Back to resultsPlatelet Reactivity in Patients on a Thienopyridine and Awaiting Coronary Artery Bypass Grafting (Serial CABG)
Primary Purpose
Complication of Coronary Artery Bypass Graft, Peri-operative Hemorrhage or Hematoma, Post Operative Bleeding
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Platelet reactivity assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Complication of Coronary Artery Bypass Graft focused on measuring Platelet reactivity, CABG, Perioperative and in hospital bleeding
Eligibility Criteria
Inclusion Criteria:
- Patients ≥ 18 years old from both genders.
- Taking maintenance thienopyridine therapy within 5 days of surgery OR received a loading dose of thienopyridine therapy within 48 hours of surgery for CABG.
- Referred for CABG (which is scheduled to be performed during the current admission).
Exclusion Criteria:
- Known allergies to aspirin, clopidogrel, or prasugrel.
- Use of a glycoprotein (GP) IIb/IIIa inhibitor within 8 hours of initial platelet reactivity testing.
- 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 initial blood draw.
- Hematocrit <25% the day of initial blood draw.
- On warfarin therapy at the time of initial blood draw.
- Known blood transfusion within the preceding 10 days of the blood draw.
- Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.
- Plan for patient to be discharged before undergoing CABG.
- Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CABG
Arm Description
Outcomes
Primary Outcome Measures
Serial levels of platelet reactivity, as assessed with the Chrono-log Lumi-Aggregometer
Serial levels of platelet reactivity, as assessed with the Chrono-log Lumi-Aggregometer, which measures levels of light transmittance after stimulation with ADP to estimate levels of platelet aggregation
Perioperative rates of bleeding complications
Perioperative rates of bleeding complications:
need for reoperation because of bleeding
need for perioperative red blood cell transfusion (units of packed red blood cells)
rates of TIMI, GUSTO, and nuisance bleeding
quantity of postoperative drainage (mL)
Secondary Outcome Measures
Serial levels of platelet reactivity, as assessed with the VerifyNow P2Y12 assay
Serial levels of platelet reactivity, as assessed with the VerifyNow P2Y12 assay, which measures platelet reactivity units (PRUs)
Serial levels of platelet reactivity, as assessed with the Vasodilator Stimulated Phosphoprotein (VASP) assay
Serial levels of platelet reactivity, as assessed with the Vasodilator Stimulated Phosphoprotein (VASP) assay, which measures percentage of platelet reactivity inhibition (PRI) by flow cytometry of the VASP-P protein
Full Information
NCT ID
NCT01406483
First Posted
July 22, 2011
Last Updated
March 11, 2021
Sponsor
Medstar Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01406483
Brief Title
Platelet Reactivity in Patients on a Thienopyridine and Awaiting Coronary Artery Bypass Grafting
Acronym
Serial CABG
Official Title
Platelet Reactivity in Patients on a Thienopyridine and Awaiting Coronary Artery Bypass Grafting
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 2010 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complication of Coronary Artery Bypass Graft, Peri-operative Hemorrhage or Hematoma, Post Operative Bleeding
Keywords
Platelet reactivity, CABG, Perioperative and in hospital bleeding
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CABG
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Platelet reactivity assessment
Intervention Description
Platelet reactivity, as measured by the Chrono-log Lumi-Aggregometer, VerifyNow P2Y12 assay, and Vasodilator Stimulated Phosphoprotein (VASP) flow cytometry assay.
Primary Outcome Measure Information:
Title
Serial levels of platelet reactivity, as assessed with the Chrono-log Lumi-Aggregometer
Description
Serial levels of platelet reactivity, as assessed with the Chrono-log Lumi-Aggregometer, which measures levels of light transmittance after stimulation with ADP to estimate levels of platelet aggregation
Time Frame
Duration of hospital stay; average hospital stay of 1 week
Title
Perioperative rates of bleeding complications
Description
Perioperative rates of bleeding complications:
need for reoperation because of bleeding
need for perioperative red blood cell transfusion (units of packed red blood cells)
rates of TIMI, GUSTO, and nuisance bleeding
quantity of postoperative drainage (mL)
Time Frame
Duration of hospital stay; average hospital stay of 1 week
Secondary Outcome Measure Information:
Title
Serial levels of platelet reactivity, as assessed with the VerifyNow P2Y12 assay
Description
Serial levels of platelet reactivity, as assessed with the VerifyNow P2Y12 assay, which measures platelet reactivity units (PRUs)
Time Frame
Duration of hospital stay; average hospital stay of 1 week
Title
Serial levels of platelet reactivity, as assessed with the Vasodilator Stimulated Phosphoprotein (VASP) assay
Description
Serial levels of platelet reactivity, as assessed with the Vasodilator Stimulated Phosphoprotein (VASP) assay, which measures percentage of platelet reactivity inhibition (PRI) by flow cytometry of the VASP-P protein
Time Frame
Duration of hospital stay; average hospital stay of 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients ≥ 18 years old from both genders.
Taking maintenance thienopyridine therapy within 5 days of surgery OR received a loading dose of thienopyridine therapy within 48 hours of surgery for CABG.
Referred for CABG (which is scheduled to be performed during the current admission).
Exclusion Criteria:
Known allergies to aspirin, clopidogrel, or prasugrel.
Use of a glycoprotein (GP) IIb/IIIa inhibitor within 8 hours of initial platelet reactivity testing.
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 initial blood draw.
Hematocrit <25% the day of initial blood draw.
On warfarin therapy at the time of initial blood draw.
Known blood transfusion within the preceding 10 days of the blood draw.
Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.
Plan for patient to be discharged before undergoing CABG.
Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.
12. IPD Sharing Statement
Learn more about this trial
Platelet Reactivity in Patients on a Thienopyridine and Awaiting Coronary Artery Bypass Grafting
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