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OpenTrials
Completed

NCT Number: NCT00311753

Efficacy and Safety of Low-molecular Weight Heparin for Thromboprophylaxis in Acutely Ill Medical Patients

Acutely ill immobilized patients are at a high risk for thromboembolic events including deep venous thrombosis or pulmonary embolism. Unfractionated heparin (UFH) and low molecular weight heparins (LMWH) are thought to be effective in preventing thromboembolic events. This study is designed to provide efficacy and safety data for thromboprophylaxis with the LMWH certoparin in comparison to thromboprophylaxis with UFH in acutely ill non-surgical patients.

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Key information

Conditions

Embolism Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Centers, Germany

Loading trial locations.

Who can participate

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

Inclusion criteria

  • Hospitalization due to an acute non-surgical disease
  • Significant decrease in mobility

Exclusion criteria

  • Indication for anticoagulant or thrombolytic therapy
  • Major surgical or invasive procedure within the 4 weeks that precede randomization
  • Expected major surgical or invasive procedure (including spinal/peridural/epidural anesthesia or lumbar puncture) within the 2 weeks that follow the randomization
  • Immobilization due to cast or fracture of lower extremity
  • Immobilization lasting longer than 3 days in the period prior to randomization
  • Heparin administration longer than 36 hours in the period prior to randomization
  • Acute ischemic stroke

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Certoparin

Drug

Low-molecular-weight heparin, Certoparin (3000 U anti-Xa once daily) treatment period of 10 ± 2 days

Heparin

Drug

7500 IU of unfractionated heparin administered twice daily during the treatment period of 10 ± 2 days

Primary outcomes

  1. The occurrence of thromboembolic events (proximal or distal DVT, PE or VTE related death) during treatment

    Time frame: 10 ± 2 days

Secondary outcomes

  1. Thromboembolic events during follow-up period of 3 months

    Time frame: 90 days (± 7 days) after the end of the treatment

  2. Safety endpoints occurring during the treatment period: Hemorrhage (major or minor), Thrombocytopenia, Symptomatic HIT type II, Induction of HIT-II specific antibodies

    Time frame: 10 ± 2 days

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Open-label Comparison of the Efficacy and Safety of the Low-molecular-weight Heparin (3000 U Anti-Xa Once Daily) With Unfractionated Heparin for the Prevention of Thromboembolic Complications in Acutely Ill Non-surgical Patients

Important dates

Study start
2006
Primary completion
2007
First posted
Apr 6, 2006
Registry last updated
Feb 24, 2017

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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