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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ intended treatment period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intended treatment period
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 moreSecondary 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 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)
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
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