Study to Evaluate the Mortality Reduction of Enoxaparin in Hospitalized Acutely Ill Medical Receiving Enoxaparin

NCT00622648 | Completed Phase 4

• 1 other identifier: ENOXA_C_01249
• Study Type: interventional
• Target: 8,329
• Locations: 9 countries
• Sites: 9

Brief Summary

The primary objective:

• To demonstrate in patients hospitalized for an acute medical illness that enoxaparin with Graduated Elastic Stockings is superior to enoxaparin-placebo with Graduated Elastic Stockings on overall mortality at day 30 after randomization. The secondary objective:
• To compare, in patients hospitalized for an acute medical illness, enoxaparin with Graduated Elastic Stockings versus enoxaparin placebo with Graduated Elastic Stockings on overall mortality at day 90 after randomization.
• To evaluate the safety of enoxaparin VTE prophylaxis in patients hospitalized for acute medical illness with respect to major hemorrhage, total bleedings, heparin induced thrombocytopenia, adverse events and serious adverse events .

Conditions

Acute Illness

Keywords

Medical prevention therapy

Outcome Measures

Primary Outcomes (2)

• Death rate with all causes mortality

  At day 30

• Hemorrhages

  Occuring until day 90

Secondary Outcomes (2)

• All-cause mortality

  Between randomization and day 90

• Adverse events, serious adverse events

  During the entire observation period (from informed consent signature until Day 90)

Study Arms (2)

A

EXPERIMENTAL

Enoxaparin: 40 mg once daily for 6 to 14 days (10 ± 4 days)

Drug: Enoxaparin

B

PLACEBO COMPARATOR

Enoxaparin placebo 40mg once daily for 6 to 14 days (10 ± 4 days)

Drug: Placebo

Interventions

Enoxaparin DRUG

40 mg once daily for 6 to 14 days (10 ± 4 days)

A

Placebo DRUG

Enoxaparin placebo 40mg once daily for 6 to 14 days (10 ± 4 days)

B

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Hospitalization within 48 hours prior randomization for at least one of the following medical acute medical illness:
• Acute decompensation of heart failure
• Severe systemic infection and at least one of the following:
• Chronic pulmonary diseases (COPD, pulmonary fibrosis, pulmonary restrictive syndrome…)
• Obesity (BMI ≥ 30kg/m2)
• Personal history of VTE
• Age ≥ 60 years
• Active cancer (defined as being histologically confirmed with an initial diagnosis or recurrence or metastasis within the past 6 months) excluding planned hospitalization for chemotherapy
• Anticipated duration of hospitalization at least 6 days
• Health status:
• ASA Health status score ≤ 3 (American Society of Anesthesiologists)
• ECOG ≤ 2 in cancer patient
• Anticipated life expectancy \> 1 week
• Major surgery or major trauma within the previous 6 weeks (orthopedic or trauma surgery to the lower extremities, gastrointestinal tract, urological, chest, gynecological surgery)
• Need for any ventilatory support (with intubation required)

Sponsors & Collaborators

• Sanofi: lead

Study Sites (9)

Sanofi-Aventis Administrative Office

São Paulo, Brazil

Location

Sanofi-Aventis Administrative Office

Shanghai, China

Location

Sanofi-Aventis Administrative Office

Hong Kong, Hong Kong

Location

Sanofi-Aventis Administrative Office

Mumbai, India

Location

Sanofi-Aventis Administrative Office

Kuala Lumpur, Malaysia

Location

Sanofi-Aventis Administrative Office

Col. Coyoacan, Mexico

Location

Sanofi-Aventis Administrative Office

Makati City, Philippines

Location

Sanofi-Aventis Administrative Office

Seoul, South Korea

Location

Sanofi-Aventis Administrative Office

Mégrine, Tunisia

Location

Related Publications (1)

• Kakkar AK, Cimminiello C, Goldhaber SZ, Parakh R, Wang C, Bergmann JF; LIFENOX Investigators. Low-molecular-weight heparin and mortality in acutely ill medical patients. N Engl J Med. 2011 Dec 29;365(26):2463-72. doi: 10.1056/NEJMoa1111288.

  PMID: 22204723 DERIVED

MeSH Terms

Interventions

Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Bruno DESLANDES

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 25, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 28, 2010

Record last verified: 2010-12

Locations

IN (1); HK (1); TU (1); KR (1); MY (1); CN (1); BR (1); ME (1); PH (1)