Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-01 @ 8:20 PM
Study NCT ID:
NCT04774159
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2021-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003078', 'term': 'Colchicine'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind and use of similarly active and placebo tablets.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2021-02-21', 'studyFirstSubmitQcDate': '2021-02-24', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Occurrence of gastrointestinal toxicity (such as diarrhoea, nausea or vomiting) that results in study drug discontinuation', 'timeFrame': '3-5 years', 'description': 'Safety outcome'}, {'measure': 'Muscle pain (myalgia or myositis), that results in study drug discontinuation', 'timeFrame': '3-5 years', 'description': 'Safety outcome'}, {'measure': 'Infection (e.g., pneumonia) leading to hospitalization', 'timeFrame': '3-5 years', 'description': 'Safety outcome'}, {'measure': 'New diagnosis of cancer', 'timeFrame': '3-5 years', 'description': 'Safety outcome'}, {'measure': 'Renal insufficiency (defined as the need for dialysis or kidney transplant)', 'timeFrame': '3-5 years', 'description': 'Other outcomes of interest'}, {'measure': 'Neuropathy leading to study drug discontinuation', 'timeFrame': '3-5 years', 'description': 'Other outcomes of interest'}, {'measure': 'Neutropenia leading to study drug discontinuation', 'timeFrame': '3-5 years', 'description': 'Other outcomes of interest'}, {'measure': 'Bleeding', 'timeFrame': '3-5 years', 'description': 'Other outcomes of interest'}], 'primaryOutcomes': [{'measure': 'Major adverse cardiovascular and limb events (MACE or MALE)', 'timeFrame': '3-5 years', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Extended MALE', 'timeFrame': '3-5 years', 'description': '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'}, {'measure': 'Cardiovascular death', 'timeFrame': '3-5 years', 'description': 'Death will be classified as cardiovascular or non-cardiovascular. All deaths with a clear cardiovascular or unknown cause will be classified as cardiovascular. Only deaths due to a documented non-cardiovascular cause (e.g., cancer) will be classified as non-cardiovascular.'}, {'measure': 'Myocardial infarction', 'timeFrame': '3-5 years', 'description': 'Acute myocardial infarction (AMI) requires evidence of acute myocardial injury with clinical evidence of acute myocardial ischemia'}, {'measure': 'Stroke', 'timeFrame': '3-5 years', 'description': 'Stroke requires the presence of acute focal or global\\* neurological dysfunction caused by brain or retinal vascular injury due to primary hemorrhage or infarction.'}, {'measure': 'Hospitalization', 'timeFrame': '3-5 years', 'description': 'Admission to hospital for any reason'}, {'measure': 'Acute or chronic limb-threatening ischemia', 'timeFrame': '3-5 years', 'description': 'This is defined as an episode severe limb ischemia that requires an acute vascular intervention (i.e., pharmacological reperfusion, endovascular or surgical revascularization) or a major vascular amputation (defined as at ankle or transtibial amputation or higher).'}, {'measure': 'All revascularization coronary or cerebrovascular or lower limb or other peripheral revascularization)', 'timeFrame': '3-5 years', 'description': 'Defined as coronary or cerebrovascular or lower limb or other peripheral revascularization'}, {'measure': 'Total vascular amputation', 'timeFrame': '3-5 years', 'description': 'All vascular amputations'}, {'measure': 'Overall mortality', 'timeFrame': '3-5 years', 'description': 'All cause (CV and non CV) deaths'}, {'measure': 'Any thrombosis or thromboembolism (arterial and venous)', 'timeFrame': '3-5 years', 'description': 'All arterial and venous thromboembolism'}, {'measure': 'Fontaine Stage', 'timeFrame': '3-5 years', 'description': 'This classification system grades the clinical presentation of patients to four stages of PAD'}, {'measure': 'Standard Assessment of Global Everyday Activities (SAGEA)', 'timeFrame': '3-5 years', 'description': 'The Standard Assessment of Global Everyday Activities (SAGEA) is a 15 item tool to assess activities of daily living including higher executive function used in social situations, everyday activities and basic activities of daily living. Scores range from 0 to 24 with higher scores indicating poorer function.It is a 15 items questionnaire and the scores will range from 0, describing a very independent participant over a broad spectrum of activities, to 48 describing a very dependent participant'}, {'measure': 'Vascular Quality of Life Questionnaire-6 (VascQOL-6)', 'timeFrame': '3-5 years', 'description': 'Six item vascular quality of life instrument: The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status.'}, {'measure': 'EuroQol 5 Dimension 5 Level (EQ-5D-5L)', 'timeFrame': '3-5 years', 'description': 'A survey that measures quality of life across 5 domains. Each domain is scored on a 5-level severity ranking that ranges from "no problems" to "extreme problems".'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute limb ischemia', 'Myocardial Infarction', 'Stroke', 'Cardiovascular death', 'Mortality'], 'conditions': ['Peripheral Arterial Disease', 'Atherosclerosis of Extremities', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'The Low dose ColchicinE in pAtients with peripheral Artery DiseasE to address residual vascular Risk (LEADER-PAD) trial will evaluate if anti-inflammatory therapy with colchicine will reduce vascular events in patients with symptomatic peripheral artery disease.', 'detailedDescription': 'The LEADER-PAD trial is a randomized, double blind, multicenter trial with an active run-in period, comparing low dose colchicine 0.5 mg daily with placebo in patients with symptomatic peripheral artery disease (PAD) to prevent vascular events (myocardial infarction, stroke, cardiovascular deaths, acute limb ischemia and vascular amputation). The sample size for the trial is 6,150 participants. The primary outcome for the trial is major adverse cardiovascular and limb events (MACE and MALE). This composite outcome consists of cardiovascular death, 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Age \\> 18 years\n2. Symptomatic atherosclerotic LE PAD fulfilling at least one of the following:\n\n a. Intermittent claudication with ankle/arm blood pressure ratio\\* (ABI ≤ 0.90) or artery stenosis ≥ 50% plus one of i. \\>1 vascular bed affected by atherosclerosis ii. Diabetes iii. Heart failure iv. Chronic kidney disease (eGFR \\< 60 mL/min/1.73 m2)\n\n b. Rest pain (mostly in 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%.\n\n \\* In cases of incompressible ankle arteries, the presence of toe pressure ≤ 60 mm Hg or toe-brachial index ≤ 0.70 is acceptable\n\n c. 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\n\n d. Leg or foot amputation for arterial vascular indications\n3. Written or verbal informed consent from the patient\n\nExclusion Criteria:\n\n1. Contraindication to colchicine\n2. Long term requirement for colchicine for another clinical indication\n3. Active diarrhoea\n4. eGFR \\< 30 mL/min/1.73 m2\n5. Cirrhosis or severe chronic liver disease\n6. Woman who is pregnant, or breast-feeding or of child-bearing potential not protected by reliable contraception or is planning conception during the study\n7. Current or planned long term use of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics (with the exception of azithromycin)\n8. Patients who are deemed unlikely to return for follow-up\n9. Patients with life expectancy \\< 1 year'}, 'identificationModule': {'nctId': 'NCT04774159', 'acronym': 'LEADER-PAD', 'briefTitle': 'Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk', 'organization': {'class': 'OTHER', 'fullName': 'Population Health Research Institute'}, 'officialTitle': 'Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk: A Randomized Trial', 'orgStudyIdInfo': {'id': 'LEADER-PAD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Colchicine', 'description': 'Colchicine 0.5mg daily for the duration of the trial', 'interventionNames': ['Drug: Colchicine 0.5 MG Oral Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Colchicine-Placebo', 'description': 'Colchicine-Placebo daily', 'interventionNames': ['Drug: Colchicine-Placebo']}], 'interventions': [{'name': 'Colchicine 0.5 MG Oral Tablet', 'type': 'DRUG', 'otherNames': ['Colchicine'], 'description': 'Colchicine 0.5 mg tablet daily\n\nActive drug and placebo are of the same appearance and are indistinguishable. All investigators, study personnel and patients will be blinded to drug treatment assignment. Trial treatment supplies must be stored in a secure, limited-access location under the storage conditions specified on the IP supply label.', 'armGroupLabels': ['Colchicine']}, {'name': 'Colchicine-Placebo', 'type': 'DRUG', 'otherNames': ['Colchicine-Placebo tablet'], 'description': 'Colchicine-Placebo tablet', 'armGroupLabels': ['Colchicine-Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Emi Sanders', 'role': 'CONTACT'}, {'name': 'Caleb Zavitz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Calgary, Peter Lougheed Centre Vascular Clinic', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Suzanne Welsh', 'role': 'CONTACT'}, {'name': 'Robert Welsh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alberta, Mazankowski Heart Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Michelle Zondag', 'role': 'CONTACT', 'phone': '905-527-4322', 'phoneExt': '40430'}, {'name': 'Noel Chan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Teresa Novick', 'role': 'CONTACT'}, {'name': 'Adam Power, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Oakville', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Christina Machon', 'role': 'CONTACT'}, {'name': 'Beverley Chan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vascular Health Bronte', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'city': 'Scarborough Village', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Bev Bozek', 'role': 'CONTACT'}, {'name': 'Alan Joseph Ricci, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Corcare Cardiovascular Research Inc.', 'geoPoint': {'lat': 43.73899, 'lon': -79.22124}}, {'city': 'St. Catharines', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Kailee Morrison', 'role': 'CONTACT'}, {'name': 'Blair Leonard, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Niagara Health System', 'geoPoint': {'lat': 43.17126, 'lon': -79.24267}}, {'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Leslie Summers deLuca', 'role': 'CONTACT'}, {'name': 'Ahmed Kayssi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sunnybrook Research Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Guylaine Marcotte', 'role': 'CONTACT'}, {'name': 'William Fortin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CIUSSS du Nord-de-l'île-de-Montréal, Hôpital du Sacré-Cœur-de-Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G5L 3N2', 'city': 'Rimouski', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Isabelle Gagnon', 'role': 'CONTACT'}, {'name': 'François Caron, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre intégré de santé et de services sociaux du Bas-Saint-Laurent', 'geoPoint': {'lat': 48.44879, 'lon': -68.52396}}, {'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Ines Meurer', 'role': 'CONTACT'}, {'name': 'Daniel Staub, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Basel, Angiology', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Fribourg', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Sandrine Foucras', 'role': 'CONTACT'}, {'name': 'Rolf Engelberger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HFR Fribourg', 'geoPoint': {'lat': 46.80237, 'lon': 7.15128}}, {'city': 'Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Nadège Koffi', 'role': 'CONTACT'}, {'name': 'Marc Righini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpitaux Universitaires de Genève', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Rebecca Spescha', 'role': 'CONTACT'}, {'name': 'Eliane Probst', 'role': 'CONTACT'}, {'name': 'Stefano Barco, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Zurich, Clinic of Angiology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Noel C Chan, MD', 'role': 'CONTACT', 'email': 'Noel.Chan@TAARI.CA', 'phone': '905-521-2100', 'phoneExt': '40727'}, {'name': 'Jessica Tyrwhitt', 'role': 'CONTACT', 'email': 'leaderpad@phri.ca'}], 'overallOfficials': [{'name': 'Noel C Chan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Population Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Noel Chan', 'investigatorAffiliation': 'Population Health Research Institute'}}}}