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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of symptomatic thromboembolic events

Secondary outcome measures

Incidence of specific adverse events

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

901 Previous Clinical Trials

404,508 Total Patients Enrolled

1 Trials studying Deep Vein Thrombosis

40 Patients Enrolled for Deep Vein Thrombosis

Victor Hernandez, MDPrincipal InvestigatorUniversity of Miami

Media Library

Aspirin (Antiplatelet agent) Clinical Trial Eligibility Overview. Trial Name: NCT04295486 — Phase 2

Deep Vein Thrombosis Research Study Groups: Treatment Once Daily, Treatment Twice Daily

Deep Vein Thrombosis Clinical Trial 2023: Aspirin Highlights & Side Effects. Trial Name: NCT04295486 — Phase 2

Aspirin (Antiplatelet agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04295486 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions are commonly treated with Aspirin?

"Percutaneous coronary intervention (PCI) is typically managed through Aspirin, though it can also aid in treating inflammation and other issues such as dental procedures or neck pain."

Answered by AI

What potential adverse effects can result from Aspirin consumption?

"Considering the Phase 2 status of aspirin, there is sufficient evidence to assign a score of two for its safety. However, no proof currently exists that this drug produces any efficacy."

Answered by AI

How many individuals are currently enrolled in this trial?

"Affirmative. The information posted on clinicaltrials.gov indicates that this research initiative is actively recruiting participants. Initially uploaded to the site in March 2021, the trial has since been updated and now seeks 5478 patients from a single medical center."

Answered by AI

Has any similar research been conducted prior to this clinical trial?

"Since the initial trial of Aspirin in 2005, sponsored by Abbott and involving 15480 patients, this drug has gone on to receive Phase 4 approval. Currently, 168 different clinical trials for aspirin are active across 57 countries and 1398 cities."

Answered by AI

Is this research endeavor presently open for recruitment?

"Actually, the clinicaltrials.gov page reveals that this medical trial is recruiting participants and was first listed on March 1st 2021. As of now, 5478 individuals are needed from a single site to complete the study with its last edit made on March 12th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Victor Hugo Hernandez 2021. "Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For VTE Following Total Joint Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04295486.

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