Post-Thrombotic SyndromePhase 3MUFFIN-PTSNCT03833024
The MUFFIN-PTS Trial
A Phase 3 study testing Micronized Purified Flavonoid Fraction in people with Post-Thrombotic Syndrome, run by Sir Mortimer B. Davis - Jewish General Hospital at 7 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Thrombotic Syndrome
- What is being tested?
- Micronized Purified Flavonoid Fraction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 7 sitesCanada
- Study dates
- 4 Feb 2022to 30 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, H3T 1E2
Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 4E9
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Toronto General Hospital
Toronto, Ontario, M5G 1Z5
Vancouver General Hospital
Vancouver, British Columbia
About this study
Official title: The MUFFIN-PTS Trial: Micronized Purified Flavonoid Fraction for the Treatment of Post-Thrombotic Syndrome
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.
Read the 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.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
- Post-Thrombotic Syndrome
- Being tested
- Micronized Purified Flavonoid Fraction, Placebo
- Keywords
- deep vein thrombosis, chronic venous insufficiency, venoactive drug, Micronized Purified Flavonoid Fraction, DVT, post thrombotic syndrome
- Medical subject headings
- Postthrombotic Syndrome, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronized Purified Flavonoid FractionDrug
Also called Venixxa group
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
PlaceboDrug
Also called Placebo group
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
| Study group | Role | What they receive |
|---|---|---|
| Venixxa | Active comparator | Micronized Purified Flavonoid Fraction (MPFF) for 6 months MPFF 500 mg, BID (morning and evening) for 6 months Receives: Drug: Micronized Purified Flavonoid Fraction |
| Placebo | Placebo comparator | Placebo for 6 months
1 Tablet, BID (morning and evening) for 6 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (19)
Severity of PTS
Villalta score category (mild, moderate, severe)
Measured: baseline, 3, 6 and 9 months
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.
Measured: 3 and 9 months
Venous specific Quality of life
Venous-disease specific (VEINES-QOL) score
Measured: 3, 6 and 9 months
General Quality of life
Generic QOL (EQ-5D-5L) score. The EQ-5D-5L consists of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.
The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. This information can be used as a quantitative measure of health as judged by the individual respondents.
Measured: 3, 6 and 9 months
Serious Adverse Events (SAE)
Includes drug-related SAE, DVT, Pulmonary Embolism (PE), death
Measured: 9 months
Patient compliance with treatment
Judged satisfactory if at least 80% of the study drug was reportedly taken
Measured: 3 and 6 months
Patients' overall satisfaction with treatment
Assessed with a 5-point Likert visual analog scale questionnaire (1 indicate patient is very satisfied with treatment and 5 that he is very unsatisfied)
Measured: 3 and 6 months
Villalta score
Villalta score assessed as a continuous variable (greater score indicates more severe disease, score range 0 to 33)
Measured: 3, 6, 9 months
Pain as a symptom of PTS
Analyzed as individual component of Villalta score (0 absent to 3 severe)
Measured: 3, 6, 9 months
Cramps
Analyzed as individual component of Villalta score (0 absent to 3 severe)
Measured: 3, 6, 9 months
Heaviness
Analyzed as individual component of Villalta score (0 absent to 3 severe)
Measured: 3, 6, 9 months
Paresthesia
Analyzed as individual component of Villalta score (0 absent to 3 severe)
Measured: 3, 6, 9 months
Pruritus
Analyzed as individual component of Villalta score (0 absent to 3 severe)
Measured: 3, 6, 9 months
Pre-tibial edema
Analyzed as individual component of Villalta score (0 absent to 3 severe)
Measured: 3, 6, 9 months
Hyperpigmentation
Analyzed as individual component of Villalta score (0 absent to 3 severe)
Measured: 3, 6, 9 months
Redness
Analyzed as individual component of Villalta score (0 absent to 3 severe)
Measured: 3, 6, 9 months
Skin induration
Analyzed as individual component of Villalta score (0 absent to 3 severe)
Measured: 3, 6, 9 months
Venous ectasia
Analyzed as individual component of Villalta score (0 absent to 3 severe)
Measured: 3, 6, 9 months
Venous Ulcer
Analyzed as individual component of Villalta score (0 absent or 1 present)
Measured: 3, 6, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start4 Feb 2022
- Primary completion30 Mar 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Post-Thrombotic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, randomized, placebo-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Susan Kahn, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Susan R Kahn, MD, MSc, Principal investigator, Jewish General Hospital (Montreal, Quebec, Canada)Jean-Philippe Galanaud, MD, PhD, Principal investigator, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833024
- Sponsor's protocol ID
- 332593-S1
- Acronym
- MUFFIN-PTS
- Status last verified
- Nov 2023
- First submitted
- 30 Jan 2019
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Open access to individual patient data is not planned, but all requests for the trial's data will be considered on an individual basis by the trial steering committee
Publications
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.
PubMed 29459016Rabinovich 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.
PubMed 29545327Kahn 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.
PubMed 25246013Galanaud 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.
PubMed 28844444Cohen 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.
PubMed 22315114Martinez-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.
PubMed 27048768Bush 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.
PubMed 28211296Rabe 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.
PubMed 25972136Galanaud 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.
PubMed 34518263
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MUFFIN-PTS Trial: Micronized Purified Flavonoid Fraction for the Treatment of Post-Thrombotic Syndrome
- ClinicalTrials.gov ID
- NCT03833024
- Acronym / sponsor ID
- MUFFIN-PTS / 332593-S1
- Conditions
- Post-Thrombotic Syndrome
- Keywords
- deep vein thrombosis, chronic venous insufficiency, venoactive drug, Micronized Purified Flavonoid Fraction, DVT, post thrombotic syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre, randomized, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Venixxa | Active comparator | Drug: Micronized Purified Flavonoid FractionMicronized Purified Flavonoid Fraction (MPFF) for 6 months MPFF 500 mg, BID (morning and evening) for 6 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for 6 months 1 Tablet, BID (morning and evening) for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micronized Purified Flavonoid FractionAlso: Venixxa groupAfter 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 | Venixxa |
| PlaceboAlso: Placebo groupAfter 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 | Drug | Placebo |
Primary outcome
Change in PTS
Time frame: 6 months
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.
19 secondary outcomes
Severity of PTS
Time frame: baseline, 3, 6 and 9 months
Change in PTS
Time frame: 3 and 9 months
Venous specific Quality of life
Time frame: 3, 6 and 9 months
General Quality of life
Time frame: 3, 6 and 9 months
Serious Adverse Events (SAE)
Time frame: 9 months
Patient compliance with treatment
Time frame: 3 and 6 months
Patients' overall satisfaction with treatment
Time frame: 3 and 6 months
Villalta score
Time frame: 3, 6, 9 months
Pain as a symptom of PTS
Time frame: 3, 6, 9 months
Cramps
Time frame: 3, 6, 9 months
Heaviness
Time frame: 3, 6, 9 months
Paresthesia
Time frame: 3, 6, 9 months
Pruritus
Time frame: 3, 6, 9 months
Pre-tibial edema
Time frame: 3, 6, 9 months
Hyperpigmentation
Time frame: 3, 6, 9 months
Redness
Time frame: 3, 6, 9 months
Skin induration
Time frame: 3, 6, 9 months
Venous ectasia
Time frame: 3, 6, 9 months
Venous Ulcer
Time frame: 3, 6, 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Background: PubMed 29459016Kahn 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.
- Background: PubMed 29545327Rabinovich 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.
- Background: PubMed 25246013Kahn 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.
- Background: PubMed 28844444Galanaud 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.
- Background: PubMed 22315114Cohen 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.
- Background: PubMed 27048768Martinez-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.
- Background: PubMed 28211296Bush 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.
- Background: PubMed 25972136Rabe 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.
- Derived from this study: PubMed 34518263Galanaud 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.
- Individual participant dataSharing planned: No. Open access to individual patient data is not planned, but all requests for the trial's data will be considered on an individual basis by the trial steering committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan R Kahn, MD, MSc principal investigator
Jewish General Hospital (Montreal, Quebec, Canada)
Jean-Philippe Galanaud, MD, PhD principal investigator
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Micronized Purified Flavonoid Fraction in people with Post-Thrombotic Syndrome, run by Sir Mortimer B. Davis - Jewish General Hospital at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03833024, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.