Overview
Sponsor-declared trial summary
Ischemia of the lower limbs in the course of obstructive artery disease
The main goal of this study is to investigate the influence of the use of cysteinyl leukotrienes receptor antagonists on lower limbs arteries reocclusion rate in patients with peripheral artery occlusive disease (PAOD) after endovascular treatment.
Key facts
- Sponsor
- Uniwersytet Jagiellonski Collegium Medicum
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 19 Aug 2021 → ongoing
- Decision date (initial)
- 2024-07-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511894-32-00
- EudraCT number
- 2020-000715-71
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Safety
The main goal of this study is to investigate the influence of the use of cysteinyl leukotrienes receptor antagonists on lower limbs arteries reocclusion rate in patients with peripheral artery occlusive disease (PAOD) after endovascular treatment.
Secondary objectives 1
- Assessment of the improvement in the quality of life patients treated endovascularly for ischemia of the lower limbs caused by the use of a leukotriene receptor antagonist (montelukast).
Conditions and MedDRA coding
Ischemia of the lower limbs in the course of obstructive artery disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10067825 | Peripheral arterial disease | 10047065 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Patients with PAOD qualified for PTAvin the Angiology Department UJ CM, with Rutherford 3 or 4 clinical symptoms.
- Age 45 - 75 years old.
- Signed informed consent.
- Citizen of Malopolska region
Exclusion criteria 21
- Patients with peripheral arterial disease (PAOD) with Rutherford 1,2,5 or 6 clinical symptoms.
- Age < 45 or > 75 years old.
- Infection and/or fever (temperature above 37,2 C) within the last 3 weeks preceding the study recruitment (viral infections, cold, sinusitis) and use of antibiotics within the last 2 months.
- Symptoms of acute tissue infection
- Chronic inflammatory disease (e.g. COPD stage >II in GOLD classification)
- HIV+, HCV+, HBS+.
- Autoimmunological diseases and use of steroids or immunosuppressive medications within the last 3 months.
- Inflammatory blood vessel disorders (with exception of atherosclerosis)
- Myocardial infarction or stoke within last 6 months.
- Buerger Disease.
- Chronic heart failure (3-4 NYHA)
- Acute lower limb ischemia or surgical revascularization within last 6 months.
- Serious trauma or surgery procedure within last 6 months.
- Asthma.
- Ongoing antileukotriene treatment
- Neoplasm diagnosed within 5 years.
- Chronic Kidney Disease (creat. >177 μmol/l).
- Pregnancy, puerperium, women without efficient contraception.
- Vaccinations within 30 days before recruitment.
- Hospitalisation in intensive care unit within 3 months.
- Lack of the possibility of the follow-up participation.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Restenosis in a previously treated artery
Secondary endpoints 1
- MACE, high lower limb amputation, significant loss in quality of life
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Asmenol, 10 mg, tabletki powlekane
PRD447413 · Product
- Active substance
- Montelukast
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03DC03 — MONTELUKAST
- Marketing authorisation
- 14972
- MA holder
- ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- change of packaging (blinding)
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Uniwersytet Jagiellonski Collegium Medicum
- Sponsor organisation
- Uniwersytet Jagiellonski Collegium Medicum
- Address
- Ul. Sw. Anny 12
- City
- Cracow
- Postcode
- 31-008
- Country
- Poland
Scientific contact point
- Organisation
- Uniwersytet Jagiellonski Collegium Medicum
- Contact name
- Paweł Maga
Public contact point
- Organisation
- Uniwersytet Jagiellonski Collegium Medicum
- Contact name
- Biuro ds badan klinicznych
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruitment ended | 200 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Poland | 2021-08-19 | 2021-10-06 | 2025-05-31 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-24 | Poland | Acceptable 2024-06-26
|
2024-07-01 |