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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 16, 2009

Last Updated Date

January 19, 2012

Start Date ^ICMJE

May 2009

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Death and myocardial infarction [ Time Frame: end of index hospitalization ] [ Designated as safety issue: No ]
Minor bleeding [ Time Frame: end of index hospitalization ] [ Designated as safety issue: Yes ]
Major bleeding [ Time Frame: end of index hospitalization ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00922766 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Stroke [ Time Frame: end of index hospitalization ] [ Designated as safety issue: Yes ]
Cardiac arrest - resuscitated [ Time Frame: end of index hospitalization ] [ Designated as safety issue: Yes ]
Heparin induced thrombocytopenia [ Time Frame: end of index hospitalization ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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).

Condition ^ICMJE

Acute Coronary Syndrome

Intervention ^ICMJE

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).

Study Group/Cohort (s)

1.0

Intervention: Drug: Dalteparin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

618

Completion Date

September 2010

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

India

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00922766

Other Study ID Numbers ^ICMJE

A6301088

Has Data Monitoring Committee

Yes

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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