Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For VTE Following Total Joint Arthroplasty

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT04295486
Phase
PHASE2
Status
Recruiting
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Conditions

  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aspirin — DRUG
    Non-enteric coated 81 mg Aspirin tablet.

Study Details

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.

Key Dates

Start date
Mar 1, 2021
Status verified
Mar 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
5,478 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Treatment Once Daily
    Participant receives 81 mg aspirin taken once daily beginning the night before surgery and up to 28 days post surgery.
  • Active Comparator: Treatment Twice Daily
    Participant 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.

Primary Outcome Measure

Incidence of symptomatic thromboembolic events [ Time Frame: 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami HospitalMiamiFlorida33136
Ramakanth Yakkanti
[email protected]
502-689-3127
Victor Hernandez, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami Hospital· Miami, FL

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