Colchicine

Generic Name: Colchicine

Brand Names: Colcrys, Gloperba, Lodoco, Mitigare

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₅NO_₆

CAS Number: 64-86-8

Unique Ingredient Identifier: SML2Y3J35T

Advanced Drug Monograph

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Background: Colchicine is an alkaloid drug derived from a plant belonging to the Lily family, known as Colchicum autumnale, or "autumn crocus." Its use was first approved by the FDA in 1961. Colchicine is used in the treatment of gout flares and Familial Mediterranean fever, and prevention of major cardiovascular events. It has also been investigated in other inflammatory and fibrotic conditions.

Indication: Colchicine is indicated for the prophylaxis and treatment of gout flares. It is also indicated in Familial Mediterranean fever (FMF) in children and adults of four years of age and older. It is also indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

Some off-label uses of colchicine include the treatment of the manifestations of Behcet's syndrome, pericarditis, and postpericardiotomy syndrome.

Associated Conditions: Behcet's Syndrome, Cardiovascular Mortality, Coronary Revascularization, Familial Mediterranean Fever (FMF ), Gout Flares, Myocardial Infarction, Pericarditis, Postpericardiotomy Syndrome, Stroke

Clinical Trials

Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke

Phase 4

Not yet recruiting

Conditions: Ischemic Stroke

Interventions: Drug: Rivaroxaban 2.5 Mg Oral Tablet
Drug: Placebo Rivaroxaban
Drug: Placebo Colchicine
Drug: Colchicine 0.5 MG

First Posted Date: 2024-05-02

Last Posted Date: 2025-05-21

Lead Sponsor: Brazilian Clinical Research Institute

Target Recruit Count: 4500

Registration Number: NCT06396858

ACT-GLOBAL Adaptive Platform Trial for Stroke

Phase 3

Recruiting

Conditions: Stroke

Interventions: Drug: Standard-dose intravenous tenecteplase
Other: Conservative Blood Pressure Control
Other: Placebo
Other: No deferoxamine mesylate and no colchicine
Drug: Deferoxamine mesylate only
Drug: Low-dose intravenous tenecteplase
Other: Moderate Blood Pressure Control
Drug: NoNO-42
Drug: Colchicine only
Other: No intravenous tenecteplase
Other: Intensive Blood Pressure Control
Drug: Both deferoxamine mesylate and colchicine

First Posted Date: 2024-04-08

Last Posted Date: 2024-11-21

Lead Sponsor: The George Institute

Target Recruit Count: 20000

Registration Number: NCT06352632

Locations: 🇦🇺
The George Institute for Global Health, Sydney, New South Wales, Australia
🇨🇦
University of Calgary, Calgary, Alberta, Canada

Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Coronary Artery Disease

Phase 4

Completed

Conditions: Coronary Artery Disease

Interventions: Drug: Colchicine 0.5 MG

First Posted Date: 2024-04-02

Last Posted Date: 2024-10-14

Lead Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Target Recruit Count: 84

Registration Number: NCT06342609

Locations: 🇺🇸
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center, Torrance, California, United States

Colchicine Versus Beta-blockers, Angiotensin-converting Enzyme Inhibitors, and Statins for Prevention of Chemotherapy-Induced Cardiomyopathy

Phase 1

Not yet recruiting

Conditions: Chemotherapy Induced Systolic Dysfunction

Interventions: Drug: Placebo
Drug: Carvedilol
Drug: Colchicine
Drug: Ramipril
Drug: Rosuvastatin

First Posted Date: 2024-03-12

Last Posted Date: 2024-03-12

Lead Sponsor: Arab Contractors Medical Centre

Target Recruit Count: 150

Registration Number: NCT06304896

Locations: 🇪🇬
Arab Contractors Medical Centre, Cairo, Egypt

Colchicine in Acutely Decompensated HFREF

Phase 4

Recruiting

Conditions: Heart Failure
Heart Failure With Reduced Ejection Fraction
Decompensated Heart Failure

Interventions: Drug: Control/Placebo group
Drug: Colchicine 0.6 mg

First Posted Date: 2024-02-29

Last Posted Date: 2024-05-08

Lead Sponsor: University of Virginia

Target Recruit Count: 30

Registration Number: NCT06286423

Locations: 🇺🇸
UVA Health, Charlottesville, Virginia, United States

Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)

Phase 4

Withdrawn

Conditions: Atherosclerosis
Coronary Artery Disease
Heart Attack

Interventions: Drug: Statin
Drug: Aspirin tablet
Drug: Nexlizet
Drug: LEQVIO
Drug: Vascepa
Drug: Jardiance
Drug: Colchicine

First Posted Date: 2024-02-28

Last Posted Date: 2025-03-17

Lead Sponsor: University of Louisville

Target Recruit Count: 200

Registration Number: NCT06280976

Locations: 🇺🇸
University of Louisville School of Medicine, Division of Cardiovascular Diseases, Louisville, Kentucky, United States

Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery

Phase 3

Recruiting

Conditions: Cardiovascular Diseases
Cardiovascular Complication
Perioperative Complication
Myocardial Injury
Myocardial Injury After Noncardiac Surgery (MINS)

Interventions: Drug: Colchicine
Drug: Placebo

First Posted Date: 2024-02-26

Last Posted Date: 2025-04-24

Lead Sponsor: Cantonal Hospital of St. Gallen

Target Recruit Count: 880

Registration Number: NCT06279000

Locations: 🇨🇭
Cantonal Hospital St. Gallen, St. Gallen, Switzerland

A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment.

Phase 2

Active, not recruiting

Conditions: Gout Arthritis

Interventions: Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg
Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg
Drug: Colchicine 0.5 mg

First Posted Date: 2024-02-21

Last Posted Date: 2024-08-05

Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Target Recruit Count: 157

Registration Number: NCT06270225

Locations: 🇨🇳
Shanghai Huashan Hospital Fudan University-Rheumatology, Shanghai, Shanghai, China

Treatment of ACuTe Coronary Syndromes With Low-dose colchICine

Not Applicable

Recruiting

Conditions: ST Elevation Myocardial Infarction
Acute Coronary Syndrome
Colchicine
Unstable Angina
Non ST Segment Elevation Myocardial Infarction

Interventions: Drug: Colchicine Pill
Drug: Placebo

First Posted Date: 2024-01-22

Last Posted Date: 2024-10-30

Lead Sponsor: Beijing Anzhen Hospital

Target Recruit Count: 6574

Registration Number: NCT06215989

Locations: 🇨🇳
Beijing Anzhen Hospital, Beijing, Beijing, China

Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction

Phase 2

Not yet recruiting

Conditions: Microvascular Coronary Artery Disease
Heart Failure With Preserved Ejection Fraction

Interventions: Drug: Colchicine
Drug: Placebo

First Posted Date: 2024-01-22

Last Posted Date: 2024-01-25

Lead Sponsor: Montreal Heart Institute

Target Recruit Count: 60

Registration Number: NCT06217120

Locations: 🇨🇦
Montreal Heart Institute, Montréal, Quebec, Canada

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