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NCT00311753 Clinical Trial

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

Embolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00311753
Other study ID # CMEX839BDE02
Secondary ID
Status Completed
Phase Phase 3
First received April 4, 2006
Last updated February 22, 2017
Start date February 2006

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 342
Est. completion date
Est. primary completion date December 2007
Accepts healthy volunteers
Gender All
Age group 40 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Certoparin
Low-molecular-weight heparin, Certoparin (3000 U anti-Xa once daily) treatment period of 10 ± 2 days
• Heparin
7500 IU of unfractionated heparin administered twice daily during the treatment period of 10 ± 2 days

Locations
Country Name City State
Switzerland Novartis Pharmaceuticals Basel

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

Schellong SM, Haas S, Greinacher A, Schwanebeck U, Sieder C, Abletshauser C, Bramlage P, Riess H. An open-label comparison of the efficacy and safety of certoparin versus unfractionated heparin for the prevention of thromboembolic complications in acutely — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The occurrence of thromboembolic events (proximal or distal DVT, PE or VTE related death) during treatment 10 ± 2 days
Secondary Thromboembolic events during follow-up period of 3 months 90 days (± 7 days) after the end of the treatment
Secondary Safety endpoints occurring during the treatment period: Hemorrhage (major or minor), Thrombocytopenia, Symptomatic HIT type II, Induction of HIT-II specific antibodies 10 ± 2 days
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