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The MUFFIN-PTS Trial (MUFFIN-PTS)

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ClinicalTrials.gov Identifier: NCT03833024
Recruitment Status : Not yet recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Susan Kahn, Sir Mortimer B. Davis - Jewish General Hospital

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.

Condition or disease Intervention/treatment Phase
Post-Thrombotic Syndrome Drug: Micronized Purified Flavonoid Fraction Drug: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicentre, randomized, placebo-controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double-blind placebo-controlled trial with oral placebo
Primary Purpose: Treatment
Official Title: The MUFFIN-PTS Trial: Micronized Purified Flavonoid Fraction for the Treatment of Post-Thrombotic Syndrome
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : June 1, 2021

Arm Intervention/treatment
Active Comparator: Venixxa
Micronized Purified Flavonoid Fraction (MPFF) for 6 months MPFF 500 mg, BID (morning and evening) for 6 months
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
Other Name: Venixxa group

Placebo Comparator: Placebo

Placebo for 6 months

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

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
Other Name: Placebo group




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Severity of PTS [ Time Frame: baseline, 3, 6 and 9 months ]
    Villalta score category (mild, moderate, severe)

  2. Change in PTS [ Time Frame: 3 and 9 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.

  3. Venous specific Quality of life [ Time Frame: 3, 6 and 9 months ]
    Venous-disease specific (VEINES-QOL) score

  4. General Quality of life [ Time Frame: 3, 6 and 9 months ]
    Generic QOL (SF-36) score

  5. Serious Adverse Events (SAE) [ Time Frame: 9 months ]
    Includes drug-related SAE, DVT, Pulmonary Embolism (PE), death

  6. Patient compliance with treatment [ Time Frame: 3 and 6 months ]
    Judged satisfactory if at least 80% of the study drug was reportedly taken

  7. Patients' overall satisfaction with treatment [ Time Frame: 3 and 6 months ]
    Assessed with a 5-point Likert visual analog scale questionnaire (1 indicate patient is very satisfied with treatment and 5 that he is very unsatisified)

  8. Villalta score [ Time Frame: 3, 6, 9 months ]
    Villalta score assessed as a continuous variable (greater score indicates more severe disease, score range 0 to 33)

  9. Pain [ Time Frame: 3, 6, 9 months ]
    Analyzed as individual component of Villalta score (0 absent to 3 severe)

  10. Cramps [ Time Frame: 3, 6, 9 months ]
    Analyzed as individual component of Villalta score (0 absent to 3 severe)

  11. Heaviness [ Time Frame: 3, 6, 9 months ]
    Analyzed as individual component of Villalta score (0 absent to 3 severe)

  12. Paresthesia [ Time Frame: 3, 6, 9 months ]
    Analyzed as individual component of Villalta score (0 absent to 3 severe)

  13. Pruritus [ Time Frame: 3, 6, 9 months ]
    Analyzed as individual component of Villalta score (0 absent to 3 severe)

  14. Pre-tibial edema [ Time Frame: 3, 6, 9 months ]
    Analyzed as individual component of Villalta score (0 absent to 3 severe)

  15. Hyperpigmentation [ Time Frame: 3, 6, 9 months ]
    Analyzed as individual component of Villalta score (0 absent to 3 severe)

  16. Redness [ Time Frame: 3, 6, 9 months ]
    Analyzed as individual component of Villalta score (0 absent to 3 severe)

  17. Skin induration [ Time Frame: 3, 6, 9 months ]
    Analyzed as individual component of Villalta score (0 absent to 3 severe)

  18. Venous ectasia [ Time Frame: 3, 6, 9 months ]
    Analyzed as individual component of Villalta score (0 absent to 3 severe)

  19. Venous Ulcer [ Time Frame: 3, 6, 9 months ]
    Analyzed as individual component of Villalta score (0 absent or 1 present)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Villalta score >4 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833024


Contacts
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Contact: Susan R Kahn, MD, MSc 514-340-8222 ext 22790 susan.kahn@mcgill.ca
Contact: Jean-Philippe Galanaud, MD, PhD 514-340-8222 ext 22790 Jean-Philippe.Galanaud@sunnybrook.ca

Locations
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Canada, Quebec
Sir Mortimer B. Davis - Jewish General Hospital Not yet recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Susan R. Kahn, M.D., M.Sc.    514-340-8222 ext 24667      
Principal Investigator: Susan R. Kahn, M.D., M.Sc.         
Sponsors and Collaborators
Sir Mortimer B. Davis - Jewish General Hospital
Investigators
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Principal Investigator: 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

Publications:

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Responsible Party: Dr. Susan Kahn, Professor of Medicine, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT03833024     History of Changes
Other Study ID Numbers: 332593-S1
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Susan Kahn, Sir Mortimer B. Davis - Jewish General Hospital:
deep vein thrombosis
chronic venous insufficiency
venoactive drug
Micronized Purified Flavonoid Fraction
DVT
post thrombotic syndrome

Additional relevant MeSH terms:
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Syndrome
Postthrombotic Syndrome
Postphlebitic Syndrome
Disease
Pathologic Processes
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases