Clinical trial

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

Name

20190973

Description

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.

Trial arms

Trial start

2021-03-01

Estimated PCD

2025-03-01

Trial end

2025-03-01

Status

Recruiting

Phase

Early phase I

Treatment

Aspirin

Non-enteric coated 81 mg Aspirin tablet.

Arms:

Treatment Once Daily, Treatment Twice Daily

Size

5478

Primary endpoint

Incidence of symptomatic thromboembolic events

90 days

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5478, 'type': 'ESTIMATED'}}

Updated at

2024-03-01

1 organization

1 drug

1 indication

Organization

University of Miami

Drug

Aspirin

Indication

Venous Thromboembolism