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

NCT00922766 | Completed Results DMC

• 1 other identifier: A6301088
• Study Type: observational
• Target: 618
• Locations: 1 country
• Sites: 24

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).

Conditions

Acute Coronary Syndrome

Keywords

dalteparin non-ST segment elevated acute coronary syndromes

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Death or Myocardial Infarction (MI)

  Baseline to 28 days after last dose of study drug

• 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

• 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

Other Outcomes (3)

• Number of Participants With Stroke

  Baseline to 28 days after last dose of study drug

• Number of Participants With Cardiac Arrest- Resuscitated

  Baseline to 28 days after last dose of study drug

• Number of Participants With Heparin Induced Thrombocytopenia

  Baseline to 28 days after last dose of study drug

Study Arms (1)

1.0

Drug: Dalteparin

Interventions

Dalteparin DRUG

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).

1.0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• Patients who are contraindicated to receive this agent per the local approved prescribing information.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (24)

Pfizer Investigational Site

Ahmedabad, Gujarat, 380 051, India

Location

Pfizer Investigational Site

Surat, Gujarat, 395004, India

Location

Pfizer Investigational Site

Hisar, Haryana, 125 001, India

Location

Pfizer Investigational Site

Hisar, Haryana, 125005, India

Location

Pfizer Investigational Site

Bangalore, Karnataka, 562114, India

Location

Pfizer Investigational Site

Manglore, Karnataka, 575 018, India

Location

Pfizer Investigational Site

Mysore, Karnataka, 570 020, India

Location

Pfizer Investigational Site

Nagpur, Maharahtra, 440017, India

Location

Pfizer Investigational Site

Nashik, Maharahtra, 3, India

Location

Pfizer Investigational Site

Ambernath (E), Maharashtra, 421501, India

Location

Pfizer Investigational Site

Nagpur, Maharashtra, 440 001, India

Location

Pfizer Investigational Site

Nagpur, Maharashtra, 440 010, India

Location

Pfizer Investigational Site

Nagpur, Maharashtra, 440012, India

Location

Pfizer Investigational Site

Nagpur, Maharashtra, 440033, India

Location

Pfizer Investigational Site

Nashik, Maharashtra, 422 002, India

Location

Pfizer Investigational Site

Nashik, Maharashtra, 422 009, India

Location

Pfizer Investigational Site

Nashik Road, Maharashtra, 422 002, India

Location

Pfizer Investigational Site

Nashik Road, Maharashtra, 422 101, India

Location

Pfizer Investigational Site

Thane, Maharashtra, India

Location

Pfizer Investigational Site

Bikaner, Rajasthan, 334003, India

Location

Pfizer Investigational Site

Jaipur, Rajasthan, 302 012, India

Location

Pfizer Investigational Site

Jaipur, Rajasthan, 302019, India

Location

Pfizer Investigational Site

Chennai, Tamil Nadu, 600 035, India

Location

Pfizer Investigational Site

Kolkata, West Bengal, 700 019, India

Location

Related Links

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

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: May 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 23, 2012
• Results First Posted: November 11, 2011

Record last verified: 2012-01

Locations

IN (24)