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Photo for COP-AF Pilot Study

COP-AF Pilot Study

Official Title

COlchicine For Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery (COP-AF) Pilot Study

Status

Ongoing

Overview

To determine the feasibility of recruiting patients undergoing thoracic surgery to an RCT of colchicine vs. placebo for the prevention of perioperative AF. To determine the resources required to achieve recruitment, pre-operative randomization, and to conduct a full scale trial and to assess the compliance with the trial protocol

Study Design

Randomized controlled, blinded, multicenter pilot trial.

Primary Endpoint

The primary objectives of this pilot trial are to determine the feasibility of recruiting patients undergoing thoracic surgery to a randomized clinical trial (RCT) of colchicine vs. placebo for the prevention of perioperative AF, to determine the resources required to conduct a full scale trial and to assess the compliance with the trial protocol (i.e. compliance with study drug, ECG recording when necessary, and offer insight into the tolerance to perioperative colchicine). The secondary objectives are to collect preliminary data on the incidence of new onset perioperative AF or atrial flutter within the index hospitalization, death, myocardial injury after noncardiac surgery (MINS), stroke or transient ischemic attack (TIA), clinically important bradycardia, clinically important hypotension, life threatening bleeding, major bleeding, sepsis/infection, non infectious diarrhea, as well as on the duration of ICU, step-down and in-hospital stay.

Number of Patients

100

Number of Sites

2

Number of Countries

1

Study Period

2014–2015

Principal Investigator

P.J. Devereaux

Program Manager

Shirley Pettit

Research Coordinator

Barbara Jedrzejowski

Collaborators

CIHR/PSI