CompletedNot Applicable

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

75 participantsStarted 2010-08

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Serial levels of platelet reactivity, as assessed with the Chrono-log Lumi-Aggregometer

Timeframe: Duration of hospital stay; average hospital stay of 1 week

Perioperative rates of bleeding complications

Timeframe: Duration of hospital stay; average hospital stay of 1 week

Trial details

NCT IDNCT01406483

SponsorMedstar Health Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-02

View on ClinicalTrials.gov More Complication of Coronary Artery Bypass Graft trials