Platelet Reactivity in Patients on a Thienopyridine and Awaiting Coronary Artery Bypass Grafting

Complication of Coronary Artery Bypass Graft Clinical Trial

— Serial CABG  

Official title:

Platelet Reactivity in Patients on a Thienopyridine and Awaiting Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406483
• Other study ID #: Serial CABG
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Est. completion date: July 2016

Study information

• Verified date: June 2018
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients = 18 years old from both genders.

2. Taking maintenance thienopyridine therapy within 5 days of surgery OR received a loading dose of thienopyridine therapy within 48 hours of surgery for CABG.

3. Referred for CABG (which is scheduled to be performed during the current admission).

Exclusion Criteria:

1. Known allergies to aspirin, clopidogrel, or prasugrel.

2. Use of a glycoprotein (GP) IIb/IIIa inhibitor within 8 hours of initial platelet reactivity testing.

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 initial blood draw.

6. Hematocrit <25% the day of initial blood draw.

7. On warfarin therapy at the time of initial blood draw.

8. Known blood transfusion within the preceding 10 days of the blood draw.

9. Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.

10. Plan for patient to be discharged before undergoing CABG.

11. Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Complication of Coronary Artery Bypass Graft
• Hematoma
• Hemorrhage
• Peri-operative Hemorrhage or Hematoma
• Post Operative Bleeding
• Postoperative Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of hospital stay; average hospital stay of 1 week
Primary	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)	Duration of hospital stay; average hospital stay of 1 week
Secondary	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)	Duration of hospital stay; average hospital stay of 1 week
Secondary	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	Duration of hospital stay; average hospital stay of 1 week