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).

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Dalteparin

Detailed Description

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• Study Type: Observational
• Enrollment (Actual): 618

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380 051
      • Pfizer Investigational Site
    • Surat, Gujarat, India, 395004
      • Pfizer Investigational Site
  • Haryana
    • Hissar, Haryana, India, 125 001
      • Pfizer Investigational Site
    • Hissar, Haryana, India, 125005
      • Pfizer Investigational Site
  • Karnataka
    • Bangalore, Karnataka, India, 562114
      • Pfizer Investigational Site
    • Manglore, Karnataka, India, 575 018
      • Pfizer Investigational Site
    • Mysore, Karnataka, India, 570 020
      • Pfizer Investigational Site
  • Maharahtra
    • Nagpur, Maharahtra, India, 440017
      • Pfizer Investigational Site
    • Nashik, Maharahtra, India, 3
      • Pfizer Investigational Site
  • Maharashtra
    • Ambernath (E), Maharashtra, India, 421501
      • Pfizer Investigational Site
    • Nagpur, Maharashtra, India, 440012
      • Pfizer Investigational Site
    • Nagpur, Maharashtra, India, 440 001
      • Pfizer Investigational Site
    • Nagpur, Maharashtra, India, 440 010
      • Pfizer Investigational Site
    • Nagpur, Maharashtra, India, 440033
      • Pfizer Investigational Site
    • Nashik, Maharashtra, India, 422 002
      • Pfizer Investigational Site
    • Nashik, Maharashtra, India, 422 009
      • Pfizer Investigational Site
    • Nashik Road, Maharashtra, India, 422 002
      • Pfizer Investigational Site
    • Nashik Road, Maharashtra, India, 422 101
      • Pfizer Investigational Site
    • Thane, Maharashtra, India
      • Pfizer Investigational Site
  • Rajasthan
    • Bikaner, Rajasthan, India, 334003
      • Pfizer Investigational Site
    • Jaipur, Rajasthan, India, 302 012
      • Pfizer Investigational Site
    • Jaipur, Rajasthan, India, 302019
      • Pfizer Investigational Site
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600 035
      • Pfizer Investigational Site
  • West Bengal
    • Kolkata, West Bengal, India, 700 019
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1.0	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline to 28 days after last dose of study drug
Number of Participants With Minor Bleeding Events	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.	Baseline to 28 days after last dose of study drug

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Stroke	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).	Baseline to 28 days after last dose of study drug
Number of Participants With Cardiac Arrest- Resuscitated	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.	Baseline to 28 days after last dose of study drug
Number of Participants With Heparin Induced Thrombocytopenia	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.	Baseline to 28 days after last dose of study drug

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: June 16, 2009
• First Submitted That Met QC Criteria: June 16, 2009
• First Posted (Estimate): June 17, 2009

Study Record Updates

• Last Update Posted (Estimate): January 23, 2012
• Last Update Submitted That Met QC Criteria: January 19, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: dalteparin non-ST segment elevated acute coronary syndromes
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
• Other Study ID Numbers: A6301088