding events and complications. In other words, if excessively high levels of platelet reactivity predict ischemic events, do excessively low levels of platelet reactivity predict bleeding events? This is an especially relevant question, given the emergence of prasugrel as a therapeutic option. The investigators therefore propose an exploratory cohort study of patients receiving a thienopyridine (clopidogrel or prasugrel) and undergoing CABG, in order to describe levels of platelet reactivity in such patients by using a variety of platelet function tests.
Conditions
- Complication of Coronary Artery Bypass Graft
- Peri-operative Hemorrhage or Hematoma
- Post Operative Bleeding
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Platelet reactivity assessment | Platelet reactivity, as measured by the Chrono-log Lumi-Aggregometer, VerifyNow P2Y12 assay, and Vasodilator Stimulated Phosphoprotein (VASP) flow cytometry assay. |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2016-02-01
- Completion
- 2016-07-01
- First posted
- 2011-08-01
- Last updated
- 2021-03-16
Source: ClinicalTrials.gov record NCT01406483. Inclusion in this directory is not an endorsement.