Study of Apixaban for the Prevention of Thrombosis-Related Events in Patients With Acute Medical Illness - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00457002

Purpose

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

Condition	Intervention	Phase
Venous Thrombosis Pulmonary Embolism	Drug: Apixaban Drug: Enoxaparin	Phase III

MedlinePlus related topics: Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for: Apixaban Enoxaparin Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase 3 Randomized, Double-Blind, Parallel-Group, Multi-Center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Composite of venous thromboembolism (VTE) and VTE-related death [ Time Frame: during 30 days of double-blind treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary outcomes include all cause death, major bleeding, and clinically relevant non-major bleeding [ Time Frame: during 30 days of double-blind treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	6524
Study Start Date:	June 2007
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental While hospitalized, Apixaban plus Placebo Apixaban (Tablets, Oral, 2.5 mg), Placebo (Syringes, SC) After hospital discharge, Apixaban Apixaban (Tablets, Oral, 2.5 mg)	Drug: Apixaban Apixaban: Twice daily, 30 days Placebo: Once daily, 6-14 days
Arm 2: Active Comparator While hospitalized, Enoxaparin plus Placebo Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral) After hospital discharge: Placebo Placebo (Tablets, Oral)	Drug: Enoxaparin Enoxaparin: Once daily, 6-14 days Placebo: Twice daily, 30 days

Eligibility

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

Criteria

Inclusion Criteria:

men and non-pregnant, non-breastfeeding women
40 years or older
hospitalized with congestive heart failure or acute respiratory failure
infection (without septic shock)
acute rheumatic disorder
inflammatory bowel disease

Exclusion Criteria:

patients with VTE
active bleeding or at high risk of bleeding
unable to take oral medication
with diseases requiring ongoing treatment with anticoagulants or antiplatelets other than aspirin at a dose ≤ 165 mg/day.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457002

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 331 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CV185-036
Study First Received:	April 4, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00457002
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Prevention of deep vein thrombosis and pulmonary embolism with acutely ill hospitalized patients

Study placed in the following topic categories:

Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism
Lung Diseases
Vascular Diseases

Venous Thrombosis
Venous Thromboembolism
Thromboembolism
Thrombosis
Enoxaparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009