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

Phase 2

Recruiting

• Conditions: Venous Thromboembolism
• Interventions: Drug: Aspirin

• Registration Number: NCT04295486
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-04
• Study Start: 2021-03-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5478

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Once Daily	Aspirin	Participant receives 81 mg aspirin taken once daily beginning the night before surgery and up to 28 days post surgery.
Treatment Twice Daily	Aspirin	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 Measures

Name	Time	Method
Incidence of symptomatic thromboembolic events	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 Outcome Measures

Name	Time	Method
Incidence of specific adverse events	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.

Trial Locations

Locations (1)

University of Miami Hospital; 🇺🇸 Miami, Florida, United States