Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For VTE Following Total Joint Arthroplasty
1 other identifier
interventional
5,478
1 country
1
Brief Summary
This research study is attempting to answer the question of whether 81 mg aspirin once daily is as effective as 81 mg aspirin twice daily in preventing blood clots after total joint replacement surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2021
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2020
CompletedFirst Posted
Study publicly available on registry
March 4, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
March 11, 2026
March 1, 2026
6 years
March 2, 2020
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of symptomatic thromboembolic events
Efficacy of prophylaxis will be reported as the number of reported incidence of symptomatic Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT).
90 days
Secondary Outcomes (1)
Incidence of specific adverse events
90 days
Study Arms (2)
Treatment Once Daily
EXPERIMENTALParticipant receives 81 mg aspirin taken once daily beginning the night before surgery and up to 28 days post surgery.
Treatment Twice Daily
ACTIVE COMPARATORParticipant receives 81 mg aspirin taken twice daily (one in the morning and one at night) beginning at the night before surgery and up to 28 days post surgery.
Interventions
Eligibility Criteria
You may qualify if:
- \> 18 years of age
- Planning to undergo a primary total hip or knee arthroplasty
You may not qualify if:
- High risk patients for VTE as defined by:
- History of venous thromboembolism
- Active malignancy
- Known pro thrombotic condition
- BMI \> 40
- Patients requiring anticoagulation for pre-existing conditions
- Patients with the contraindication for use of aspirin or nonsteroidal antiinflammatory drugs for reasons such as peptic ulcer disease, intolerance, others.
- Patients not fluent in the language of the informed consent form
- Prisoners
- Pregnancy
- Reported to have mental illness or belonging to a vulnerable population
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami Hospital
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victor Hernandez, MD
University of Miami
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 2, 2020
First Posted
March 4, 2020
Study Start
March 1, 2021
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share