Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-02-28

Brief Summary

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This study evaluates the role of colchicine in the prevention of atrial fibrillation in patients undergoing open heart surgery. Half of participants will receive colchicine and the other half will not

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Detailed Description

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Atrial fibrillation (AF) is the most common arrhythmia in patients undergoing cardiac surgery and is estimated to occur in 26% of all cardiac surgery patients. It can lead to increase morbidity, mainly due to hemodynamic instability and thromboembolic complications, and to increased hospital stay with its associated higher health care cost.

Previous studies have demonstrated that increased inflammation may precede AF and, therefore, interventions that reduce the inflammatory process may help reduce the incidence of AF. Colchicine has potent anti-inflammatory properties and may therefore be capable of reducing the incidence of AF.

This study aims to determine whether the administration of colchicine starting the day before cardiac surgery and continuing until discharge may lead to reduction in post-operative AF.

Conditions

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Arrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Colchicine

Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing \<70 kg or intolerant to the full dose.

Group Type ACTIVE_COMPARATOR

Colchicine

Intervention Type DRUG

colchicine given as per trial protocol

No colchicine

In this arm no active medication was administered

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Colchicine

colchicine given as per trial protocol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All consecutive adult patients undergoing elective cardiac surgery

Exclusion Criteria

* Documented history of AF or supraventricular arrhythmia or, absence of sinus rhythm on hospital admission
* Known severe liver disease or current transaminases \>1.5 times the upper normal limit
* Current serum creatinine \>2.5 mg/dl
* Known myopathy or elevated baseline preoperative creatine kinase
* Known blood dyscrasias
* Significant gastrointestinal disease
* Pregnant and lactating women
* Known hypersensitivity to colchicine
* Current treatment with colchicine for any indications
* Emergency surgery

Eligible Sex

ALL

Accepts Healthy Volunteers

No