Dose section Phase II study to compare the inhibition of blood loss in patients undergoing primary heart surgery and treatment with the investigational drug MDCO-2010, the active comparator tanexamic acid or placebo.
- Conditions
- Primary cardiac surgery involving cardiopulmonary bypassTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2011-004666-15-DE
- Lead Sponsor
- The Medicines Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
• In Stage 1: Planned primary isolated CABG surgery
• In Stage 2: Planned primary isolated CABG surgery, OR Planned primary combined CABG and aortic valve replacement surgery
• Men, aged 18 to 85 years, OR
Women, aged 18 to 85 years, either of postmenopausal status, defined as =1 year since last menstrual period, or with a medical history of hysterectomy or bilateral oophorectomy
•Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 135
•Off-pump surgery or hybrid procedures
•Patients undergoing repeat sternotomy
•Planned deep hypothermic circulatory arrest (<28°C)
•Known allergy, sensitivity or contraindications to tranexamic acid
•Epileptiform disorders, history of seizure activity or anticonvulsive medication
•Administration of clopidogrel, ticagrelor or ticlopidine within 5 days prior to surgery or prasugrel within 7 days prior to surgery
•Administration of low molecular weight heparin, glycoprotein IIb/IIIa inhibitors or fondaparinux within 12 hours prior to surgery
•Known history of coronary stent thrombosis within the last 3 months
•History of stroke or transient ischemic attack within 3 months prior to surgery
•Left ventricular ejection fraction (LVEF) =35% or Grade III or IV
•Body mass index <20 or >35
•Known active gastrointestinal (GI) or other non-catheterization bleeding within 7 days prior to surgery
•Preoperative coagulation abnormalities defined as:
–Platelet count <100,000/?L or >350,000/?L, or
–International normalized ratio (INR) >1.5, or
–Hematocrit <36%, or
–Activated partial thromboplastin time (aPTT) >1.5 x the upper limit of normal (ULN)
•Major surgical procedures within 30 days prior to surgery
•Patient inability or refusal to receive donor blood products if necessary
•Creatinine >2 mg/dL or estimated glomerular filtration rate (eGFR) (calculated using Modification of Diet in Renal Disease [MDRD] equation) <30 mL/min
•Known heparin-induced thrombocytopenia type II
•Known history of thrombophilia, such as AT-III, Protein C or Protein S deficiency, Factor V Leiden, anti-phospholipid syndrome
•Known active liver disease
•Any condition requiring ongoing chronic immunosuppressive medication
•Malignancy within 5 years prior to surgery
•Receipt of an investigational drug or device within 60 days prior to surgery
•Any other condition which, in the opinion of the Principal Investigator, would put the subject at increased risk from participating in the study or otherwise prevent a patient’s participation in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: safety;Primary end point(s): • Chest tube drainage 12 hours after surgery;Timepoint(s) of evaluation of this end point: 12 hours after surgery;Main Objective: The objective of this study is to determine the dose response relationship regarding blood loss, pharmacokinetics (PK), pharmacodynamics (PD), safety and clinical outcomes of MDCO-2010 vs. placebo and tranexamic acid in patients undergoing primary cardiac surgery
- Secondary Outcome Measures
Name Time Method