Recruiting
Phase 2

Aspirin

Sponsor:

University of Miami

Code:

NCT04295486

Conditions

Venous Thromboembolism

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Aspirin

Study Details

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.

Conditions

Venous Thromboembolism

Study ID

NCT04295486

Start date

Mar 1, 2021

Status verified date

Mar, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5478 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Aspirin

Non-enteric coated 81 mg Aspirin tablet.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ramakanth Yakkanti, MD

502-689-3127ramakanth.yakkanti@jhsmiami.org

Locations

University of Miami Hospital

Recruiting

Miami, Florida, United States, 33136

Contacts

Ramakanth Yakkanti

502-689-3127ramakanth.yakkanti1@jhsmiami.org

Principal Investigator:

Victor Hernandez, MD

More Information

Sponsor

University of Miami

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • Chemoprophylaxis
  • Hip Surgery
  • Knee Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-03-11.