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The MUFFIN-PTS Trial

NCT ID: NCT03833024

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-04

Study Completion Date

2024-05-30

Brief Summary

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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.

Detailed Description

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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.e. DVT involving popliteal vein or more proximal veins), and 5-10% of patients develop severe PTS. PTS is a chronic condition that reduces quality of life (QOL) and for which no curative treatment is available. Cornerstones of PTS treatment include the use of elastic compression stockings (ECS) to reduce leg symptoms and prevent PTS progression. However, ECS are incompletely effective, burdensome and costly to patients. Micronized Purified Flavonoid Fraction (MPFF, Venixxa), a venoactive drug, has been reported to be effective in reducing venous symptoms and signs and improving QOL in patients with CVI and has the potential to be effective for the treatment of PTS. Further, use of Venixxa is safe, with only few very mild and reversible reported side effects. However, studies of MPFF in patients with CVI have been of low to moderate quality, and there has been little use of this drug in North America. In addition, the effectiveness of MPFF has never been specifically evaluated in patients with PTS. Given that the pathophysiological mechanism of PTS is complex and unique (combination of obstructive and reflux mechanisms as well as inflammation), it is uncertain if MPFF is effective in patients with PTS, even if it may be effective for CVI more generally.

The MUFFIN-PTS study will be a multicentre (8-10 centres), randomized, placebo-controlled trial. Patients will be randomized (1:1 with stratification by centre) to receive 1000 mg of oral MPFF (Venixxa, one 500mg tablet BID) or an identically appearing placebo (one tablet BID) for 6 months, in addition to their usual PTS and DVT treatment (i.e. ECS and/or anticoagulation, at their treating physician's discretion). Its objectives are to evaluate the effectiveness and safety of MPFF (Venixxa) compared to placebo for the treatment of PTS.

86 patients with lower limb PTS will be enrolled in the study.

Conditions

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Post-Thrombotic Syndrome

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicentre, randomized, placebo-controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Double-blind placebo-controlled trial with oral placebo

Study Groups

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Venixxa

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

Group Type ACTIVE_COMPARATOR

Micronized Purified Flavonoid Fraction

Intervention Type 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

Placebo

Placebo for 6 months

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Venixxa group Placebo group

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sir Mortimer B. Davis - Jewish General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Susan Kahn

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan R Kahn, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Jewish General Hospital (Montreal, Quebec, Canada)

Jean-Philippe Galanaud, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Locations

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Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Sir Mortimer B. Davis - Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 29459016 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29545327 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25246013 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28844444 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22315114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27048768 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28211296 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25972136 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34518263 (View on PubMed)

Other Identifiers

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332593-S1

Identifier Type: -

Identifier Source: org_study_id