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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922766
• Other study ID #: A6301088
• Status: Completed
• Phase: N/A
• First received: June 16, 2009
• Last updated: January 19, 2012
• Start date: May 2009
• Est. completion date: September 2010

Study information

• Verified date: January 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Description:

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Recruitment information / eligibility

• Status: Completed
• Enrollment: 618
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• 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).

Locations

Country	Name	City	State
India	Pfizer Investigational Site	Ahmedabad	Gujarat
India	Pfizer Investigational Site	Ambernath (E)	Maharashtra
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Bikaner	Rajasthan
India	Pfizer Investigational Site	Chennai	Tamil Nadu
India	Pfizer Investigational Site	Hissar	Haryana
India	Pfizer Investigational Site	Hissar	Haryana
India	Pfizer Investigational Site	Jaipur	Rajasthan
India	Pfizer Investigational Site	Jaipur	Rajasthan
India	Pfizer Investigational Site	Kolkata	West Bengal
India	Pfizer Investigational Site	Manglore	Karnataka
India	Pfizer Investigational Site	Mysore	Karnataka
India	Pfizer Investigational Site	Nagpur	Maharahtra
India	Pfizer Investigational Site	Nagpur	Maharashtra
India	Pfizer Investigational Site	Nagpur	Maharashtra
India	Pfizer Investigational Site	Nagpur	Maharashtra
India	Pfizer Investigational Site	Nagpur	Maharashtra
India	Pfizer Investigational Site	Nashik	Maharashtra
India	Pfizer Investigational Site	Nashik	Maharashtra
India	Pfizer Investigational Site	Nashik	Maharahtra
India	Pfizer Investigational Site	Nashik Road	Maharashtra
India	Pfizer Investigational Site	Nashik Road	Maharashtra
India	Pfizer Investigational Site	Surat	Gujarat
India	Pfizer Investigational Site	Thane	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Death or Myocardial Infarction (MI)		Baseline to 28 days after last dose of study drug	No
Primary	Number of Participants With Major Bleeding Events	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.	Baseline to 28 days after last dose of study drug	Yes
Primary	Number of Participants With Minor Bleeding Events	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.	Baseline to 28 days after last dose of study drug	Yes

External Links

•   To obtain contact information for a study center near you, click here.