Cardiopulmonary Bypass Clinical Trial
Official title:
A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDCO-2010 in Patients Undergoing Elective CABG Surgery
Verified date | June 2012 |
Source | The Medicines Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | June 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 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 e-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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Medicines Company |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Adverse Events | Number of patients experiencing Adverse Events | 7 days (day of surgery to day 7) | Yes |
Primary | Incidence of Serious Adverse Events | Number of patients experiencing Serious Adverse Events | 7 days (day of surgery to day 7) | Yes |
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