COlchicine for the Prevention of Post Electrical Cardioversion Recurrence of AF

NCT02582190 | Withdrawn Phase 3

• 1 other identifier: 2015-IIS-GR-COL
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atrial Fibrillation

Keywords

electrical cardioversion; persistent atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of patients with AF recurrence

  Change in AF recurrence from baseline to 180 days

  180 days

Secondary Outcomes (1)

• Number of adverse events

  180 days

Study Arms (1)

Colchicine group

OTHER

Colchicine add on therapy in atrial fibrillation

Drug: Colchicine group

Interventions

Colchicine group DRUG

antiarrhythmic therapy plus colchicine \& antiarrhythmic therapy alone.

Also known as: Colchicine in atrial fibrillation

Colchicine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• to 80 years of age
• with persistent AF (sustained for \> 7 days) for which electrical cardioversion was indicated.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Related Publications (36)

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MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Nikolaos Fragakis, MD

  Hippokrateion hospital of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2015
• First Posted: October 21, 2015
• Study Start: December 2, 2017
• Primary Completion: September 2, 2018
• Study Completion: September 2, 2018
• Last Updated: January 25, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share