Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients

This study has been terminated.
(See Detailed Description)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00445328
First received: March 7, 2007
Last updated: October 5, 2009
Last verified: October 2009
  Purpose

The purpose of this study is to compare the efficacy and safety of dalteparin vs unfractionated heparin for the prevention of VTE (Venous Thromboembolism) in hospitalized acutely ill medical patients.


Condition Intervention Phase
Venous Thromboembolism
Drug: Dalteparin (Fragmin)
Drug: Unfractionated heparin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective Randomized Phase IV Open Label Comparative Study Of Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Confirmed Thromboembolic Events [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
  • Composite of Objectively Verified Thromboembolic Events [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All Cause Mortality [ Time Frame: Day 14, Day 21 (End of Study) ] [ Designated as safety issue: Yes ]
  • Stroke - Ischemic or Hemorrhagic [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
  • Bleeding - Major or Minor [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
  • Allergic Reactions (Drug-related) [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
  • Thrombocytopenia [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]

Enrollment: 84
Study Start Date: June 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: B Drug: Unfractionated heparin
Unfractionated heparin 5000 IU thrice daily subcutaneously for 6-14 days.
Experimental: A Drug: Dalteparin (Fragmin)
Dalteparin 5000 IU once daily subcutaneously for 6-14 days.

Detailed Description:

The study was prematurely discontinued due to delay in overall study start-up and inability to meet pre-defined protocol recruitment milestones on June 30th, 2008. There were no safety concerns regarding the study in the decision to terminate the trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged greater than or equal to 18 years
  • Acute medical condition with a projected hospitalization of greater than or equal to 4 days and had less than or equal to 3 days of prior immobilization for more than two thirds of the day
  • Acute congestive heart failure Class III-IV per NHYA/ Acute respiratory failure not requiring mechanical ventilation or Both
  • Acute infection without septic shock/ Acute episode of inflammatory bowel disease/ Acute rheumatologic disorders/ Acute lumbar pain or sciatica or vertebral compression with at least one risk factor for VTE

Exclusion Criteria:

  • Contraindications to use of anticoagulants
  • Active bleeding or abnormal coagulation tests
  • Recent (less than 1 month) head injury, hemorrhagic stroke, cerebral tumor or intracranial aneurysm or ischemic stroke within the last month.
  • Major surgical or invasive procedure within the last month resulting in ongoing convalescence
  • Lumbar or spinal puncture within last 48 hours
  • S creatinine levels more than 2
  • On inotropic agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445328

Locations
India
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 068
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 054
Pfizer Investigational Site
Trichur, Kerala, India, 680 005
Pfizer Investigational Site
Indore, Madhya Pradesh, India, 452001
Pfizer Investigational Site
Chennai, Tamil Nadu, India, 600 006
Pfizer Investigational Site
Kolkata, West Bengal, India, 700 054
Pfizer Investigational Site
Kolkata, West Bengal, India, 700 029
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00445328     History of Changes
Other Study ID Numbers: A6301080
Study First Received: March 7, 2007
Results First Received: July 20, 2009
Last Updated: October 5, 2009
Health Authority: India: Institutional Review Board

Keywords provided by Pfizer:
hospitalised acutely medically ill patients; Venous Thromboembolism, Infection, Inflammatory Bowel Diseases, Heart Failure, Congestive, Sciatica

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Calcium heparin
Heparin
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 31, 2014