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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Pulmonary Embolism; Venous Thrombosis

Treatments: Drug: Apixaban; Drug: Enoxaparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00457002

CV185-036

Details and patient eligibility

About

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.

Enrollment: 6,758 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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 venous thromboembolism (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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6,758 participants in 2 patient groups

Arm 1

Experimental group

Description:

While hospitalized, Apixaban plus Placebo Apixaban (Tablets, Oral, 2.5 mg), Placebo (Syringes, SC) After hospital discharge, Apixaban Apixaban (Tablets, Oral, 2.5 mg)

Treatment:

Drug: Apixaban

Arm 2

Active Comparator group

Description:

While hospitalized, Enoxaparin plus Placebo Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral) After hospital discharge: Placebo Placebo (Tablets, Oral)

Treatment:

Drug: Enoxaparin