Use of oral colchicine to determine restenosis in the superficial femoral artery - the COLSTENT study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Uniwersytecki Szpital Kliniczny W Opolu

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

20 Nov 2025 → ongoing

Decision date (initial)

2024-04-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Agencja Badań Medycznych

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacogenetic, Pharmacoeconomic, Efficacy, Therapy, Safety

1. Evaluation of the effectiveness of oral colchicine to prevent restenosis in the superficial femoral artery in patients with lower extremity artery disease (LEAD) treated with an uncoated vascular stent in relation to local release of paclitaxel by drug-eluting stents
2. Assessment of the tolerance and safety of oral colchicine in the treatment of restenosis in patients with LEAD treated with an uncoated vascular stent in relation to the local release of paclitaxel by drug-eluting stents.

Secondary objectives 2

1. Evaluation of the effectiveness of oral colchicine in the secondary prevention of major adverse cardiovascular events (MACE) in patients with LEAD treated with an uncoated vascular stent in relation to local release of paclitaxel by drug-eluting stents
2. Identifying genetic changes that modify the therapeutic effect of colchicine and biomarkers for monitoring therapy

Conditions and MedDRA coding

Lower extremity artery disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Age >30 years
2. Chronic lower limb ischemia according to the Rutherford classification (grade 3-5)
3. Arteriographically diagnosed lesion in the superficial femoral artery l in the TASC A or TASC B classification, with occlusion or de novo lesion and/or restenosis of the superficial femoral artery ≥50% and ankle-brachial index (ABI) <0.90
4. Target lesion located at least 1 cm distal to the origin of the deep femoral artery and to the proximal border of the popliteal artery, not exceeding 3 cm above the patella
5. The reference diameter of the target vessel is ≥4.0 mm and ≤7.0 mm (visual assessment)
6. Patent popliteal artery and at least one patent calf artery
7. Postmenopausal or surgically sterile women with a written obligation to abstain from heterosexual sexual intercourse or to use two methods of contraception
8. Men with a written obligation to abstain from heterosexual sexual contact or use a contraceptive method (condom)
9. Signing informed consent to participate in a clinical trial
10. Signing informed consent to taking blood samples for genetic testing

Exclusion criteria 21

1. Previous vascular intervention in the area of the examined vessel
2. Hemodynamically significant stenosis in the common femoral artery on the examined side
3. Inflow disorders - changes in the aorta and iliac artery (patients after intervention in the iliac arteries are allowed)
4. The need to perform subintimate patency of the lesion
5. Presence of an aneurysm in the femoral and popliteal arteries
6. Contralateral superficial femoral artery lesions requiring intervention during the index procedure or within 30 days before or after the index procedure
7. The target lesion requires treatment other than standard PTA prior to stent placement (i.e., no other devices or procedures such as cutting balloons and atherectomy may be used during the index procedure)
8. Scheduled surgery within 30 days after the index procedure
9. A planned procedure that may result in noncompliance with the protocol or interfere with the interpretation of data
10. A trial participant is participating in another clinical trial involving drugs or devices that did not meet its primary endpoint or that, in the investigator's opinion, may result in noncompliance with the protocol or affect the interpretation of data
11. Pregnancy or breastfeeding
12. Presence of another serious disease (e.g. malignancy, congestive heart failure) with a life expectancy of less than 36 months
13. Presence of another serious chronic disease: kidney diseases (eGFR <50 ml/min), liver diseases (ALT >3 x normal, AST >3 x normal, bilirubin 3 x normal), chronic hepatitis B or C, HIV infection, hyperuricemia (URCA > upper limit of normal laboratory), creatine kinase level (> 4 x normal), blood diseases (leukopenia, granulocytopenia, anemia, thrombocytopenia), coagulation disorders, autoimmune diseases, inflammatory bowel disease, ulcerative colitis, comorbidities requiring chronic use of steroid drugs (chronic obstructive lung disease, asthma, rheumatoid arthritis) or non-steroidal anti-inflammatory drugs (NSAIDs)
14. No consent to transfusion of blood components
15. Resistance and/or allergy to clopidogrel, acetylsalicylic acid documented in the participant's medical history
16. Taking colchicine for other indications (e.g. gout, familial Mediterranean fever)
17. A history of an allergic reaction or significant sensitivity to colchicine
18. Taking immunosuppressive drugs, e.g. cyclosporine, methotrexate
19. Taking calcium channel blockers, e.g. verapamil, diltiazem
20. Taking selective serotonin reuptake inhibitors (SSRIs) for diseases such as depression, anxiety, neuropathic pain
21. Drug or alcohol abuse

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Patency of the superficial femoral artery after 24 months. Number of patients in whom the superficial femoral artery remained patency, i.e. blood flow in the artery assessed by Doppler ultrasound examination is three-phase and fast-flow 24 months after its implantation
2. Overall risk assessment of the procedure performed, defined as the number of subjects who experienced adverse events (AEs and SAEs), regardless of the potential connection with the stent implantation procedure or the pharmacotherapy used.

Secondary endpoints 12

1. Target Vessel Revascularization (TVR) over 24 months. Number of patients whose target vascular lesion in the superficial femoral artery required repeated revascularization within 24 months of stent implantation.
2. Late Lumen Loss (LLL) after 6 months. The value of the difference in mm between the minimum lumen diameter (MLD) in the stent immediately after stenting and the MLD 6 months after stent implantation.
3. Percentage narrowing of the vessel diameter in the stent after 24 months. Change estimated in % of the minimum lumen diameter in the stent (MLD) immediately after stenting and 24 months after stent implantation, determined by the formula [1−(MLD/reference vessel diameter)×100]
4. Improvement of the ankle-brachial index (ABI) after 24 months. Number of patients with an increase in the ankle-brachial index value by 0.1 during 24 months after stent implantation.
5. Improved Rutherford ischemia classification after 24 months. Number of patients whose ischemia classification on the Rutherford scale was reduced by one class within 24 months after stent implantation.
6. Occurrence of major amputation after 24 months. Number of patients who underwent amputation involving detachment of the ankle joint, amputation below/above the knee within 24 months of stent implantation.
7. Major adverse cardiovascular events (MACE) after 24 months. Number of patients who experienced myocardial infarction, coronary revascularization, ischemic stroke or death from cardiovascular causes within 24 months after stent implantation
8. Occurrence of death from cardiovascular causes after 24 months. Number of patients who died of cardiovascular causes within 24 months after stent implantation.
9. Number of days of hospitalization (all causes) during 24 months. Number of days of hospitalization of the patient for any reason within 24 months after stent implantation
10. Number of hospitalization days related to LEAD in the stented leg during 24 months. Number of days of patient hospitalization related to LEAD in the leg with an implanted stent, including repeated revascularization, amputation, etc. within 24 months of implantation
11. Improvement in ischemic pain intensity assessed using the NRS scale after 24 months. Reduction in the intensity of ischemic pain assessed using the NRS scale in relation to baseline values by 10 pp in the period of 24 months after stent implantation
12. Improvement in quality of life assessed using the VascuQol protocol at 24 months. An increase in the quality of life assessed using the VascuQol scale during the study compared to the baseline values by 10 pp in the 24 months after stent implantation

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Uniwersytecki Szpital Kliniczny W Opolu

Sponsor organisation

Uniwersytecki Szpital Kliniczny W Opolu

Address

Al. Wincentego Witosa 26

City

Opole

Postcode

45-401

Country

Poland

Scientific contact point

Organisation

Uniwersytecki Szpital Kliniczny W Opolu

Contact name

Uniwersyteckie Centrum Wsparcia Badań Klinicznych

Public contact point

Organisation

Uniwersytecki Szpital Kliniczny W Opolu

Contact name

Uniwersyteckie Centrum Wsparcia Badań Klinicznych

Third parties 1

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications