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

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Dalteparin

• Registration Number: NCT00922766
• Lead Sponsor: Pfizer

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

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Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-17
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2011-10-07
• Results First Submitted QC: 2011-10-07
• Results First Posted: 2011-11-11
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-19
• Last Update Posted: 2012-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 618

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1.0	Dalteparin	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Death or Myocardial Infarction (MI)	Baseline to 28 days after last dose of study drug
Number of Participants With Major Bleeding Events	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	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇮🇳 Kolkata, West Bengal, India