COlchicine for the Prevention of Post Electrical Cardioversion Recurrence of AF

• Status: Withdrawn
• Trial end date: 2018-09-02
• Target enrollment: 0
• Participant gender: All

Summary

There is substantial evidence linking inflammation to the initiation and perpetuation of AF. Although the precise mechanism by which inflammation contributes to the development of AF remains unclear, it has been proposed that inflammation may lead to "atrial myocarditis" with subsequent electrical and structural changes involving both atrial myocytes and extracellular matrix, leading finally to initiation and maintenance of AF. The high incidence of AF in post-operative cardiac surgeries, a state of intense inflammatory process, points out this association. Similarly, in non operative AF, inflammation appears to play a prominent role in both etiology and maintenance of AF. Indeed an increase of inflammatory markers to both paroxysmal and persistent AF was shown by numerous studies.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Elpen Pharmaceutical Co. Inc.
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• patients experiencing their first episode of AF of less than 3 months duration will be given no other antiarrhythmic drugs but b-blocker

• In case of recurrent episodes of AF or if AF duration is >3 months patients on antiarrhythmic drugs of class IC or III as first choice.

• men and women

• 18 to 80 years of age

• with persistent AF (sustained for > 7 days) for which electrical cardioversion was indicated.

Exclusion Criteria:

• active inflammatory or infectious disease

• malignancy

• known autoimmune diseases

• corticosteroid or other immunosuppressive or immunomodulatory therapy

• drugs that inhibit CYP3A4 (clarithromycin, azithromycin, ketoconazole, ritonavir, verapamil, and diltiazem)

• moderate or severe hepatic impairment (Child-Pugh class B or C)

• moderate or severe renal failure (≤ 40 ml/min per 1.73 m2)

• acute coronary syndrome within a month before study enrollment

• known blood dyscrasias or gastrointestinal disease

• pregnant and lactating women

• women of childbearing potential not protected by a contraception method -

• patients with atrial flutter will be also excluded unless there is history of coexisting AF.