Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For VTE Following Total Joint Arthroplasty
Primary Purpose
Venous Thromboembolism
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aspirin
Sponsored by
About this trial
This is an interventional prevention trial for Venous Thromboembolism focused on measuring Chemoprophylaxis, Hip Surgery, Knee 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
Sites / Locations
- University of Miami HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment Once Daily
Treatment Twice Daily
Arm Description
Participant receives 81 mg aspirin taken once daily beginning the night before surgery and up to 28 days post surgery.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04295486
Brief Title
Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For VTE Following Total Joint Arthroplasty
Official Title
Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For Venous Thromboembolism (VTE) Following Total Joint Arthroplasty - A Multi-center Prospective Randomized Control Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
Chemoprophylaxis, Hip Surgery, Knee Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5478 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Once Daily
Arm Type
Experimental
Arm Description
Participant receives 81 mg aspirin taken once daily beginning the night before surgery and up to 28 days post surgery.
Arm Title
Treatment Twice Daily
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Non-enteric coated 81 mg Aspirin tablet.
Primary Outcome Measure Information:
Title
Incidence of symptomatic thromboembolic events
Description
Efficacy of prophylaxis will be reported as the number of reported incidence of symptomatic Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT).
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Incidence of specific adverse events
Description
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.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramakanth Yakkanti, MD
Phone
502-689-3127
Email
ramakanth.yakkanti@jhsmiami.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Hernandez, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramakanth Yakkanti
Phone
502-689-3127
Email
ramakanth.yakkanti1@jhsmiami.org
First Name & Middle Initial & Last Name & Degree
Victor Hernandez, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For VTE Following Total Joint Arthroplasty
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