Effect of Low Dose ColchiciNe on the InciDence of POAF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-02

Study Completion Date

2019-05-01

Brief Summary

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The prior End-AF study by the same group showed that 1 mg of colchicine didn't decrease the incidence of AF after cardiac surgery. The current study, End-AF Low Dose Study, will test 0.5 mg colchicine vs. placebo in preventing AF after cardiac surgery.

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Detailed Description

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AF after cardiac surgery leads to excess mortality and morbidity. Colchicine was used in several studies to lower the incidence AF but the results were generally disappointing. There was no benefit in reducing AF and there was a high incidence of GI side effects especially diarrhea, often leading to stopping the medication. However, a recently published meta-analysis showed that colchicine reduced AF, but again warned of the high incidence of GI side effects. The maintenance dose of colchicine used in these studies was 1 mg daily it is hypothesized that low dose colchicine (0.5 not 1 mg colchicine) might lower AF after cardiac surgery without the prohibitive GI side effects Patients will be randomized to colchicine vs. placebo started the day before surgery and continued until hospital discharge.

The primary efficacy endpoint will be the incidence of AF. The primary safety endpoint will be the GI side effects

Conditions

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Atrial Fibrillation Cardiac Surgery Colchicine Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Colchicine

Intervention by administering an active copmarator of 1 mg colchicine one day pre op and 0.5 mg daily after surgery until discharge

Group Type ACTIVE_COMPARATOR

Colchicine

Intervention Type DRUG

Colchicine will be given to open heart surgery patients

Placebo Oral Tablet

Identical tablet (placebo) administered in a similar way as that in the active comparator arm

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo Oral Tablet will be given to open heart surgery patients according to randomization

Interventions

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Colchicine

Colchicine will be given to open heart surgery patients

Intervention Type DRUG

Placebo Oral Tablet

Placebo Oral Tablet will be given to open heart surgery patients according to randomization

Intervention Type DRUG

Other Intervention Names

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Colcrys, Mitigare Placebo

Eligibility Criteria

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Inclusion Criteria

* All patients aged 18 years or above undergoing elective cardiac surgery.
* Sinus rhythm and no previous AF
* Agreed to sign informed consent.

Exclusion Criteria

* 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 or significant gastrointestinal disease
* Pregnant and lactating women
* Known hypersensitivity to colchicine
* Current treatment with colchicine for any indications
* Emergency surgery

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No