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Anticoagulant
Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness (ADOPT Trial)
Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to last dose of study drug plus 2 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
No Placebo-Only Group
Pivotal Trial
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.
Eligible Conditions
- Pulmonary Embolism
- Deep Vein Thrombosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intended treatment period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intended treatment period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of All Bleeding During the Treatment Period in Treated Participants
Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
Therapeutic procedure
+2 moreSecondary study objectives
Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period
Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period
Incidence of Adjudicated PE With Onset During the Intended Treatment Period
+24 moreSide effects data
From 2018 Phase 4 trial • 557 Patients • NCT018843377%
Incision site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
TOTAL KNEE REPLACEMENT (TKR)
TOTAL HIP REPLACEMENT (THR)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1Experimental Treatment1 Intervention
While hospitalized, Apixaban plus Placebo
Apixaban (Tablets, Oral, 2.5 mg), Placebo (Syringes, SC)
After hospital discharge, Apixaban
Apixaban (Tablets, Oral, 2.5 mg)
Group II: Arm 2Active Control1 Intervention
While hospitalized, Enoxaparin plus Placebo
Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral)
After hospital discharge: Placebo
Placebo (Tablets, Oral)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apixaban
FDA approved
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,092,313 Total Patients Enrolled
12 Trials studying Pulmonary Embolism
32,773 Patients Enrolled for Pulmonary Embolism