Efficacy of Aspirin in Preventing Venous Thromboembolism

NCT06635317 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 151.2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy of aspirin and enoxaparin in preventing venous tromboembolism was compared after total knee or hip arthroplasty.

Conditions

Venous Thromboembolism (VTE); Total Joint Arthroplasty; Total Hip Arthroplasty (THA)

Keywords

Aspirin; Venous thromboembolism; Total knee replacement; Total hip replacement; Thromboprophylaxis

Outcome Measures

Primary Outcomes (1)

• Symptomatic VTE

  90 days

Secondary Outcomes (1)

• Wound bleeding

  90 days

Study Arms (2)

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

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.

Drug: enoxaparin

Interventions

Aspirin DRUG

100 mg/day orally for 25 days

Long term aspirin group

enoxaparin DRUG

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.

Enoxaparin group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients provided written informed consent.
• All patients who underwent primary total hip or total knee arthroplasty for osteoarthritis

You may not qualify if:

• 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).

Sponsors & Collaborators

• Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado: lead

Study Sites (1)

ISSSTEP

Puebla City, 72450, Mexico

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Aspirin; Enoxaparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 10, 2024
• Study Start: April 24, 2022
• Primary Completion: October 24, 2022
• Study Completion: February 28, 2023
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)