- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00922766
Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice
January 19, 2012 updated by: Pfizer
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
Detailed Description
t
Study Type
Observational
Enrollment (Actual)
618
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gujarat
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Ahmedabad, Gujarat, India, 380 051
- Pfizer Investigational Site
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Surat, Gujarat, India, 395004
- Pfizer Investigational Site
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Haryana
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Hissar, Haryana, India, 125 001
- Pfizer Investigational Site
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Hissar, Haryana, India, 125005
- Pfizer Investigational Site
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Karnataka
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Bangalore, Karnataka, India, 562114
- Pfizer Investigational Site
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Manglore, Karnataka, India, 575 018
- Pfizer Investigational Site
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Mysore, Karnataka, India, 570 020
- Pfizer Investigational Site
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Maharahtra
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Nagpur, Maharahtra, India, 440017
- Pfizer Investigational Site
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Nashik, Maharahtra, India, 3
- Pfizer Investigational Site
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Maharashtra
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Ambernath (E), Maharashtra, India, 421501
- Pfizer Investigational Site
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Nagpur, Maharashtra, India, 440012
- Pfizer Investigational Site
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Nagpur, Maharashtra, India, 440 001
- Pfizer Investigational Site
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Nagpur, Maharashtra, India, 440 010
- Pfizer Investigational Site
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Nagpur, Maharashtra, India, 440033
- Pfizer Investigational Site
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Nashik, Maharashtra, India, 422 002
- Pfizer Investigational Site
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Nashik, Maharashtra, India, 422 009
- Pfizer Investigational Site
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Nashik Road, Maharashtra, India, 422 002
- Pfizer Investigational Site
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Nashik Road, Maharashtra, India, 422 101
- Pfizer Investigational Site
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Thane, Maharashtra, India
- Pfizer Investigational Site
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Rajasthan
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Bikaner, Rajasthan, India, 334003
- Pfizer Investigational Site
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Jaipur, Rajasthan, India, 302 012
- Pfizer Investigational Site
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Jaipur, Rajasthan, India, 302019
- Pfizer Investigational Site
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Tamil Nadu
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Chennai, Tamil Nadu, India, 600 035
- Pfizer Investigational Site
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West Bengal
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Kolkata, West Bengal, India, 700 019
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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1.0
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Death or Myocardial Infarction (MI)
Time Frame: Baseline to 28 days after last dose of study drug
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Baseline to 28 days after last dose of study drug
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Number of Participants With Major Bleeding Events
Time Frame: Baseline to 28 days after last dose of study drug
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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.
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Baseline to 28 days after last dose of study drug
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Number of Participants With Minor Bleeding Events
Time Frame: Baseline to 28 days after last dose of study drug
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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.
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Baseline to 28 days after last dose of study drug
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Stroke
Time Frame: Baseline to 28 days after last dose of study drug
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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).
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Baseline to 28 days after last dose of study drug
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Number of Participants With Cardiac Arrest- Resuscitated
Time Frame: Baseline to 28 days after last dose of study drug
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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.
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Baseline to 28 days after last dose of study drug
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Number of Participants With Heparin Induced Thrombocytopenia
Time Frame: Baseline to 28 days after last dose of study drug
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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.
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Baseline to 28 days after last dose of study drug
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- A6301088
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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