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

Primary Purpose

Embolism

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Certoparin

Heparin

About this trial

This is an interventional prevention trial for Embolism focused on measuring heparin, thromboprophylaxis, medical patients, acutely ill, Acutely ill non surgical patients, Immobilization

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

Novartis Pharmaceuticals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Certoparin

Heparin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Thromboembolic events during follow-up period of 3 months

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

Full Information

NCT ID

NCT00311753

First Posted

April 4, 2006

Last Updated

February 22, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00311753

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

February 2006 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Embolism

Keywords

heparin, thromboprophylaxis, medical patients, acutely ill, Acutely ill non surgical patients, Immobilization

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

342 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Certoparin

Arm Title

Arm Type

Active Comparator

Arm Description

Heparin

Intervention Type

Drug

Intervention Name(s)

Certoparin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Heparin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

10 ± 2 days

Secondary Outcome Measure Information:

Title

Thromboembolic events during follow-up period of 3 months

Time Frame

90 days (± 7 days) after the end of the treatment

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

City

Investigative Centers

Country

Germany

Facility Name

Novartis Pharmaceuticals

City

Basel

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

20950224

Citation

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 ill medical patients: CERTAIN. Expert Opin Pharmacother. 2010 Dec;11(18):2953-61. doi: 10.1517/14656566.2010.521498. Epub 2010 Oct 18.

Results Reference

result

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

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