Venous Thromboembolism (VTE)Phase 4NCT06635317
Efficacy of Aspirin in Preventing Venous Thromboembolism
A Phase 4 study testing Aspirin and enoxaparin in people with Venous Thromboembolism (VTE) and Total Joint Arthroplasty, run by Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado at 1 site in Mexico.
Trial summary
Efficacy of aspirin and enoxaparin in preventing venous tromboembolism was compared after total knee or hip arthroplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Thromboembolism (VTE), Total Joint Arthroplasty, Total Hip Arthroplasty (THA)
- What is being tested?
- Aspirin and enoxaparin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 24 Apr 2022to 28 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients provided written informed consent.
- All patients who underwent primary total hip or total knee arthroplasty for osteoarthritis
Who cannot join
- preoperative anticoagulation (direct oral anticoagulant, warfarin, IMPROVE Bleeding Score more or equal to 7, dual antiplatelet therapy)
- medical contraindications (allergy, cancer, cardiac disease, kidney disease, or bleeding disorder precluding anticoagulation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Arpirin in Preventing Venous Thromboembolism in Total Knee and Hip Replacement
Efficacy of aspirin and enoxaparin in preventing venous tromboembolism was compared after total knee or hip arthroplasty.
Read the detailed description
Background: Venous thromboembolism (VTE) remains a significant risk following joint replacements, despite advancements in prevention strategies. Aspirin-based therapies have gained popularity due to their perceived safety, ease of administration, and supportive evidence.This study aimed to compare the efficacy of aspirin and enoxaparin in preventing VTE after total knee or hip arthroplasty.
Methods: Sixty patients undergoing primary total knee or hip arthroplasty were randomized to receive either aspirin or enoxaparin. The primary outcome was symptomatic VTE within 90 days. Patients were followed up for Doppler ultrasound evaluations.
- Being tested
- Aspirin, enoxaparin
- Keywords
- Aspirin, Venous thromboembolism, Total knee replacement, Total hip replacement, Thromboprophylaxis
- 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
100 mg/day orally for 25 days
enoxaparinDrug
40 mg/day subcutaneously for 28 days, with the dose reduced to 20 mg for patients weighing less than 50 kg or with an estimated glomerular filtration rate less than 30 mL/min/1.73 m².
| Study group | Role | What they receive |
|---|---|---|
| Long term aspirin group | Active comparator | Long term aspirin group received enoxaparin, 40 mg/day subcutaneously for 3 days, and aspirin, 100 mg/day orally for 25 days Receives: Drug: Aspirin |
| Enoxaparin group | Active comparator | enoxaparin group received enoxaparin, 40 mg/day subcutaneously for 28 days, with the dose reduced to 20 mg for patients weighing less than 50 kg or with an estimated glomerular filtration rate less than 30 mL/min/1.73 m². Receives: Drug: enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic VTE
Measured: 90 days
Secondary outcomes (1)
Wound bleeding
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 posted10 Oct 2024
- Study start24 Apr 2022
- Primary completion24 Oct 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolism (VTE)Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- All patients who underwent a preoperative Doppler ultrasound of the lower extremities to screen for VTE and received antibiotic prophylaxis with cephalothin 1 gram intravenously. At six hours post-surgery, patients in the aspirin group received enoxaparin, 40 mg/day subcutaneously for 3 days, and aspirin, 100 mg/day orally for 25 days. Patients in the enoxaparin group received enoxaparin, 40 mg/day subcutaneously for 28 days, with the dose reduced to 20 mg for patients weighing less than 50 kg or with an estimated glomerular filtration rate less than 30 mL/min/1.73 m². Additionally, all patients received pneumatic compression stockings postoperatively for at least 21 days as standard care. Physical therapy was initiated on the day of surgery or postoperative day 1 and continued daily throughout the hospital stay. Postoperative wound care and Doppler ultrasound evaluations were performed at two and four weeks postoperatively to detect any evidence of VTE.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ana Luisa Galicia Zamalloa, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635317
- Sponsor's protocol ID
- 151.2022
- Other IDs
- 151.2022
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Arpirin in Preventing Venous Thromboembolism in Total Knee and Hip Replacement
- ClinicalTrials.gov ID
- NCT06635317
- Acronym / sponsor ID
- 151.2022
- Keywords
- Aspirin, Venous thromboembolism, Total knee replacement, Total hip replacement, Thromboprophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del EstadoOther government
- Study start
- 24 Apr 2022 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 10 Oct 2024 (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.
Efficacy of aspirin and enoxaparin in preventing venous tromboembolism was compared after total knee or hip arthroplasty.
Detailed description
Background: Venous thromboembolism (VTE) remains a significant risk following joint replacements, despite advancements in prevention strategies. Aspirin-based therapies have gained popularity due to their perceived safety, ease of administration, and supportive evidence.This study aimed to compare the efficacy of aspirin and enoxaparin in preventing VTE after total knee or hip arthroplasty.
Methods: Sixty patients undergoing primary total knee or hip arthroplasty were randomized to receive either aspirin or enoxaparin. The primary outcome was symptomatic VTE within 90 days. Patients were followed up for Doppler ultrasound evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All patients who underwent a preoperative Doppler ultrasound of the lower extremities to screen for VTE and received antibiotic prophylaxis with cephalothin 1 gram intravenously. At six hours post-surgery, patients in the aspirin group received enoxaparin, 40 mg/day subcutaneously for 3 days, and aspirin, 100 mg/day orally for 25 days. Patients in the enoxaparin group received enoxaparin, 40 mg/day subcutaneously for 28 days, with the dose reduced to 20 mg for patients weighing less than 50 kg or with an estimated glomerular filtration rate less than 30 mL/min/1.73 m². Additionally, all patients received pneumatic compression stockings postoperatively for at least 21 days as standard care. Physical therapy was initiated on the day of surgery or postoperative day 1 and continued daily throughout the hospital stay. Postoperative wound care and Doppler ultrasound evaluations were performed at two and four weeks postoperatively to detect any evidence of VTE.
| Arm | Type | Receives |
|---|---|---|
| Long term aspirin group | Active comparator | Drug: AspirinLong term aspirin group received enoxaparin, 40 mg/day subcutaneously for 3 days, and aspirin, 100 mg/day orally for 25 days |
| Enoxaparin group | Active comparator | Drug: enoxaparinenoxaparin group received enoxaparin, 40 mg/day subcutaneously for 28 days, with the dose reduced to 20 mg for patients weighing less than 50 kg or with an estimated glomerular filtration rate less than 30 mL/min/1.73 m². |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients provided written informed consent.
- All patients who underwent primary total hip or total knee arthroplasty for osteoarthritis
Key exclusion criteria (2 listed)
- preoperative anticoagulation (direct oral anticoagulant, warfarin, IMPROVE Bleeding Score more or equal to 7, dual antiplatelet therapy)
- medical contraindications (allergy, cancer, cardiac disease, kidney disease, or bleeding disorder precluding anticoagulation).
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 |
|---|---|---|
| Aspirin100 mg/day orally for 25 days | Drug | Long term aspirin group |
| enoxaparin40 mg/day subcutaneously for 28 days, with the dose reduced to 20 mg for patients weighing less than 50 kg or with an estimated glomerular filtration rate less than 30 mL/min/1.73 m². | Drug | Enoxaparin group |
Primary outcome
Symptomatic VTE
Time frame: 90 days
1 secondary outcome
Wound bleeding
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and enoxaparin in people with Venous Thromboembolism (VTE) and Total Joint Arthroplasty, run by Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado at 1 site in Mexico.
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 2 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: finished, as of the sponsor's last update on 10 Oct 2024. 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 Mexico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic VTE (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 10 Oct 2024.