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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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.

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for: Apixaban Enoxaparin Sodium

U.S. FDA Resources

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
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 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 Other Name: BMS-562247
Active Comparator: Arm 2 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

Show 298 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

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

Investigator Inquiry form 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

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI; ADOPT Trial Investigators. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011 Dec 8;365(23):2167-77. Epub 2011 Nov 13.

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00457002 History of Changes
Other Study ID Numbers:	CV185-036
Study First Received:	April 4, 2007
Last Updated:	June 27, 2011
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

Additional relevant MeSH terms:

Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

Thromboembolism
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