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

University of Miami

Status and phase: Enrolling; Phase 2

Conditions: Venous Thromboembolism

Treatments: Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT04295486

20190973

Details and patient eligibility

About

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.

Enrollment: 5,478 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,478 participants in 2 patient groups

Treatment Once Daily

Experimental group

Description:

Participant receives 81 mg aspirin taken once daily beginning the night before surgery and up to 28 days post surgery.

Treatment:

Drug: Aspirin

Treatment Twice Daily

Active Comparator group

Description:

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.

Treatment:

Drug: Aspirin