Complication of Coronary Artery Bypass GraftSerial CABGNCT01406483
Platelet Reactivity in Patients on a Thienopyridine and Awaiting Coronary Artery Bypass Grafting
A study testing Platelet reactivity assessment in people with Complication of Coronary Artery Bypass Graft and Peri-operative Hemorrhage or Hematoma, run by Medstar Health Research Institute.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Coronary Artery Bypass Graft, Peri-operative Hemorrhage or Hematoma, Post Operative Bleeding
- What is being tested?
- Platelet reactivity assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
About this study
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).
Read the 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
- Being tested
- Platelet reactivity assessment
- Keywords
- Platelet reactivity, CABG, Perioperative and in hospital bleeding
- Medical subject headings
- Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet reactivity assessmentOther
Platelet reactivity, as measured by the Chrono-log Lumi-Aggregometer, VerifyNow P2Y12 assay, and Vasodilator Stimulated Phosphoprotein (VASP) flow cytometry assay.
| Study group | Role | What they receive |
|---|---|---|
| CABG | Other | Not described Receives: Other: Platelet reactivity assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Duration of hospital stay; average hospital stay of 1 week
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)
Measured: Duration of hospital stay; average hospital stay of 1 week
Secondary outcomes (2)
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)
Measured: Duration of hospital stay; average hospital stay of 1 week
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
Measured: Duration of hospital stay; average hospital stay of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startAug 2010
- Primary completionFeb 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Coronary Artery Bypass GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406483
- Sponsor's protocol ID
- Serial CABG
- Acronym
- Serial CABG
- Status last verified
- Jun 2018
- First submitted
- 22 Jul 2011
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Reactivity in Patients on a Thienopyridine and Awaiting Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT01406483
- Acronym / sponsor ID
- Serial CABG / Serial CABG
- Conditions
- Complication of Coronary Artery Bypass Graft, Peri-operative Hemorrhage or Hematoma, Post Operative Bleeding
- Keywords
- Platelet reactivity, CABG, Perioperative and in hospital bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Aug 2010 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CABG | Other | Other: Platelet reactivity assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet reactivity assessmentPlatelet reactivity, as measured by the Chrono-log Lumi-Aggregometer, VerifyNow P2Y12 assay, and Vasodilator Stimulated Phosphoprotein (VASP) flow cytometry assay. | Other | CABG |
Primary outcome
Serial levels of platelet reactivity, as assessed with the Chrono-log Lumi-Aggregometer
Time frame: Duration of hospital stay; average hospital stay of 1 week
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
Time frame: Duration of hospital stay; average hospital stay of 1 week
Perioperative rates of bleeding complications: 1. need for reoperation because of bleeding 2. need for perioperative red blood cell transfusion (units of packed red blood cells) 3. rates of TIMI, GUSTO, and nuisance bleeding 4. quantity of postoperative drainage (mL)
2 secondary outcomes
Serial levels of platelet reactivity, as assessed with the VerifyNow P2Y12 assay
Time frame: Duration of hospital stay; average hospital stay of 1 week
Serial levels of platelet reactivity, as assessed with the Vasodilator Stimulated Phosphoprotein (VASP) assay
Time frame: Duration of hospital stay; average hospital stay of 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet reactivity assessment in people with Complication of Coronary Artery Bypass Graft and Peri-operative Hemorrhage or Hematoma, run by Medstar Health Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serial levels of platelet reactivity, as assessed with the Chrono-log Lumi-Aggregometer (time frame: Duration of hospital stay; average hospital stay of 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.