The COLchicine and Atrial FIBrillation Trial

ConditionAtrial Fibrillation

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorHerlev and Gentofte Hospital

About this trial

The purpose of this study to investigate the effects of colchicine on atrial fibrillation recurrence and vascular and cardiac function in patients with atrial fibrillation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Living address in the Capital Region of Denmark

Age > 18

Diagnosed with paroxysmic/persistent AF.

Planned or acute admission for cardioversion of AF with successful outcome.

Disqualifiers

Colchicine treatment for another cause, e.g. gout

Allergy/hypersensitivity to colchicine

Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg)

History of malignancy of any organ system excluding a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, localized prostate cancer and/or localized carcinoma in situ of the cervix

Trial design

Design model

Parallel

Treatments tested in this trial

Colchicine
Drug
Colchicine 0.5 mg once daily
Placebo
Drug
Placebo once daily

Treatment groups

500 Participants

are divided into 2 treatment groups

Group A: ColchicineExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Between-group difference in change in time to first AF admission measured in days

Time frame

12 months

Secondary outcomes

Between-group difference in change in accumulated number of readmissions for symptomatic AF

Time frame

12 months

Between-group difference in change in Left Atrial Volume (LAV) assessed by echocardiography

Time frame

12 months

Between-group difference in change in Atrial Fibrillation Effect On Quality-Of-Life Questionnaire (AFEQT) score

Score of 0 being the worst outcome and score of 100 being the best outcome

Time frame

12 months

Other outcomes

Between-group difference in change in plasma concentration of high sensitivity C-Reactive Protein (hs-CRP)

Time frame

12 months

Between-group difference in change in plasma concentration of high sensitivity Troponin I (hs-TnI)

Time frame

12 months

Between-group difference in change in Left Ventricle (LV) septal wall thickness assessed by echocardiography

Time frame

12 months

Between-group difference in change in LV mass index assessed by echocardiography

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Herlev and Gentofte Hospital

Lead sponsor

Source ClinicalTrials.gov

Apply now