Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00714597

Purpose

The primary objective of the study is to compare the efficacy of AVE5026 with Enoxaparin for the primary prevention of Venous Thromboembolic Events (VTE) in patients hospitalized for acute medical illness.

The secondary objectives of this study are to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.

Condition	Intervention	Phase
Venous Thromboembolism	Drug: Semuloparin sodium (AVE5026) Drug: Enoxaparin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Primary Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis

Drug Information available for: Enoxaparin Sodium

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Occurence of the composite endpoint of asymptomatic proximal Deep Vein Thrombosis (DVT), symptomatic VTE and VTE-related deaths as confirmed by a blinded Central Independent Adjudication Committee (CIAC) [ Time Frame: From randomization up Day 15 or the day of the mandatory Compression Ultrasound (CUS), whichever comes first. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurence of each component of the primary efficacy endpoint: asymptomatic proximal DVT, symptomatic VTE and VTE-related deaths [ Time Frame: From randomization up Day 15 or the day of the mandatory CUS, whichever comes first. ] [ Designated as safety issue: No ]
Number of patients with major bleedings and clinically relevant non-major bleedings as confirmed by the CIAC [ Time Frame: Up to a maximum of 42 days ] [ Designated as safety issue: Yes ]
Number of patients requiring the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment [ Time Frame: Up to a maximum of 42 days ] [ Designated as safety issue: No ]

Enrollment:	421
Study Start Date:	July 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AVE5026 AVE5026, once daily. The dose was reduced in patients with severe renal impairment.	Drug: Semuloparin sodium (AVE5026) Form: solution in ready-to-use prefilled syringe Route: subcutaneous injection
Active Comparator: Enoxaparin Enoxaparin, 40 mg once daily. The dose was reduced to 20 mg in patients with severe renal impairment.	Drug: Enoxaparin Form: solution in ready-to-use prefilled syringe Route: subcutaneous injection

Detailed Description:

The total duration of observation per patient is 35 - 42 days from randomization, and includes:

a treatment period of 10 - 14 days,
a follow-up period of 25 - 32 days.

Mandatory compression ultrasound (CUS) is performed 10 to 15 days after randomization.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient with an acute medical condition requiring bed rest for at least 3 days, and hospitalized for at least one of the following medical conditions:
- Congestive heart failure (New York Heart Association [NYHA] class III/IV),
- Acute respiratory failure (not requiring mechanical ventilation),
- Acute infection (without septic shock)*,
- Acute rheumatic disorder*,
- Acute episode of inflammatory bowel disease*.
  
  *Patients with these conditions should have at least one additional risk factor for venous thromboembolism (VTE) among the following:
- Age ≥ 75 years,
- Active cancer or myeloproliferative disorders (having received treatment for cancer within the last 6 months),
- Previous VTE,
- Obesity,
- Oral hormone therapy (antiandrogen or estrogen),
- Chronic heart failure,
- Chronic respiratory failure.

Exclusion Criteria:

Previous surgery with general anesthesia within 30 days before inclusion in the study,
Patient requiring a curative anticoagulant or thrombolytic treatment,
Patient at risk of bleeding,
Stroke,
Known hypersensitivity to heparin or enoxaparin sodium.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714597

Show 21 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:	Patrick Mismetti, MD	University Hospital of Saint-Etienne, France
Study Chair:	Alexander Turpie, MD	HHS-General Hospital, Hamilton, Canada

More Information

No publications provided

Responsible Party:	International Clinical Development Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00714597 History of Changes
Other Study ID Numbers:	EFC10572, 2008-000228-13
Study First Received:	July 9, 2008
Last Updated:	July 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Venous thrombosis
Primary prevention

Additional relevant MeSH terms:

Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Enoxaparin
Anticoagulants

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012