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Study on Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Percutaneous Coronary Intervention (PCI)

This study has been completed.
Sponsor:
Information provided by:
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00508924
First received: July 26, 2007
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
Results First Received: November 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Coronary Artery Disease
Angina, Unstable
Interventions: Drug: Argatroban
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
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Reporting Groups
  Description
ARG250

250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min

additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
ARG300

300μg/kg i.v. bolus followed by infusion of 20μg/kg/min

additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
ARG350

350μg/kg i.v. bolus followed by infusion of 25μg/kg/min

additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
Heparin

70-100 IU/kg i.v. bolus

additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec

Participant Flow:   Overall Study
    ARG250     ARG300     ARG350     Heparin  
STARTED     36     38     32     34  
COMPLETED     36     38     31     33  
NOT COMPLETED     0     0     1     1  
Protocol Violation                 0                 0                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
ARG250

250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min

additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
ARG300

300μg/kg i.v. bolus followed by infusion of 20μg/kg/min

additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
ARG350

350μg/kg i.v. bolus followed by infusion of 25μg/kg/min

additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec
Heparin

70-100 IU/kg i.v. bolus

additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec
Total Total of all reporting groups

Baseline Measures
    ARG250     ARG300     ARG350     Heparin     Total  
Number of Participants  
[units: participants]
 		  36     38     32     34     140  
Age  
[units: years]
Mean ± Standard Deviation 		  63.4  ± 8.9     65.5  ± 9.5     68.3  ± 7.9     65.9  ± 9.8     65.7  ± 9.2  
Gender  
[units: participants]
 		         
Female     11     8     9     5     33  
Male     25     30     23     29     107  



  Outcome Measures
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1.  Primary:   Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment.   [ Time Frame: 5 - 10 min after initial bolus ]
  Show Outcome Measure 1

2.  Primary:   Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.   [ Time Frame: 30 Days ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
e-mail: cti-inq-ml@ml.mt-pharma.co.jp


Publications of Results:


ClinicalTrials.gov Identifier: NCT00508924     History of Changes
Other Study ID Numbers: ARG-E04
Study First Received: July 26, 2007
Results First Received: November 6, 2012
Last Updated: November 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices