N/A
N=617
Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice
Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00922766 ↗Enrolled (actual)
617
Serious AEs
0.7%
Results posted
Nov 2011
Primary outcome: Primary: Number of Participants With Death or Myocardial Infarction (MI) — 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Dalteparin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Death or Myocardial Infarction (MI) |
3 | — |
| PRIMARY Number of Participants With Major Bleeding Events |
— | — |
| PRIMARY Number of Participants With Minor Bleeding Events |
1 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT00922766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.