Phase 2
N=33
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDCO-2010 in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft · Cardiopulmonary Bypass
Bottom Line
View on ClinicalTrials.gov: NCT01535222 ↗Enrolled (actual)
33
Serious AEs
9.4%
Results posted
Jul 2012
Primary outcome: Primary: Incidence of Adverse Events — 3; 3; 5; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MDCO-2010 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Medicines Company
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events |
3; 3; 5; 4; 6; 7 | — |
| PRIMARY Incidence of Serious Adverse Events |
0; 0; 1; 0; 2; 0 | — |
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.
Eligibility Criteria
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 110 kg
- Planned hypothermia 1.5 or Quick 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 Administration of warfarin within 5 days prior to surgery
- Administration of tirofiban or eptifibatide within 24 hours or administration of abciximab within 5 days prior to surgery
- Administration of fondaparinux within 24 hours prior to surgery
- Creatinine clearance (calculated using Cockroft-Gault equation) < 60 mL/min
- Planned intraoperative use of tranexamic acid or of ε-aminocaproic acid
- History of stroke or transient ischemic attack within 3 months prior to entry
- Known heparin-induced thrombocytopenia
- Known history of thrombophilia, eg, deep vein thrombosis (DVT) with pulmonary embolism
- Active liver disease
- Any condition requiring chronic immunosuppressive medication
- Receipt of an investigational drug or device 30 days prior to entry
- Any other condition which, in the opinion of the investigator, would prevent a patient's participation in the study
Data sourced from ClinicalTrials.gov (NCT01535222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.