Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDCO-2010 in Patients Undergoing E… (NCT01535222) | Clinical Trial Compass
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 range18 Years – 80 Years
SexALL
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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…