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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00311753
First received: April 4, 2006
Last updated: June 7, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Embolism
Drug: Certoparin
Drug: Heparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • The occurrence of thromboembolic events (proximal or distal DVT, PE or VTE related death) during treatment [ Time Frame: 10 ± 2 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Thromboembolic events during follow-up period of 3 months [ Time Frame: 90 days (± 7 days) after the end of the treatment ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 342
Study Start Date: February 2006
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Certoparin
Drug: Certoparin
Low-molecular-weight heparin, Certoparin (3000 U anti-Xa once daily) treatment period of 10 ± 2 days
Active Comparator: 2
Heparin
Drug: Heparin
7500 IU of unfractionated heparin administered twice daily during the treatment period of 10 ± 2 days

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Criteria

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

  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: NCT00311753

Locations
Germany
Investigative Centers, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00311753     History of Changes
Other Study ID Numbers: CMEX839BDE02
Study First Received: April 4, 2006
Last Updated: June 7, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
heparin, thromboprophylaxis, medical patients, acutely ill
Acutely ill non surgical patients
Immobilization

Additional relevant MeSH terms:
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Calcium heparin
Certoparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
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 August 01, 2014