A study of the anti-inflammatory medication colchicine for people with blocked arteries of the legs
- Conditions
- Peripheral artery diseaseCirculatory System
- Registration Number
- ISRCTN99954716
- Lead Sponsor
- niversity of Bristol
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 6150
Patients need to meet the following criteria for inclusion:
1. Age > 18 years old
2. Symptomatic atherosclerotic LE PAD fulfilling at least one of the following:
2.1. Intermittent claudication with ankle/arm blood pressure ratio* (ABI = 0.90) or artery stenosis = 50% plus one of
2.1.1. >1 vascular bed affected by atherosclerosis.
2.1.2. Diabetes
2.1.3. Heart failure
2.1.4. Chronic kidney disease (eGFR < 60 mL/min/1.73 m2)
2.2. Rest pain (mostly in the foot) OR necrosis of limb OR gangrene of limb (corresponding to either Fontaine stages 3 or 4 OR Rutherford Classification categories 4 to 6). All must have an ankle/arm blood pressure ratio* (ABI = 0.90) OR artery stenosis = 50%.
*In cases of incompressible ankle arteries, the presence of toe pressure = 60 mm Hg or toe-brachial index = 0.70 is acceptable
2.3. Revascularization, defined as limb bypass surgery or endovascular revascularization procedures (irrespective of the specific device used), including percutaneous transluminal angioplasty/stent of iliac or infra-inguinal arteries or extra-anatomical bypass surgery.
2.4. Leg or foot amputation for arterial vascular indications
3. Written or verbal informed consent from the patient
1. Contraindication to colchicine
2. Long-term requirement for colchicine for another clinical indication
3. Active diarrhoea
4. eGFR < 30 mL/min/1.73 m2 (based on the local method for estimating eGFR)
5. Cirrhosis or severe chronic liver disease
6. Woman who is pregnant, breast-feeding or of child-bearing potential not protected by reliable contraception or is planning conception during the study
7. Current or planned long-term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (except azithromycin)
8. Patients who are deemed unlikely to return for follow-up
9. Patients with life expectancy < 1 year
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of major adverse cardiovascular and limb events (MACE or MALE). This composite outcome consists of cardiovascular deaths, myocardial infarction, stroke, and severe limb ischemia that requires a vascular intervention (i.e., pharmacological reperfusion, endovascular or surgical revascularisation) or a major vascular amputation (defined as ankle/transtibial amputation or higher). Details of these events will be collected at 6 monthly follow-up visits for the duration of participation via participant reports and using information in participant medical records. The trial is event-driven with the final analysis planned once 731 primary events have occurred.
- Secondary Outcome Measures
Name Time Method Major adverse cardiovascular events, major adverse limb events (MALE), extended MALE, cardiovascular deaths, myocardial infarction, stroke, hospitalisation, acute or chronic limb-threatening ischemia, all revascularisation (defined as coronary or cerebrovascular or lower limb or other peripheral revascularisation), total vascular amputation, overall mortality, all thrombosis or thromboembolism (arterial and venous), Fontaine Stage. Details of these events will be collected at 6 monthly follow-up visits using for the duration of participation via participant reports and using information in participant medical records.<br><br>EQ-5D-5L, VascuQOL-6 and Standard Assessment of Global Everyday Activities (SAGEA) will be completed by participants at randomisation, and every 12 months for the duration of participation.<br>