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COlchicine for the Prevention of Post Electrical Cardioversion Recurrence of AF

NCT02582190 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2018-01-25

No results posted yet for this study

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

Interventions

DRUG

Colchicine group

antiarrhythmic therapy plus colchicine \& antiarrhythmic therapy alone.

Sponsors & Collaborators

  • Elpen Pharmaceutical Co. Inc.

    lead INDUSTRY

Principal Investigators

  • Nikolaos Fragakis, MD · Hippokrateion hospital of Thessaloniki

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-02
Primary Completion
2018-09-02
Completion
2018-09-02

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02582190 on ClinicalTrials.gov