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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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 Summary: t
Sponsor: Pfizer

Current Primary Outcome:

  • 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:

  • 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 ]


Current Secondary Outcome:

Original Secondary Outcome:

  • 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 ]


Information By: Pfizer

Dates:
Date Received: June 16, 2009
Date Started: May 2009
Date Completion:
Last Updated: January 19, 2012
Last Verified: January 2012