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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

June 16, 2009
January 19, 2012
May 2009
September 2010   (final data collection date for primary outcome measure)
  • Number of Participants With Death or Myocardial Infarction (MI) [ Time Frame: Baseline to 28 days after last dose of study drug ] [ Designated as safety issue: No ]
  • Number of Participants With Major Bleeding Events [ Time Frame: Baseline to 28 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.
  • Death and myocardial infarction [ Time Frame: end of index hospitalization ] [ Designated as safety issue: No ]
  • Minor bleeding [ Time Frame: end of index hospitalization ] [ Designated as safety issue: Yes ]
  • Major bleeding [ Time Frame: end of index hospitalization ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00922766 on ClinicalTrials.gov Archive Site
Not Provided
  • Stroke [ Time Frame: end of index hospitalization ] [ Designated as safety issue: Yes ]
  • Cardiac arrest - resuscitated [ Time Frame: end of index hospitalization ] [ Designated as safety issue: Yes ]
  • Heparin induced thrombocytopenia [ Time Frame: end of index hospitalization ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice
Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice

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).

t

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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).

Acute Coronary Syndrome
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).
1.0
Intervention: Drug: Dalteparin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
618
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00922766
A6301088
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP