Venous ThromboembolismPhase 2NCT04295486
Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For VTE Following Total Joint Arthroplasty
A Phase 2 study testing Aspirin in people with Venous Thromboembolism, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,478 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 1 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years of age
- Planning to undergo a primary total hip or knee arthroplasty
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami Hospital
Miami, Florida, 33136
Ramakanth Yakkanti, 502-689-3127, ramakanth.yakkanti1@jhsmiami.org
Victor Hernandez, MD
About this study
Official title: Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For Venous Thromboembolism (VTE) Following Total Joint Arthroplasty - A Multi-center Prospective Randomized Control Trial.
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.
- Conditions
- Venous Thromboembolism
- Being tested
- Aspirin
- Keywords
- Chemoprophylaxis, Hip Surgery, Knee Surgery
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Non-enteric coated 81 mg Aspirin tablet.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Once Daily | Experimental | Participant receives 81 mg aspirin taken once daily beginning the night before surgery and up to 28 days post surgery. Receives: Drug: Aspirin |
| Treatment Twice Daily | Active comparator | 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. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic thromboembolic events
Efficacy of prophylaxis will be reported as the number of reported incidence of symptomatic Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT).
Measured: 90 days
Secondary outcomes (1)
Incidence of specific adverse events
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Mar 2021
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,478 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Hugo Hernandez, University of Miami
- Investigators
- Victor Hernandez, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295486
- Sponsor's protocol ID
- 20190973
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2020
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For Venous Thromboembolism (VTE) Following Total Joint Arthroplasty - A Multi-center Prospective Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04295486
- Acronym / sponsor ID
- 20190973
- Conditions
- Venous Thromboembolism
- Keywords
- Chemoprophylaxis, Hip Surgery, Knee Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,478 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Once Daily | Experimental | Drug: AspirinParticipant receives 81 mg aspirin taken once daily beginning the night before surgery and up to 28 days post surgery. |
| Treatment Twice Daily | Active comparator | Drug: AspirinParticipant 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- > 18 years of age
- Planning to undergo a primary total hip or knee arthroplasty
Key exclusion criteria (11 listed)
- High risk patients for VTE as defined by:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinNon-enteric coated 81 mg Aspirin tablet. | Drug | Treatment Once Daily, Treatment Twice Daily |
Primary outcome
Incidence of symptomatic thromboembolic events
Time frame: 90 days
Efficacy of prophylaxis will be reported as the number of reported incidence of symptomatic Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT).
1 secondary outcome
Incidence of specific adverse events
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victor Hernandez, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin in people with Venous Thromboembolism, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ramakanth Yakkanti, MD (502-689-3127, ramakanth.yakkanti@jhsmiami.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic thromboembolic events (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.