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

Sponsor

University of Miami (Other)

Overall Status

Recruiting

CT.gov ID

NCT04295486

Collaborator

(none)

5,478

Enrollment

Location

Arms

Anticipated Duration (Months)

210.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism	Drug: Aspirin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5478 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Once Daily Participant receives 81 mg aspirin taken once daily beginning the night before surgery and up to 28 days post surgery.	Drug: Aspirin Non-enteric coated 81 mg Aspirin tablet.
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.	Drug: Aspirin Non-enteric coated 81 mg Aspirin tablet.

Arm

Intervention/Treatment

Experimental: Treatment Once Daily

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

Drug: Aspirin

Non-enteric coated 81 mg Aspirin tablet.

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.

Drug: Aspirin

Non-enteric coated 81 mg Aspirin tablet.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Hospital	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator: Victor Hernandez, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Victor Hugo Hernandez, Associate Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT04295486

Other Study ID Numbers:

20190973

First Posted:

Mar 4, 2020

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Victor Hugo Hernandez, Associate Professor, University of Miami

Chemoprophylaxis

Hip Surgery

Knee Surgery

Additional relevant MeSH terms:

Thromboembolism

Venous Thromboembolism

Aspirin

Study Results

No Results Posted as of Mar 29, 2022