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ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial (ENDOMAX)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01913483
First Posted: August 1, 2013
Last Update Posted: May 30, 2017
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.
Information provided by (Responsible Party):
The Medicines Company
Results First Submitted: February 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Peripheral Endovascular Interventions
Bleeding
Interventions: Drug: Bivalirudin
Drug: Unfractionated Heparin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who were randomized into the trial, who received at least one dose of study drug (Safety Population), and underwent the index peripheral endovascular interventions (PEI) procedure were included in the modified Intent-to-Treat (mITT) Population. This was the primary population for analyses of the primary and secondary endpoints.

Reporting Groups
  Description
Bivalirudin Bivalirudin was administered as an intravenous (IV) bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 milligrams (mg)/kilogram [kg]) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/hour (h) (or 1 mg/kg/h for participants with an estimated glomerular filtration rate [eGFR] <30 milliliters per minute [mL/min]).
Unfractionated Heparin Unfractionated heparin (UFH) was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.

Participant Flow:   Overall Study
    Bivalirudin   Unfractionated Heparin
STARTED [1]   367   365 
Received at Least 1 Dose of Study Drug [2]   335   321 
COMPLETED [3]   346   343 
NOT COMPLETED   21   22 
Withdrawal by Subject                1                2 
Lost to Follow-up                6                3 
Death                14                17 
[1] All participants who were randomized to the study were included in the Intent-to-Treat Population.
[2] The 656 participants were the same participants for both the Safety Population and mITT Population.
[3] One participant in the Bivalirudin and UFH Arms each died before receiving study drug.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT Population: Participants who were randomized into the trial, received at least one dose of study drug, and underwent the index PEI procedure.

Reporting Groups
  Description
Bivalirudin Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
Unfractionated Heparin UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
Total Total of all reporting groups

Baseline Measures
   Bivalirudin   Unfractionated Heparin   Total 
Overall Participants Analyzed 
[Units: Participants]
 335   321   656 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.3  (10.3)   68.8  (10.3)   69.0  (10.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      133  39.7%      123  38.3%      256  39.0% 
Male      202  60.3%      198  61.7%      400  61.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      3   0.9%      1   0.3%      4   0.6% 
Asian      1   0.3%      2   0.6%      3   0.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      49  14.6%      40  12.5%      89  13.6% 
White      282  84.2%      278  86.6%      560  85.4% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   335   321   656 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Participants With Bleeding Academic Research Consortium Type 3 or Greater (BARC ≥3) Events Up to 48 h or at Hospital Discharge, As Adjudicated by the Independent Clinical Events Committee (CEC)   [ Time Frame: Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first ]

2.  Secondary:   Participants With Myocardial Infarction (MI), Stroke/Transient Ischemic Attack (TIA), Unplanned Repeat Revascularization (URV), Death, and Minor Bleeding Up to 48 h Post Study Drug Administration   [ Time Frame: Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first ]

3.  Secondary:   Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30   [ Time Frame: Study drug initiation (Day 1) up to 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Chief Medical Executive
Organization: Miami Cardiac & Vascular Institute, Baptist Health South Florida
phone: 800-273-2700
e-mail: MCVI@BaptistHealth.net



Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT01913483     History of Changes
Other Study ID Numbers: MDCO-BIV-12-03
First Submitted: July 30, 2013
First Posted: August 1, 2013
Results First Submitted: February 17, 2017
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017