Clinical trial NCT00922766: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: dalteparin non-ST segment elevated acute coronary syndromes
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-17
Enrollment: 618
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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

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.

Primary outcomes:
measure: Number of Participants With Death or Myocardial Infarction (MI)
timeFrame: Baseline to 28 days after last dose of study drug
measure: Number of Participants With Major Bleeding Events
timeFrame: Baseline to 28 days after last dose of study drug
measure: Number of Participants With Minor Bleeding Events
timeFrame: Baseline to 28 days after last dose of study drug
Secondary outcomes:
Other outcomes:
measure: Number of Participants With Stroke
timeFrame: Baseline to 28 days after last dose of study drug
measure: Number of Participants With Cardiac Arrest- Resuscitated
timeFrame: Baseline to 28 days after last dose of study drug
measure: Number of Participants With Heparin Induced Thrombocytopenia
timeFrame: Baseline to 28 days after last dose of study drug
Locations:
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Surat
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Hissar
country: India
facility: Pfizer Investigational Site
state: Haryana
city: Hissar
country: India
facility: Pfizer Investigational Site
state: Haryana
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Manglore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Mysore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Nagpur
country: India
facility: Pfizer Investigational Site
state: Maharahtra
city: Nashik
country: India
facility: Pfizer Investigational Site
state: Maharahtra
city: Ambernath (E)
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Nagpur
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Nagpur
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Nagpur
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Nagpur
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Nashik Road
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Nashik Road
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Nashik
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Nashik
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Thane
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Bikaner
country: India
facility: Pfizer Investigational Site
state: Rajasthan
city: Jaipur
country: India
facility: Pfizer Investigational Site
state: Rajasthan
city: Jaipur
country: India
facility: Pfizer Investigational Site
state: Rajasthan
city: Chennai
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Kolkata
country: India
facility: Pfizer Investigational Site
state: West Bengal
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: