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

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ClinicalTrials.gov Identifier: NCT00922766
Recruitment Status : Completed
First Posted : June 17, 2009
Results First Posted : November 11, 2011
Last Update Posted : January 23, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date June 16, 2009
First Posted Date June 17, 2009
Results First Submitted Date October 7, 2011
Results First Posted Date November 11, 2011
Last Update Posted Date January 23, 2012
Study Start Date May 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 7, 2011)
  • Number of Participants With Death or Myocardial Infarction (MI) [ Time Frame: Baseline to 28 days after last dose of study drug ]
  • Number of Participants With Major Bleeding Events [ Time Frame: Baseline to 28 days after last dose of study drug ]
    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.
  • Number of Participants With Minor Bleeding Events [ Time Frame: Baseline to 28 days after last dose of study drug ]
    Bleeding events like hematuria, wound hematoma or injection site hematoma which did not fulfill the criteria for a major bleeding episode were classified as minor bleeding.
Original Primary Outcome Measures
 (submitted: June 16, 2009)
  • Major bleeding [ Time Frame: end of index hospitalization ]
  • Minor bleeding [ Time Frame: end of index hospitalization ]
  • Death and myocardial infarction [ Time Frame: end of index hospitalization ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: June 16, 2009)
  • Stroke [ Time Frame: end of index hospitalization ]
  • Cardiac arrest - resuscitated [ Time Frame: end of index hospitalization ]
  • Heparin induced thrombocytopenia [ Time Frame: end of index hospitalization ]
Current Other Pre-specified Outcome Measures
 (submitted: January 19, 2012)
  • Number of Participants With Stroke [ Time Frame: Baseline to 28 days after last dose of study drug ]
    Stroke was defined as a sudden, focal neurologic deficit that was not reversible within 24 hours and was not the result of any readily identifiable cause (for example, tumor or trauma).
  • Number of Participants With Cardiac Arrest- Resuscitated [ Time Frame: Baseline to 28 days after last dose of study drug ]
    Cardiac arrest resuscitated was defined as sudden cessation of cardiac activity so that the participant became unresponsive, with no normal breathing and no signs of circulation. Cardiac arrest was used to signify an event that was reversed, usually by cardio-pulmonary resuscitation (CPR) and/or defibrillation or cardioversion, or cardiac pacing.
  • Number of Participants With Heparin Induced Thrombocytopenia [ Time Frame: Baseline to 28 days after last dose of study drug ]
    Thrombocytopenia was defined as a disorder in which there is an abnormally low platelet count. A normal platelet count ranged from 150,000 to 450,000 platelets per micro liter of blood.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice
Official Title Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice
Brief Summary To collect data on safety and effectiveness of dalteparin in the management of non-ST segment elevated acute coronary syndromes in nursing home patients who will be treated conservatively (without percutaneous corornary intervention [PCI] or coronary artery bypass graft [CABG] within 48 hours).
Detailed Description t
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients management of non-ST segment elevated acute coronary syndromes in nursing home who will be treated conservatively (without percutaneous corornary intervention [PCI] or coronary artery bypass graft [CABG] within 48 hours).
Condition Acute Coronary Syndrome
Intervention Drug: Dalteparin
Patients prescribed dalteparin for non-ST segment elevated acute coronary syndromes in nursing home patients who will be treated conservatively (without corornary intervention [PCI] or coronary artery bypass graft [CABG] within 48 hours).
Study Groups/Cohorts 1.0
Intervention: Drug: Dalteparin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 7, 2011)
618
Original Estimated Enrollment
 (submitted: June 16, 2009)
1650
Actual Study Completion Date September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or female patients of 18 years or more presenting with chest pain will be potentially eligible for inclusion in the study if they satisfy the criteria for unstable coronary artery disease per the investigator's routine practice and have received at least one injection of Fragmin (dalteparin sodium) as part of routine clinical practice and is expected to be treated conservatively (without PCI or CABG within 48 hours) during the index hospitalization.
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

  • Patients who are contraindicated to receive this agent per the local approved prescribing information.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT00922766
Other Study ID Numbers A6301088
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2012