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

Primary Purpose

Thromboembolism

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Certoparin

Unfractionated Heparin

About this trial

This is an interventional prevention trial for Thromboembolism focused on measuring Venous thromboembolism, Medical patients, Heparin, Low molecular weight heparin, Deep vein thrombosis, Certoparin, Embolism and Thrombosis

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Hospitalized medical patients 70 years of age or older
Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances)
written informed consent

Exclusion Criteria:

immobilization longer than 3 days prior to randomization
prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system
expected major surgical or invasive procedure within the next 3 weeks after randomization
LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization
immobilization due to cast or fracture
indication for anticoagulatory or thrombolytic therapy
acute symptomatic DVT / PE
known hypersensitivity to any of the study drugs or drugs with similar chemical structures
Acute or history of heparin induced thrombocytopenia type II (HIT II)

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

Novartis investigative sites

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Certoparin

Unfractionated Heparin

Arm Description

Outcomes

Primary Outcome Measures

Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism)

Secondary Outcome Measures

proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening,

symptomatic DVT,

symptomatic non-fatal pulmonary embolism (PE),

combination of proximal DVT, non fatal PE and death from all causes including PE

VTE related death,

Full Information

NCT ID

NCT00451412

First Posted

March 21, 2007

Last Updated

July 24, 2012

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00451412

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

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

Thromboembolism

Keywords

Venous thromboembolism, Medical patients, Heparin, Low molecular weight heparin, Deep vein thrombosis, Certoparin, Embolism and Thrombosis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3254 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Certoparin

Arm Type

Experimental

Arm Title

Unfractionated Heparin

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Certoparin

Other Intervention Name(s)

Sandoparin, Embolex, low molecular weight heparin

Intervention Description

3000 U anti XA of certoparin in 0.3 ml solution, once daily

Intervention Type

Drug

Intervention Name(s)

Unfractionated Heparin

Intervention Description

solution, 5000 IU of unfractionated heparin in 0.3 ml, 3 times daily

Primary Outcome Measure Information:

Title

Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism)

Time Frame

20 days

Secondary Outcome Measure Information:

Title

proximal and distal deep vein thrombosis (DVT) (combined and separate) assessed by ultrasound screening,

Time Frame

20 days

Title

symptomatic DVT,

Time Frame

20 days

Title

symptomatic non-fatal pulmonary embolism (PE),

Time Frame

20 days

Title

combination of proximal DVT, non fatal PE and death from all causes including PE

Time Frame

20 days

Title

VTE related death,

Time Frame

20 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Hospitalized medical patients 70 years of age or older Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances) written informed consent Exclusion Criteria: immobilization longer than 3 days prior to randomization prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system expected major surgical or invasive procedure within the next 3 weeks after randomization LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization immobilization due to cast or fracture indication for anticoagulatory or thrombolytic therapy acute symptomatic DVT / PE known hypersensitivity to any of the study drugs or drugs with similar chemical structures Acute or history of heparin induced thrombocytopenia type II (HIT II) Other protocol-defined inclusion/exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis

Organizational Affiliation

Novartis

Official's Role

Study Director

Facility Information:

Facility Name

Novartis investigative sites

City

Nürnberg

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

21791091

Citation

Haas S, Schellong SM, Tebbe U, Gerlach HE, Bauersachs R, Melzer N, Abletshauser C, Sieder C, Bramlage P, Riess H. Heparin based prophylaxis to prevent venous thromboembolic events and death in patients with cancer - a subgroup analysis of CERTIFY. BMC Cancer. 2011 Jul 26;11:316. doi: 10.1186/1471-2407-11-316.

Results Reference

derived

PubMed Identifier

21505722

Citation

Bauersachs R, Schellong SM, Haas S, Tebbe U, Gerlach HE, Abletshauser C, Sieder C, Melzer N, Bramlage P, Riess H. CERTIFY: prophylaxis of venous thromboembolism in patients with severe renal insufficiency. Thromb Haemost. 2011 Jun;105(6):981-8. doi: 10.1160/TH10-09-0614. Epub 2011 Apr 20.

Results Reference

derived

PubMed Identifier

21315215

Citation

Tebbe U, Schellong SM, Haas S, Gerlach HE, Abletshauser C, Sieder C, Bramlage P, Riess H. Certoparin versus unfractionated heparin to prevent venous thromboembolic events in patients hospitalized because of heart failure: a subgroup analysis of the randomized, controlled CERTIFY study. Am Heart J. 2011 Feb;161(2):322-8. doi: 10.1016/j.ahj.2010.10.005.

Results Reference

derived

Learn more about this trial

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

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