The MUFFIN-PTS Trial

NCT03833024 | Unknown Phase 3 DMC

• 1 other identifier: 332593-S1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 7

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, 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

Keywords

deep vein thrombosis; chronic venous insufficiency; venoactive drug; Micronized Purified Flavonoid Fraction; DVT; post thrombotic syndrome

Outcome Measures

Primary Outcomes (1)

• Change in PTS

  Improvement will be defined as a decrease of at least 30% in the Villalta score or a Villalta score \<5 in the PTS-affected leg.

  6 months

Secondary Outcomes (19)

• Severity of PTS

  baseline, 3, 6 and 9 months

• Change in PTS

  3 and 9 months

• Venous specific Quality of life

  3, 6 and 9 months

• General Quality of life

  3, 6 and 9 months

• Serious Adverse Events (SAE)

  9 months

Study Arms (2)

Venixxa

ACTIVE COMPARATOR

Micronized Purified Flavonoid Fraction (MPFF) for 6 months MPFF 500 mg, BID (morning and evening) for 6 months

Drug: Micronized Purified Flavonoid Fraction

Placebo

PLACEBO COMPARATOR

Placebo for 6 months 1 Tablet, BID (morning and evening) for 6 months

Drug: Placebo

Interventions

Micronized Purified Flavonoid Fraction DRUG

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

Also known as: Venixxa group

Venixxa

Placebo 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

Also known as: Placebo group

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (7)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 1Z5, Canada

Location

Sir Mortimer B. Davis - Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (9)

• Kahn SR, Pengo V. Special issue: Late consequences of venous thromboembolism. Thromb Res. 2018 Apr;164:99. doi: 10.1016/j.thromres.2018.02.005. Epub 2018 Feb 13. No abstract available.

  PMID: 29459016 BACKGROUND

• Rabinovich A, Kahn SR. How I treat the postthrombotic syndrome. Blood. 2018 May 17;131(20):2215-2222. doi: 10.1182/blood-2018-01-785956. Epub 2018 Mar 15.

  PMID: 29545327 BACKGROUND

• Kahn SR, Comerota AJ, Cushman M, Evans NS, Ginsberg JS, Goldenberg NA, Gupta DK, Prandoni P, Vedantham S, Walsh ME, Weitz JI; American Heart Association Council on Peripheral Vascular Disease, Council on Clinical Cardiology, and Council on Cardiovascular and Stroke Nursing. The postthrombotic syndrome: evidence-based prevention, diagnosis, and treatment strategies: a scientific statement from the American Heart Association. Circulation. 2014 Oct 28;130(18):1636-61. doi: 10.1161/CIR.0000000000000130. Epub 2014 Sep 22. No abstract available.

  PMID: 25246013 BACKGROUND

• Galanaud JP, Monreal M, Kahn SR. Epidemiology of the post-thrombotic syndrome. Thromb Res. 2018 Apr;164:100-109. doi: 10.1016/j.thromres.2017.07.026. Epub 2017 Jul 24.

  PMID: 28844444 BACKGROUND

• Cohen JM, Akl EA, Kahn SR. Pharmacologic and compression therapies for postthrombotic syndrome: a systematic review of randomized controlled trials. Chest. 2012 Feb;141(2):308-320. doi: 10.1378/chest.11-1175.

  PMID: 22315114 BACKGROUND

• Martinez-Zapata MJ, Vernooij RW, Uriona Tuma SM, Stein AT, Moreno RM, Vargas E, Capella D, Bonfill Cosp X. Phlebotonics for venous insufficiency. Cochrane Database Syst Rev. 2016 Apr 6;4(4):CD003229. doi: 10.1002/14651858.CD003229.pub3.

  PMID: 27048768 BACKGROUND

• Bush R, Comerota A, Meissner M, Raffetto JD, Hahn SR, Freeman K. Recommendations for the medical management of chronic venous disease: The role of Micronized Purified Flavanoid Fraction (MPFF). Phlebology. 2017 Apr;32(1_suppl):3-19. doi: 10.1177/0268355517692221.

  PMID: 28211296 BACKGROUND

• Rabe E, Agus GB, Roztocil K. Analysis of the effects of micronized purified flavonoid fraction versus placebo on symptoms and quality of life in patients suffering from chronic venous disease: from a prospective randomized trial. Int Angiol. 2015 Oct;34(5):428-36. Epub 2015 May 14.

  PMID: 25972136 BACKGROUND

• Galanaud JP, Abdulrehman J, Lazo-Langner A, Le Gal G, Shivakumar S, Schulman S, Kahn S. MUFFIN-PTS trial, Micronized Purified Flavonoid Fraction for the Treatment of Post-Thrombotic Syndrome: protocol of a randomised controlled trial. BMJ Open. 2021 Sep 13;11(9):e049557. doi: 10.1136/bmjopen-2021-049557.

  PMID: 34518263 DERIVED

MeSH Terms

Conditions

Postthrombotic Syndrome; Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Study Officials

• Susan R Kahn, MD, MSc

  Jewish General Hospital (Montreal, Quebec, Canada)

  PRINCIPAL INVESTIGATOR

• Jean-Philippe Galanaud, MD, PhD

  Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind placebo-controlled trial with oral placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Multicentre, randomized, placebo-controlled trial

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 6, 2019
• Study Start: February 4, 2022
• Primary Completion: March 30, 2024
• Study Completion: May 30, 2024
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)