Menu
Recruiting NCT04295486

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

Phase II Interventional Venous Thromboembolism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aspirin.
Who it may be relevant to
Registry conditions: Venous Thromboembolism. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For Venous Thromboembolism (VTE) Following Total Joint Arthroplasty - A Multi-center Prospective Randomized Control Trial.

Overview

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.

Interventions

  • Drug Aspirin
    Non-enteric coated 81 mg Aspirin tablet.

Primary outcome measures

  • Incidence of symptomatic thromboembolic events [Time frame: 90 days]
Secondary outcome measures (1)
  • Incidence of specific adverse events [Time frame: 90 days]

Eligibility criteria

Inclusion criteria

  • > 18 years of age
  • Planning to undergo a primary total hip or knee arthroplasty

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Miami Hospital — Miami

Identifiers

NCT: NCT04295486 · 20190973

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗