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

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04295486
• Other study ID #: 20190973
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2021
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: Ramakanth Yakkanti, MD
• Phone: 502-689-3127
• Email: ramakanth.yakkanti[@]jhsmiami.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5478
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

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

Locations

Country	Name	City	State
United States	University of Miami Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of symptomatic thromboembolic events	Efficacy of prophylaxis will be reported as the number of reported incidence of symptomatic Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT).	90 days
Secondary	Incidence of specific adverse events	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.	90 days