NCT00311753

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

April 4, 2006

Last Update Submit

February 22, 2017

Conditions

Embolism

Keywords

heparin, thromboprophylaxis, medical patients, acutely illAcutely ill non surgical patientsImmobilization

Outcome Measures

Primary Outcomes (1)

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

    10 ± 2 days

Secondary Outcomes (2)

  • Thromboembolic events during follow-up period of 3 months

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

  • 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

Study Arms (2)

1

EXPERIMENTAL

Certoparin

Drug: Certoparin

2

ACTIVE COMPARATOR

Heparin

Drug: Heparin

Interventions

CertoparinDRUG

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

1
HeparinDRUG

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

2

Eligibility Criteria

Age40 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalization due to an acute non-surgical disease
  • Significant decrease in mobility

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Investigative Centers, Germany

Location

Novartis Pharmaceuticals

Basel, Switzerland

Location

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

    PMID: 20950224RESULT

MeSH Terms

Conditions

Embolism

Interventions

certoparinHeparin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 4, 2006

First Posted

April 6, 2006

Study Start

February 1, 2006

Primary Completion

December 1, 2007

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

CH(1)DE(1)