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
  Purpose

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).


Condition Intervention
Acute Coronary Syndrome
Drug: Dalteparin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Enrollment: 618
Study Start Date: May 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).

Detailed Description:

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922766

Locations
India
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 051
Pfizer Investigational Site
Surat, Gujarat, India, 395004
Pfizer Investigational Site
Hissar, Haryana, India, 125005
Pfizer Investigational Site
Hissar, Haryana, India, 125 001
Pfizer Investigational Site
Bangalore, Karnataka, India, 562114
Pfizer Investigational Site
Manglore, Karnataka, India, 575 018
Pfizer Investigational Site
Mysore, Karnataka, India, 570 020
Pfizer Investigational Site
Nagpur, Maharahtra, India, 440017
Pfizer Investigational Site
Nashik, Maharahtra, India, 3
Pfizer Investigational Site
Ambernath (E), Maharashtra, India, 421501
Pfizer Investigational Site
Nagpur, Maharashtra, India, 440 010
Pfizer Investigational Site
Nagpur, Maharashtra, India, 440 001
Pfizer Investigational Site
Nagpur, Maharashtra, India, 440033
Pfizer Investigational Site
Nagpur, Maharashtra, India, 440012
Pfizer Investigational Site
Nashik, Maharashtra, India, 422 009
Pfizer Investigational Site
Nashik, Maharashtra, India, 422 002
Pfizer Investigational Site
Nashik Road, Maharashtra, India, 422 101
Pfizer Investigational Site
Nashik Road, Maharashtra, India, 422 002
Pfizer Investigational Site
Thane, Maharashtra, India
Pfizer Investigational Site
Bikaner, Rajasthan, India, 334003
Pfizer Investigational Site
Jaipur, Rajasthan, India, 302019
Pfizer Investigational Site
Jaipur, Rajasthan, India, 302 012
Pfizer Investigational Site
Chennai, Tamil Nadu, India, 600 035
Pfizer Investigational Site
Kolkata, West Bengal, India, 700 019
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00922766     History of Changes
Other Study ID Numbers: A6301088
Study First Received: June 16, 2009
Results First Received: October 7, 2011
Last Updated: January 19, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Pfizer:
dalteparin non-ST segment elevated acute coronary syndromes

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Disease
Pathologic Processes
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 16, 2014