Phase II Study to Compare MDCO-2010 vs Placebo and Tranexamic Acid in Patients Undergoing Cardiac Surgery
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01530399 |
Recruitment Status :
Terminated
(Safety)
First Posted : February 9, 2012
Results First Posted : December 10, 2015
Last Update Posted : December 10, 2015
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bleeding | Drug: MDCO 1 Drug: MDCO 2 Drug: MDCO 3 Drug: MDCO 4 Drug: Tranexamic Acid Drug: Saline | Phase 2 |
This was a two-stage, double-blind, randomized, parallel-group, multicenter Phase II dose-selection study to compare antifibrinolytic MDCO-2010 vs tranexamic acid and placebo in reducing blood loss.
This study was designed to examine a broad range of doses to fully characterize the dose-response relationship between MDCO-2010 dose, plasma PK, PD, and clinical effects.
In Stage 1, 90 patients were to be enrolled into one of six treatment groups with 15 patients per group: four groups were to receive MDCO-2010, one group was to receive tranexamic acid, and one group was to receive placebo. Stage 2 was to be an expansion of Stage 1.
The study was terminated after 49 patients were enrolled into Stage 1.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Double-blind, Parallel Group, Dose-selection Study to Compare Antifibrinolytic MDCO-2010 vs. Placebo and Tranexamic Acid in Reducing Blood Loss in Patients Undergoing Primary Cardiac Surgery |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | November 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: MDCO 1
MDCO-2010: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
|
Drug: MDCO 1
MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
Other Name: MDCO-2010 |
Experimental: MDCO 2
MDCO-2010: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
|
Drug: MDCO 2
MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
Other Name: MDCO-2010 |
Experimental: MDCO 3
MDCO-2010: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
|
Drug: MDCO 3
MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
Other Name: MDCO-2010 |
Experimental: MDCO 4
MDCO-2010: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
|
Drug: MDCO 4
MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
Other Name: MDCO-2010 |
Placebo Comparator: Saline
Commercially available saline (0.9% NaCl solution)
|
Drug: Tranexamic Acid
Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
Other Name: TXA |
Active Comparator: Tranexamic acid
Tranexamic acid: 12 mg/kg loading dose; 5 mg/kg/h infusion; 0.556 mg/mL CPB priming
|
Drug: Saline
A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
Other Name: NaCl 0.9% |
- Chest Tube Drainage at 12 Hours After Surgery [ Time Frame: 12 hours post CABG ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- For Stage 1: Planned primary isolated CABG surgery
- For 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 AND if less than 65 years old with a negative pre-operative pregnancy test within 24 hours of surgery OR with medical history of hysterectomy or bilateral oophorectomy
- Written informed consent
Exclusion Criteria:
- 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 three months
- History of stroke or transient ischemic attack within 3 months prior to surgery
- History of deep venous thrombosis or pulmonary embolism
- 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 ration (INR) >1.5, or
- Hematocrit <36%, or
- aPTT >1.5 x 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
- Active liver disease defined as any known current infectious, neoplastic or metabolic pathology of the liver OR ALT or AST elevation >2x ULN or total bilirubin elevation >1.5x ULN at Screening
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530399
Germany | |
Charité Berlin | |
Berlin, Germany | |
Universitätsklinikum Bonn | |
Bonn, Germany | |
Universität Heidelberg | |
Heidelberg, Germany | |
Universität Leipzig - Herzzentrum | |
Leipzig, Germany | |
Switzerland | |
University Hospital/Inselspital Bern | |
Bern, Switzerland |
Principal Investigator: | Lars Englberger, PD DR. med | University Hospital Inselspital, Bern |
Responsible Party: | The Medicines Company |
ClinicalTrials.gov Identifier: | NCT01530399 |
Other Study ID Numbers: |
TMC-MDC-11-01 |
First Posted: | February 9, 2012 Key Record Dates |
Results First Posted: | December 10, 2015 |
Last Update Posted: | December 10, 2015 |
Last Verified: | November 2015 |
Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents |
Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |