NCT00451412

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,254

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

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

January 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 25, 2012

Status Verified

July 1, 2012

Enrollment Period

2.4 years

First QC Date

March 21, 2007

Last Update Submit

July 24, 2012

Conditions

Thromboembolism

Keywords

Venous thromboembolismMedical patientsHeparinLow molecular weight heparinDeep vein thrombosisCertoparinEmbolism and Thrombosis

Outcome Measures

Primary Outcomes (1)

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

    20 days

Secondary Outcomes (5)

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

    20 days

  • symptomatic DVT,

    20 days

  • symptomatic non-fatal pulmonary embolism (PE),

    20 days

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

    20 days

  • VTE related death,

    20 days

Study Arms (2)

Certoparin

EXPERIMENTAL
Drug: Certoparin

Unfractionated Heparin

ACTIVE COMPARATOR
Drug: Unfractionated Heparin

Interventions

CertoparinDRUG

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

Also known as: Sandoparin, Embolex, low molecular weight heparin
Certoparin
Unfractionated HeparinDRUG

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

Unfractionated Heparin

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis investigative sites

Nuremberg, Germany

Location

Related Publications (3)

  • 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.

    PMID: 21791091DERIVED

  • 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.

    PMID: 21505722DERIVED

  • 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.

    PMID: 21315215DERIVED

MeSH Terms

Conditions

ThromboembolismVenous ThromboembolismVenous ThrombosisEmbolism and Thrombosis

Interventions

certoparinSandoparinheparin-dihydergotHeparin, Low-Molecular-WeightHeparin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesThrombosis

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2007

First Posted

March 23, 2007

Study Start

January 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

July 25, 2012

Record last verified: 2012-07

Locations

DE(1)