The MUFFIN-PTS Trial
NCT03833024 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2023-11-30
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, improves the symptoms and signs of the post-thrombotic syndrome (PTS) and quality of life (QOL) at 6 months follow-up.
Conditions
- Post-Thrombotic Syndrome
Interventions
- DRUG
-
Micronized Purified Flavonoid Fraction
After randomization (1:1 with stratification by centre) patients will receive 1000 mg of oral MPFF (Venixxa, one 500mg tablet BID) for 6 months, in addition to their usual PTS and DVT treatment
- DRUG
-
After randomization (1:1 with stratification by centre) patients will receive an oral placebo (one tablet BID) for 6 months, in addition to their usual PTS and DVT treatment
Sponsors & Collaborators
-
Sir Mortimer B. Davis - Jewish General Hospital
lead OTHER
Principal Investigators
-
Susan R Kahn, MD, MSc · Jewish General Hospital (Montreal, Quebec, Canada)
-
Jean-Philippe Galanaud, MD, PhD · Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-04
- Primary Completion
- 2024-03-30
- Completion
- 2024-05-30
Countries
- Canada
Study Locations
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