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European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial (EUROMAX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT01087723
First received: March 12, 2010
Last updated: January 13, 2016
Last verified: January 2016
Results First Received: January 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Coronary Syndrome
Interventions: Drug: Bivalirudin
Drug: 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bivalirudin Given immediately upon enrolment as an intravenous (IV) bolus of 0.75 milligrams/kilogram (mg/kg), followed immediately by an infusion of 1.75 mg/kg/hour (mg/kg/h). This infusion was to be run continuously until completion of percutaneous coronary intervention (PCI), at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
Standard of Care: Heparins With Optional GPI

Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of ST segment elevation acute coronary syndrome (STE-ACS ), not including bivalirudin: unfractionated heparin (UFH) (100 international units/kg [IU/kg] without glycoprotein IIb/IIIa inhibitor [GPI] and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-micrograms/kilogram [μg/kg] IV boluses with a 10-minute [min] interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).

For this study, the control consisted of treatment with UFH or low molecular weight heparin (LMWH) with or without GPI and is referred to as "heparins with optional GPI.”


Participant Flow:   Overall Study
    Bivalirudin     Standard of Care: Heparins With Optional GPI  
STARTED     1089 [1]   1109 [1]
Received at Least 1 Dose of Study Drug     1099 [2]   1094 [2]
COMPLETED     1075 [3]   1089 [3]
NOT COMPLETED     14     20  
1 Year Visit Too Early (<335 days)                 0                 1  
Withdrawal by Subject                 10                 13  
Physician Decision                 2                 0  
Lost to Follow-up                 1                 4  
Reason Not Specified                 1                 2  
[1] Randomized participants who signed an informed consent form (ICF); Intent-to-treat (ITT) population
[2] Participants who were randomized with signed ICF by treatment actually received; Safety population
[3] Completed 1-year follow-up in the study



  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.
Participants who were randomized and signed an ICF; ITT population

Reporting Groups
  Description
Bivalirudin Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
Standard of Care: Heparins With Optional GPI

Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).

For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as "heparins with optional GPI.”

Total Total of all reporting groups

Baseline Measures
    Bivalirudin     Standard of Care: Heparins With Optional GPI     Total  
Number of Participants  
[units: participants]
  1089     1109     2198  
Age  
[units: years]
Mean (Standard Deviation)
  61.4  (12.8)     62.0  (13.1)     61.7  (13.0)  
Gender  
[units: participants]
     
Female     275     248     523  
Male     814     861     1675  
Region of Enrollment  
[units: participants]
     
Austria     4     5     9  
Czech Republic     0     1     1  
Netherlands     377     391     768  
Denmark     78     72     150  
Poland     55     56     111  
Italy     31     41     72  
France     398     397     795  
Germany     139     140     279  
Slovenia     7     6     13  
Medical history: Participant Has Diabetes  
[units: participants]
  127     169     296  
Medical history: Participant Is a Current smoker (within past 30 days)  
[units: participants]
  453     472     925  
Medical history: Participant Has Hypertension  
[units: participants]
  459     504     963  
Medical history: Participant Has Hyperlipidemia [1]
[units: participants]
  398     417     815  
Medical history: Participant Has Had Previous myocardial infarction (MI)  
[units: participants]
  380     113     493  
[1] Participant has known hyperlipidemia or is on lipid-lowering drugs



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding   [ Time Frame: Within 30 days ]

2.  Secondary:   The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding   [ Time Frame: Within 30 days ]

3.  Secondary:   The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR)   [ Time Frame: Within 30 days ]

4.  Secondary:   The Incidence of Death at 1 Year   [ Time Frame: Within 1 Year ]

5.  Secondary:   The Incidence of Major Bleeding: Thrombolysis in MI (TIMI) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO)   [ Time Frame: Within 30 days ]

6.  Secondary:   The Incidence of Minor Bleeding: TIMI and GUSTO   [ Time Frame: Within 30 days ]

7.  Secondary:   The Incidence of Stent Thrombosis (Academic Research Consortium [ARC Definition])   [ Time Frame: Within 30 days ]

8.  Secondary:   The Incidence of Thrombocytopenia   [ Time Frame: Within 30 days ]

9.  Secondary:   The Incidence of Stroke   [ Time Frame: Within 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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Global Health Science Center
Organization: The Medicines Company
phone: 800-388-1183


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT01087723     History of Changes
Other Study ID Numbers: TMC-BIV-08-03
Study First Received: March 12, 2010
Results First Received: January 13, 2016
Last Updated: January 13, 2016
Health Authority: Austria: Federal Office for Safety in Health Care