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

Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451412
• Other study ID #: CMEX839BDE03
• Status: Completed
• Phase: Phase 3
• First received: March 21, 2007
• Last updated: July 24, 2012
• Start date: January 2007
• Est. completion date: June 2009

Study information

• Verified date: July 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesRomania: National Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3254
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thromboembolism

Intervention

Drug:
• Certoparin
3000 U anti XA of certoparin in 0.3 ml solution, once daily
• Unfractionated Heparin
solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily

Locations

Country	Name	City	State
Germany	Novartis investigative sites	Nürnberg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism)		20 days	No
Secondary	proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening,		20 days	No
Secondary	symptomatic DVT,		20 days	No
Secondary	symptomatic non-fatal pulmonary embolism (PE),		20 days	No
Secondary	combination of proximal DVT, non fatal PE and death from all causes including PE		20 days	No
Secondary	VTE related death,		20 days	No