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.
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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 ]

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
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Time Frame No text entered.
Additional Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

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.

Other Adverse Events
    Dalteparin  
Total, other (not including serious) adverse events    
# participants affected / at risk     23/617  
Blood and lymphatic system disorders    
Anaemia * 1  
# participants affected / at risk     3/617 (0.49%)  
Gastrointestinal disorders    
Abdominal Pain * 1  
# participants affected / at risk     1/617 (0.16%)  
Abdominal Pain Lower * 1  
# participants affected / at risk     1/617 (0.16%)  
Gingival Bleeding * 1  
# participants affected / at risk     1/617 (0.16%)  
Toothache * 1  
# participants affected / at risk     1/617 (0.16%)  
Vomiting * 1  
# participants affected / at risk     1/617 (0.16%)  
General disorders    
Chest Pain * 1  
# participants affected / at risk     2/617 (0.32%)  
Chills * 1  
# participants affected / at risk     1/617 (0.16%)  
Pyrexia * 1  
# participants affected / at risk     3/617 (0.49%)  
Hepatobiliary disorders    
Hepatitis * 1  
# participants affected / at risk     1/617 (0.16%)  
Infections and infestations    
Lower Respiratory Tract Infections * 1  
# participants affected / at risk     1/617 (0.16%)  
Investigations    
Respiratory Rate * 1  
# participants affected / at risk     1/617 (0.16%)  
Musculoskeletal and connective tissue disorders    
Back Pain * 1  
# participants affected / at risk     1/617 (0.16%)  
Myalgia * 1  
# participants affected / at risk     1/617 (0.16%)  
Nervous system disorders    
Headache * 1  
# participants affected / at risk     3/617 (0.49%)  
Hemiplegia * 1  
# participants affected / at risk     1/617 (0.16%)  
Respiratory, thoracic and mediastinal disorders    
Cough * 1  
# participants affected / at risk     1/617 (0.16%)  
Skin and subcutaneous tissue disorders    
Pruritus Generalised * 1  
# participants affected / at risk     1/617 (0.16%)  
Vascular disorders    
Venous Thrombosis * 1  
# participants affected / at risk     1/617 (0.16%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 13.1



  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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