Low dose ColchicinE in pAtients with peripheral artery DiseasE to address residual vascular Risk: A randomized trial- LEADER PAD

Conditions

Peripheral arterial disease

Brief summary

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 revascularization) or a major vascular amputation (defined as ankle/transtibial amputation or higher).

Detailed description

Extended MALE; This composite outcome includes major adverse limb events (MALE) as well as revascularization for new or worsening claudication of new stenosis or occlusion detected on screening after a previous intervention, Cardiovascular death, Myocardial infarction, Stroke, Hospitalization, Acute or chronic limb-threatening ischemia, All revascularization (coronary or cerebrovascular or lower limb or other peripheral revascularization), Total vascular amputation, Overall mortality, Any thrombosis or thromboembolism (arterial and venous), Fontaine Stage, Standard Assessment of Global Everyday Activities (SAGEA), Vascular Quality of Life Questionnaire-6 (VascQOL-6), EuroQol 5 Dimension 5 Level (EQ-5D-5L)

Related papers

No related papers found yet.

Interventions

DRUGColchicine Tiofarma 500 microgram Tablets

DRUGPlacebo matching Tiofarma colchicine 500 mcg tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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 revascularization) or a major vascular amputation (defined as ankle/transtibial amputation or higher).	—

Secondary

Measure	Time frame
Extended MALE; This composite outcome includes major adverse limb events (MALE) as well as revascularization for new or worsening claudication of new stenosis or occlusion detected on screening after a previous intervention, Cardiovascular death, Myocardial infarction, Stroke, Hospitalization, Acute or chronic limb-threatening ischemia, All revascularization (coronary or cerebrovascular or lower limb or other peripheral revascularization), Total vascular amputation, Overall mortality, Any thrombosis or thromboembolism (arterial and venous), Fontaine Stage, Standard Assessment of Global Everyday Activities (SAGEA), Vascular Quality of Life Questionnaire-6 (VascQOL-6), EuroQol 5 Dimension 5 Level (EQ-5D-5L)	—

Measure

Time frame

Extended MALE; This composite outcome includes major adverse limb events (MALE) as well as revascularization for new or worsening claudication of new stenosis or occlusion detected on screening after a previous intervention, Cardiovascular death, Myocardial infarction, Stroke, Hospitalization, Acute or chronic limb-threatening ischemia, All revascularization (coronary or cerebrovascular or lower limb or other peripheral revascularization), Total vascular amputation, Overall mortality, Any thrombosis or thromboembolism (arterial and venous), Fontaine Stage, Standard Assessment of Global Everyday Activities (SAGEA), Vascular Quality of Life Questionnaire-6 (VascQOL-6), EuroQol 5 Dimension 5 Level (EQ-5D-5L)

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Countries

Belgium, Italy, Netherlands

Outcome results

None listed