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Antiplatelet Agent

A Different Approach to Preventing Thrombosis (ADAPT Trial)

Phase 3
Waitlist Available
Led By Deborah Stein, MD, MPH
Research Sponsored by University of Maryland, Baltimore
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 90 days
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

The purpose of this study is to perform a pragmatic randomized controlled trial to compare the use of low molecular weight heparin (LMWH, lovenox, enoxaparin) versus acetylsalicylic acid (ASA) for venous thromboembolism (VTE) prophylaxis in patients with high-risk lower extremity fractures.

Eligible Conditions
  • Venous Thromboembolism
  • Pulmonary Embolism
  • Deep Vein Thrombosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Treatment-related Bleeding Events as Assessed by the Need for Blood Transfusions and Procedures for Bleeding Complications After Initiation of the Study Medication.
Secondary study objectives
Number of Participants With Deep Venous Thromboembolism
Number of Participants With Pulmonary Embolism Events

Awards & Highlights

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
Active Control
Group I: VTE prophylaxis with Enoxaparin 30mg BIDActive Control1 Intervention
The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.
Group II: VTE prophylaxis with Aspirin 81mg BIDActive Control1 Intervention
The group receiving VTE prophylaxis with ASA 81mg PO BID

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,020 Total Patients Enrolled
Deborah Stein, MD, MPHPrincipal InvestigatorR. Adams Cowley Shock Trauma Center
2 Previous Clinical Trials
94 Total Patients Enrolled
~33 spots leftby Dec 2025
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