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A Comparison of Certoparin and Unfractionated Heparin in the Prevention of Thromboembolic Events in Acutely Ill Medical Patients

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ClinicalTrials.gov Identifier: NCT00451412
Recruitment Status : Completed
First Posted : March 23, 2007
Last Update Posted : July 25, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
This study is designed to provide efficacy and safety data for certoparin in the prophylaxis of venous thromboembolism in immobilized, acutely ill medical patients.

Condition or disease Intervention/treatment Phase
Thromboembolism Drug: Certoparin Drug: Unfractionated Heparin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Multi-center Comparison of the Efficacy and Safety of Certoparin (3000 U Anti-Xa o.d.) With Unfractionated Heparin (5000 IU t.i.d.) in the Prophylaxis of Thromboembolic Events in Acutely Ill Medical Patients
Study Start Date : January 2007
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Certoparin Drug: Certoparin
3000 U anti XA of certoparin in 0.3 ml solution, once daily
Other Names:
  • Sandoparin
  • Embolex
  • low molecular weight heparin
Active Comparator: Unfractionated Heparin Drug: Unfractionated Heparin
solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily



Primary Outcome Measures :
  1. Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) [ Time Frame: 20 days ]

Secondary Outcome Measures :
  1. proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening, [ Time Frame: 20 days ]
  2. symptomatic DVT, [ Time Frame: 20 days ]
  3. symptomatic non-fatal pulmonary embolism (PE), [ Time Frame: 20 days ]
  4. combination of proximal DVT, non fatal PE and death from all causes including PE [ Time Frame: 20 days ]
  5. VTE related death, [ Time Frame: 20 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Hospitalized medical patients 70 years of age or older
  2. Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances)
  3. written informed consent

Exclusion Criteria:

  1. immobilization longer than 3 days prior to randomization
  2. prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system
  3. expected major surgical or invasive procedure within the next 3 weeks after randomization
  4. LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization
  5. immobilization due to cast or fracture
  6. indication for anticoagulatory or thrombolytic therapy
  7. acute symptomatic DVT / PE
  8. known hypersensitivity to any of the study drugs or drugs with similar chemical structures
  9. Acute or history of heparin induced thrombocytopenia type II (HIT II)

Other protocol-defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451412


Locations
Germany
Novartis investigative sites
Nürnberg, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00451412     History of Changes
Other Study ID Numbers: CMEX839BDE03
First Posted: March 23, 2007    Key Record Dates
Last Update Posted: July 25, 2012
Last Verified: July 2012

Keywords provided by Novartis:
Venous thromboembolism
Medical patients
Heparin
Low molecular weight heparin
Deep vein thrombosis
Certoparin
Embolism and Thrombosis

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