NCT04295486 Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For VTE Following Total Joint Arthroplasty
| NCT ID | NCT04295486 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Miami |
| Condition | Venous Thromboembolism |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,478 participants |
| Start Date | 2021-03-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 5,478 participants in total. It began in 2021-03-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Victor Hernandez, MD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT04295486 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Venous Thromboembolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04295486 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04295486 currently recruiting?
Yes, NCT04295486 is actively recruiting participants. Contact the research team at ramakanth.yakkanti@jhsmiami.org for enrollment information.
Where is the NCT04295486 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT04295486 clinical trial?
NCT04295486 is sponsored by University of Miami. The principal investigator is Victor Hernandez, MD at University of Miami. The trial plans to enroll 5,478 participants.