Status:
UNKNOWN
The MUFFIN-PTS Trial
Lead Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
Conditions:
Post-Thrombotic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In this randomized controlled trial (RCT), the investigators will determine whether a 6-month course of oral Micronized Purified Flavonoid Fraction (MPFF 1000 mg daily), compared with placebo, improve...
Detailed Description
The post thrombotic syndrome (PTS) is a form of secondary chronic venous insufficiency (CVI) that develops after a deep vein thrombosis (DVT). It affects up to 50% of patients after a proximal DVT (i....
Eligibility Criteria
Inclusion
- Villalta score ≥5 with at least two of the following four PTS manifestations (daily heaviness, cramps, pain, and objective edema) in the leg ipsilateral to a previous objectively diagnosed DVT, or DVT of unknown date but with presence of residual proximal or distal venous obstruction on ultrasound. Females of childbearing age must use medically approved method of birth control and must have negative pregnancy test results at the time of randomization.
Exclusion
- Recent acute ipsilateral DVT (\<3 months)
- Active ipsilateral venous ulcer
- Acute or chronic altered mental status
- Any venoactive drug intake within 3 months of the start of the study
- Allergy or hypersensitivity to MPFF/Venixxa
- Age\<18 years
- Pregnant or breastfeeding women
- Life expectancy \<1 year
- Refuse or unwilling to provide consent
- Unable to speak English or French
- Alcohol/drug abuse
- Hospitalized patients
- End-stage kidney disease (dialysis, creatinine clearance \< 10ml/min)
- Liver cirrhosis Child-Pugh class C.
- Currently enrolled in other clinical trials, other than trials of prevention or treatment of venous thromboembolism
Key Trial Info
Start Date :
February 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2024
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03833024
Start Date
February 4 2022
End Date
May 30 2024
Last Update
November 30 2023
Active Locations (7)
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1
Vancouver General Hospital
Vancouver, British Columbia, Canada
2
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
3
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
4
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1Y 4E9