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

Tracking Information
First Submitted Date	June 16, 2009
First Posted Date	June 17, 2009
Results First Submitted Date	October 7, 2011
Results First Posted Date	November 11, 2011
Last Update Posted Date	January 23, 2012
Study Start Date	May 2009
Actual Primary Completion Date	September 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: October 7, 2011)	Number of Participants With Death or Myocardial Infarction (MI) [ Time Frame: Baseline to 28 days after last dose of study drug ]; Number of Participants With Major Bleeding Events [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures; (submitted: June 16, 2009)	Major bleeding [ Time Frame: end of index hospitalization ]; Minor bleeding [ Time Frame: end of index hospitalization ]; Death and myocardial infarction [ Time Frame: end of index hospitalization ]
Change History	Complete list of historical versions of study NCT00922766 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures; (submitted: June 16, 2009)	Stroke [ Time Frame: end of index hospitalization ]; Cardiac arrest - resuscitated [ Time Frame: end of index hospitalization ]; Heparin induced thrombocytopenia [ Time Frame: end of index hospitalization ]
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice
Official Title	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	t
Study Type	Observational
Study Design	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	Acute Coronary Syndrome
Intervention	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 Groups/Cohorts	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	Completed
Actual Enrollment; (submitted: October 7, 2011)	618
Original Estimated Enrollment; (submitted: June 16, 2009)	1650
Actual Study Completion Date	September 2010
Actual Primary Completion Date	September 2010 (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	India
Removed Location Countries
Administrative Information
NCT Number	NCT00922766
Other Study ID Numbers	A6301088
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Pfizer
Study Sponsor	Pfizer
Collaborators	Not Provided
Investigators	Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account	Pfizer
Verification Date	January 2012