Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness (ADOPT)


Tracking Information

Start Date  ICMJEJune 2007
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2008)		Composite of venous thromboembolism (VTE) and VTE-related death [ Time Frame: during 30 days of double-blind treatment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE 
 (submitted: April 4, 2007)		Composite of venous thromboembolism (VTE) and VTE-related death during 30 days of double-blind treatment.
Change HistoryComplete list of historical versions of study NCT00457002 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: August 13, 2008)		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 ]
Original Secondary Outcome Measures ICMJE 
 (submitted: April 4, 2007)		Secondary outcomes include all cause death, major bleeding, and clinically relevant non-major bleeding during 30 days of double-blind treatment.

Descriptive Information

Brief Title  ICMJEStudy of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness
Official Title  ICMJEA 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.
Brief Summary

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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJEPrevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Condition  ICMJE
  • Venous Thrombosis
  • Pulmonary Embolism
Intervention  ICMJE
  • Drug: Apixaban

    Apixaban: Twice daily, 30 days

    Placebo: Once daily, 6-14 days

    Other Name: BMS-562247
  • Drug: Enoxaparin

    Enoxaparin: Once daily, 6-14 days

    Placebo: Twice daily, 30 days

Study Arms / Comparison Groups
  • 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)

    Intervention: Drug: Apixaban
  • Arm 2: Active Comparator

    While hospitalized, Enoxaparin plus Placebo

    Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral)

    After hospital discharge: Placebo

    Placebo (Tablets, Oral)

    Intervention: Drug: Enoxaparin

Recruitment Information

Estimated Enrollment  ICMJE6524
Estimated Completion DateDecember 2010
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages40 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
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.
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   Czech Republic,   Denmark,   France,   Germany,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Norway,   Peru,   Philippines,   Poland,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00457002
Responsible PartyStudy Director, Bristol-Myers Squibb
Study ID Numbers  ICMJECV185-036
Study Sponsor  ICMJEBristol-Myers Squibb
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
Information Provided ByBristol-Myers Squibb