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

A Mechanistic Clinical Trial of Colchicine in Patients Undergoing Femoral Endarterectomy

Early Phase 1

Recruiting

Conditions: Peripheral Artery Disease

Interventions: Drug: Colchicine
Drug: Placebo

First Posted Date: 2024-01-18

Last Posted Date: 2024-10-02

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 24

Registration Number: NCT06212271

Locations: 🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States

Inflammation REduction to Prevent CArdiovascular Injury in Renal Disease (REPAIR)

Phase 1

Recruiting

Conditions: Renal Failure
Chronic Kidney Diseases

Interventions: Drug: Colchicine

First Posted Date: 2024-01-12

Last Posted Date: 2025-03-12

Lead Sponsor: Hamilton Health Sciences Corporation

Target Recruit Count: 200

Registration Number: NCT06203977

Locations: 🇨🇦
University of Alberta Hospital, Edmonton, Alberta, Canada
🇨🇦
St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada
🇨🇦
London Health Sciences Centre, London, Ontario, Canada

CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine

Phase 3

Recruiting

Conditions: Cardiomyopathies
Myocarditis
Inflammatory Cardiomyopathy
Heart Failure
Ventricular Arrythmia

Interventions: Other: Placebo
Drug: Colchicine

First Posted Date: 2023-12-06

Last Posted Date: 2024-12-13

Lead Sponsor: Niguarda Hospital

Target Recruit Count: 80

Registration Number: NCT06158698

Locations: 🇮🇹
Policlinico S.Orsola-Malpighi, Bologna, Emilia Romagna, Italy
🇮🇹
Università degli studi della Campania L.Vanvitelli e Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi, Napoli, Campania, Italy
🇮🇹
Azienda Sanitaria Universitaria Integrata Giuliano Isontina, Trieste, Trieste, Friuli-Venezia Giulia, Italy

and more 7 locations

Withdrawal of Colchicine in Behçet Syndrome

Not yet recruiting

Conditions: Behçet's Syndrome

Interventions: Drug: Colchicine

First Posted Date: 2023-11-24

Last Posted Date: 2023-11-24

Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Target Recruit Count: 130

Registration Number: NCT06146192

Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammation

Phase 2

Recruiting

Conditions: Heart Failure
Inflammation

Interventions: Drug: Low Dose Colchicine
Drug: Placebo

First Posted Date: 2023-11-13

Last Posted Date: 2025-04-25

Lead Sponsor: University of Texas Southwestern Medical Center

Target Recruit Count: 60

Registration Number: NCT06130059

Locations: 🇺🇸
UT Southwestern Medical Center, Dallas, Texas, United States

Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery

Phase 3

Recruiting

Conditions: Inflammatory Response
Cardiac Disease

Interventions: Drug: Colchicine 0.5 MG
Drug: Placebo

First Posted Date: 2023-11-07

Last Posted Date: 2025-01-29

Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Target Recruit Count: 768

Registration Number: NCT06118034

Locations: 🇨🇳
Dong-Jin Wang, Nanjing, Jiangsu, China

Efficacy of Colchicine in Preventing Recurrent Stroke in the Patients With Acute Atherothrombotic Ischemic Stroke During Hospitalization

Phase 4

Recruiting

Conditions: Ischemic Stroke

Interventions: Drug: Colchicine
Drug: Clopidogrel

First Posted Date: 2023-10-26

Last Posted Date: 2023-11-07

Lead Sponsor: Mikhail Zykov

Target Recruit Count: 200

Registration Number: NCT06102720

Locations: 🇷🇺
Sochi City Hospital #4, Sochi, Krasnodar Refion, Russian Federation
🇷🇺
Research Institute for Complex Issues of Cardiovascular Diseas, Kemerovo, Kemerovo Region, Russian Federation

Colchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention

Phase 3

Recruiting

Conditions: Coronary Artery Disease

Interventions: Drug: Colchicine 0.5 MG Oral Tablet
Drug: Placebo

First Posted Date: 2023-10-23

Last Posted Date: 2024-03-08

Lead Sponsor: AZ Sint-Jan AV

Target Recruit Count: 2770

Registration Number: NCT06095765

Locations: 🇧🇪
Het Ziekenhuisnetwerk Antwerpen, Antwerpen, Belgium
🇧🇪
Universitair Ziekenhuis Antwerpen, Antwerpen, Belgium
🇧🇪
AZ Sint-Lucas & Volkskliniek, Gent, Belgium

and more 16 locations

Anti-inflammatory Therapy for Recurrent In-stent Restenosis

Phase 4

Not yet recruiting

Conditions: In-stent Restenosis

Interventions: Drug: Aspirin
Drug: Colchicine
Drug: Prednisone
Drug: P2Y12 Receptor Antagonist
Drug: Lipid-lowering drug

First Posted Date: 2023-10-19

Last Posted Date: 2023-10-19

Lead Sponsor: Fu Wai Hospital, Beijing, China

Target Recruit Count: 252

Registration Number: NCT06090890

Locations: 🇨🇳
Beijing Anzhen Hospital, Capital Medical University, Beijing, Beijing, China
🇨🇳
Beijing Friendship Hospital, Beijing, Beijing, China
🇨🇳
Beijing Luhe Hospital, Beijing, Beijing, China

and more 1 locations

Different Doses of Colchicine on hsCRP

Phase 4

Completed

Conditions: Coronary Artery Disease
Percutaneous Coronary Intervention

Interventions: Drug: Colchicine 0.5 MG
Drug: Colchicine 0.375 MG
Drug: Colchicine 0.25 MG
Drug: Placebo

First Posted Date: 2023-10-12

Last Posted Date: 2024-04-16

Lead Sponsor: Wuhan Union Hospital, China

Target Recruit Count: 200

Registration Number: NCT06078904

Locations: 🇨🇳
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

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