CompletedPhase 2

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDCO-2010 in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery

32 participantsStarted 2010-11

Plain-language summary

The purpose of this study is to demonstrate that periprocedural infusion of escalating doses of MDCO-2010 is safe and tolerated in patients undergoing elective CABG surgery, to characterize the single dose pharmacokinetics of MDCO-2010, to investigate the effect of MDCO-2010 on pharmacodynamics (biomarkers of fibrinolysis and coagulation parameters), and to investigate the effect on exploratory clinical endpoints of bleeding, transfusion requirements and reexploration.

Who can participate

Age range

18 Years – 80 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 * Men, aged 18 to 80 years or * Post-menopausal women, aged up to 80 years. Postmenopausal status defined as ≥ 1 year since last menstruation in women with no medical history of hysterectomy or women with a medical history of bilateral oophorectomy * Planned elective, isolated primary CABG surgery with more than 1 graft, including the use of cardiopulmonary bypass * Written informed consent prior to any study-related procedure not part of normal medical care Exclusion Criteria Patients may not meet any of the following exclusion criteria: * Planned concomitant surgery including atrial septal defect (ASD) repair, valve replacement, carotid endarterectomy, aortic surgery, any combined procedure or any repeat sternotomy * Planned Off-pump CABG * Body weight \< 55 kg or \> 110 kg * Planned hypothermia \< 28°C * Major surgical procedures within 30 days of entry * Placement of drug-eluting stent (DES) within 12 months or of bare-metal stent (BMS) within 6 weeks of entry in a vessel which is not intended to be grafted * Ejection fraction \< 35% * Preoperative coagulation abnormalities * Platelet count \< 100,000/cubic mm, or * INR \> 1.5 or Quick \< 40%, or * activated partial thromboplastin time (aPTT) \> 1.5 x upper limit of normal (ULN) * Preoperative Hb \< 11 g/dL for male patients or \< 10 g/dL for female patients * Patient refusal to receive donor blood products if necessary * Administration of thienopyridines within 5 days prior to surgery Admini…

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

Incidence of Adverse Events

Timeframe: 7 days (day of surgery to day 7)

Incidence of Serious Adverse Events

Timeframe: 7 days (day of surgery to day 7)

Trial details

NCT IDNCT01535222

SponsorThe Medicines Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-05

Results submitted2012-06-14

View on ClinicalTrials.gov More Coronary Artery Bypass Graft trials