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NCT Number: NCT04295486

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

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.

Recruiting

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami Hospital

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Ramakanth Yakkanti

CONTACT

[email protected]

502-689-3127

Victor Hernandez, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

Non-enteric coated 81 mg Aspirin tablet.

Primary outcomes

  1. Incidence of symptomatic thromboembolic events

    Time frame: 90 days

    Efficacy of prophylaxis will be reported as the number of reported incidence of symptomatic Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT).

Secondary outcomes

  1. Incidence of specific adverse events

    Time frame: 90 days

    Efficacy of prophylaxis will be reported as the number of reported incidence of specific adverse events including gastrointestinal (GI) complications, post-operative hematoma, bleeding and wound complications and infections.

Study contacts

Contact information is provided by the study sponsor or research team.

Ramakanth Yakkanti, MD

CONTACT

[email protected]

502-689-3127

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2020
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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