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Antiplatelet agent

Low-Dose Aspirin Dosing for Blood Clot Prevention After Surgery

Phase 2

Recruiting

Led By Victor Hernandez, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age

Planning to undergo a primary total hip or knee arthroplasty

Must not have

Patients requiring anticoagulation for pre-existing conditions

BMI > 40

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if taking a lower dose of aspirin once a day is as effective as taking a higher dose of aspirin twice a day in preventing blood clots after surgery.

Who is the study for?

This trial is for adults over 18 who are about to have hip or knee replacement surgery and can understand the consent form. It's not for those with a history of blood clots, cancer, mental illness, extreme obesity (BMI > 40), pregnancy, or conditions that make aspirin use unsafe.

What is being tested?

The study is testing if taking low-dose aspirin once a day is just as good at preventing blood clots after joint replacement surgery as taking it twice a day. Participants will receive either one or two doses daily.

What are the potential side effects?

Aspirin may cause side effects like stomach upset or bleeding. Rarely, some people might experience allergic reactions or more serious issues such as ulcers if they're sensitive to aspirin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for a first-time hip or knee replacement surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need blood thinners for a condition I already have.

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My BMI is over 40.

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I have had blood clots in my veins before.

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I currently have cancer.

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I have a condition that increases my risk of blood clots.

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I cannot take aspirin or NSAIDs due to conditions like stomach ulcers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of symptomatic thromboembolic events

Secondary study objectives

Incidence of specific adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Once DailyExperimental Treatment1 Intervention

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

Group II: Treatment Twice DailyActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aspirin

2014

Completed Phase 4

~55580

0 / 8Eligibility criteria met