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Anticoagulant

Arm 1 for Pulmonary Embolism (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 intended treatment period
Awards & highlights

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 weeks
Treatment ~ Varies
Follow Up ~intended treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and intended treatment period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
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 more

Side effects data

From 2018 Phase 4 trial • 557 Patients • NCT01884337
7%
Incision site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
TOTAL KNEE REPLACEMENT (TKR)
TOTAL HIP REPLACEMENT (THR)

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
2,652 Previous Clinical Trials
4,123,991 Total Patients Enrolled
12 Trials studying Pulmonary Embolism
32,773 Patients Enrolled for Pulmonary Embolism
~372 spots leftby Aug 2025
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