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

NCT ID: NCT04295486

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

5478 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2026-03-01

Brief Summary

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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

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Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment Once Daily

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

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Non-enteric coated 81 mg Aspirin tablet.

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.

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Non-enteric coated 81 mg Aspirin tablet.

Interventions

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Aspirin

Non-enteric coated 81 mg Aspirin tablet.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Victor Hugo Hernandez

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victor Hernandez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami Hospital

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ramakanth Yakkanti, MD

Role: CONTACT

502-689-3127

Facility Contacts

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Ramakanth Yakkanti

Role: primary

502-689-3127

Other Identifiers

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20190973

Identifier Type: -

Identifier Source: org_study_id

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