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Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00922766
First received: June 16, 2009
Last updated: January 19, 2012
Last verified: January 2012
Results First Received: October 7, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Acute Coronary Syndrome
Intervention: Drug: Dalteparin

  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
A total of 618 participants were screened, of which 617 participant were assigned to study treatment and 1 participant was excluded based on investigator's discretion.

Reporting Groups
  Description
Dalteparin Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.

Participant Flow:   Overall Study
    Dalteparin  
STARTED     617  
COMPLETED     610  
NOT COMPLETED     7  
Death                 3  
Withdrawal by Subject                 2  
Unspecified                 1  
Adverse Event                 1  



  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.
No text entered.

Reporting Groups
  Description
Dalteparin Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.

Baseline Measures
    Dalteparin  
Number of Participants  
[units: participants]
  617  
Age  
[units: years]
Mean ± Standard Deviation
  57.5  ± 12.6  
Gender  
[units: participants]
 
Female     249  
Male     368  



  Outcome Measures
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1.  Primary:   Number of Participants With Death or Myocardial Infarction (MI)   [ Time Frame: Baseline to 28 days after last dose of study drug ]

2.  Primary:   Number of Participants With Major Bleeding Events   [ Time Frame: Baseline to 28 days after last dose of study drug ]
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Measure Type Primary
Measure Title Number of Participants With Major Bleeding Events
Measure Description Bleeding events were considered major if, accompanied by a decrease in hemoglobin of more than or equal to 2 grams/deciliter (g/dL) in connection with clinical symptoms; a transfusion was required; bleeding led to interruption of treatment or death; or intracranial bleeding.
Time Frame Baseline to 28 days after last dose of study drug  
Safety Issue Yes  

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.
FAS included all enrolled participants who received at least 1 dose of the study medication.

Reporting Groups
  Description
Dalteparin Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.

Measured Values
    Dalteparin  
Number of Participants Analyzed  
[units: participants]
  617  
Number of Participants With Major Bleeding Events  
[units: Participants]
  0  

No statistical analysis provided for Number of Participants With Major Bleeding Events



3.  Primary:   Number of Participants With Minor Bleeding Events   [ Time Frame: Baseline to 28 days after last dose of study drug ]

4.  Other Pre-specified:   Number of Participants With Stroke   [ Time Frame: Baseline to 28 days after last dose of study drug ]

5.  Other Pre-specified:   Number of Participants With Cardiac Arrest- Resuscitated   [ Time Frame: Baseline to 28 days after last dose of study drug ]

6.  Other Pre-specified:   Number of Participants With Heparin Induced Thrombocytopenia   [ Time Frame: Baseline to 28 days after last dose of study drug ]


  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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