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NCT Number: NCT00451412

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

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

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Key information

Conditions

Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis investigative sites

Nuremberg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Certoparin

Drug

3000 U anti XA of certoparin in 0.3 ml solution, once daily

Other names: Sandoparin, Embolex, low molecular weight heparin

Unfractionated heparin

Drug

solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily

Primary outcomes

  1. Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism)

    Time frame: 20 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 23, 2007
Registry last updated
Jul 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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