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Phase II Study to Compare MDCO-2010 vs Placebo and Tranexamic Acid in Patients Undergoing Cardiac Surgery

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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
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bleeding
Interventions Drug: MDCO 1
Drug: MDCO 2
Drug: MDCO 3
Drug: MDCO 4
Drug: Tranexamic Acid
Drug: Saline
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MDCO 1 MDCO 2 MDCO 3 MDCO 4 Saline Tranexamic Acid
Hide Arm/Group Description MDCO-2010 Dose 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 MDCO-2010 Dose 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 MDCO-2010 Dose 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 MDCO-2010 Dose 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 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. 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.
Period Title: Overall Study
Started 8 10 8 10 6 7
Completed 7 8 7 10 6 6
Not Completed 1 2 1 0 0 1
Arm/Group Title MDCO 1 MDCO 2 MDCO 3 MDCO 4 Saline Tranexamic Acid Total
Hide Arm/Group Description MDCO-2010 Dose 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 MDCO-2010 Dose 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 MDCO-2010 Dose 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 MDCO-2010 Dose 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 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 8 10 8 10 6 7 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 8 participants 10 participants 8 participants 10 participants 6 participants 7 participants 49 participants
71
(64 to 75)
70
(57 to 73)
66
(60 to 79)
73
(68 to 73)
66
(60 to 71)
58
(52 to 62)
69
(61 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 10 participants 8 participants 10 participants 6 participants 7 participants 49 participants
Female
1
  12.5%
2
  20.0%
1
  12.5%
2
  20.0%
2
  33.3%
0
   0.0%
8
  16.3%
Male
7
  87.5%
8
  80.0%
7
  87.5%
8
  80.0%
4
  66.7%
7
 100.0%
41
  83.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 10 participants 8 participants 10 participants 6 participants 7 participants 49 participants
Germany 6 7 5 7 4 4 33
Switzerland 2 3 3 3 2 3 16
1.Primary Outcome
Title Chest Tube Drainage at 12 Hours After Surgery
Hide Description [Not Specified]
Time Frame 12 hours post CABG
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MDCO 1 MDCO 2 MDCO 3 MDCO 4 Saline Tranexamic Acid
Hide Arm/Group Description:
MDCO-2010 Dose 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
MDCO-2010 Dose 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
MDCO-2010 Dose 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
MDCO-2010 Dose 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
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.
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.
Overall Number of Participants Analyzed 7 7 6 10 6 6
Median (Inter-Quartile Range)
Unit of Measure: mL
600
(300 to 970)
580
(420 to 880)
480
(350 to 700)
453
(415 to 645)
645
(400 to 1040)
593
(530 to 750)
Time Frame 30 (+5) days post treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MDCO 1 MDCO 2 MDCO 3 MDCO 4 Saline Tranexamic Acid
Hide Arm/Group Description MDCO-2010 Dose 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 MDCO-2010 Dose 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 MDCO-2010 Dose 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 MDCO-2010 Dose 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 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. 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.
All-Cause Mortality
MDCO 1 MDCO 2 MDCO 3 MDCO 4 Saline Tranexamic Acid
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
MDCO 1 MDCO 2 MDCO 3 MDCO 4 Saline Tranexamic Acid
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/7 (28.57%)   2/8 (25.00%)   1/7 (14.29%)   2/10 (20.00%)   0/6 (0.00%)   0/6 (0.00%) 
Blood and lymphatic system disorders             
Haemorrhagic anaemia  1  1/7 (14.29%)  0/8 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Cardiac disorders             
Cardiac tamponade  1  0/7 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Coronary artery occlusion  1  0/7 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Low cardiac output syndrome  1  0/7 (0.00%)  1/8 (12.50%)  1/7 (14.29%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications             
Vascular graft thrombosis  1  0/7 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nervous system disorders             
Ischaemic stroke  1  1/7 (14.29%)  0/8 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Renal and urinary disorders             
Renal failure  1  1/7 (14.29%)  0/8 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Respiratory failure  1  1/7 (14.29%)  0/8 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Vascular disorders             
Arterial thrombosis limb  1  0/7 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Extremity necrosis  1  1/7 (14.29%)  0/8 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Jugular vein thrombosis  1  0/7 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MDCO 1 MDCO 2 MDCO 3 MDCO 4 Saline Tranexamic Acid
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/7 (71.43%)   7/8 (87.50%)   4/7 (57.14%)   7/10 (70.00%)   5/6 (83.33%)   4/6 (66.67%) 
Blood and lymphatic system disorders             
Troponin T increased  1  1/7 (14.29%)  2/8 (25.00%)  1/7 (14.29%)  1/10 (10.00%)  0/6 (0.00%)  0/6 (0.00%) 
Cardiac disorders             
Atrial fibrillation  1  1/7 (14.29%)  2/8 (25.00%)  1/7 (14.29%)  2/10 (20.00%)  1/6 (16.67%)  2/6 (33.33%) 
Gastrointestinal disorders             
Nausea  1  2/7 (28.57%)  1/8 (12.50%)  0/7 (0.00%)  1/10 (10.00%)  2/6 (33.33%)  0/6 (0.00%) 
AST increased  1  0/7 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  2/6 (33.33%) 
Hepatobiliary disorders             
AST increased  1  0/7 (0.00%)  2/8 (25.00%)  0/7 (0.00%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Renal and urinary disorders             
Urinary tract infection  1  0/7 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  2/10 (20.00%)  2/6 (33.33%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Pleural effusion  1  3/7 (42.86%)  2/8 (25.00%)  1/7 (14.29%)  1/10 (10.00%)  1/6 (16.67%)  0/6 (0.00%) 
Pneumothorax  1  0/7 (0.00%)  2/8 (25.00%)  1/7 (14.29%)  0/10 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
After initial multicenter results communications are published, or after 12 months from study closure (whichever occurs first), sponsor can review results communications prior to submission and can embargo submissions for a period of 45 days from the time submitted to the sponsor for review, agreeing to resolve differences of opinion or interpretation through scientific debate. Sponsor can request further delay for an additional 90 days to file any patent applications if deemed necessary
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter Villiger
Organization: TMC
Phone: +19732906340
EMail: peter.villiger@themedco.com
Layout table for additonal information
Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT01530399    
Other Study ID Numbers: TMC-MDC-11-01
First Submitted: February 7, 2012
First Posted: February 9, 2012
Results First Submitted: November 4, 2015
Results First Posted: December 10, 2015
Last Update Posted: December 10, 2015