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Colchicine For Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery Pilot Study

Information source: McMaster University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation; Thoracic Surgery

Intervention: Colchicine (Drug); Colchicine Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: McMaster University

Official(s) and/or principal investigator(s):
PJ Devereaux, PhD, Principal Investigator, Affiliation: McMaster University

Summary

The purpose of this pilot study is to determine the feasibility of comparing colchicine to placebo for the prevention of new onset atrial fibrillation in patients undergoing general thoracic surgery and establish the foundation for a large, multi-centre, clinical trial.

Clinical Details

Official title: Colchicine For Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery Pilot Study.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Clinically Significant Atrial Fibrillation

Secondary outcome:

Death

New onset atrial flutter

Myocardial Injury After Non-Cardiac Surgery (MINS)

Stroke

Transient Ischemic Attack (TIA)

Post-operative infection

Eligibility

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- All patients ≥55 years of age undergoing intra-thoracic surgery for a resection of

tumor in lung. Exclusion Criteria:

- In AF prior to surgery*,

- Undergoing minor thoracic interventions/ procedures (i. e., chest tube insertion,

needle pleural/lung biopsies, or minor chest-wall surgeries), or

- With contraindications to colchicine (i. e., allergy, or myelodysplastic disorders or

estimated glomerular filtration rate [e-GFR] <30 mL/min/1. 73m)

- Clarification: Patients with history of AF who are in sinus rhythm during

enrollment will be eligible for recruitment. Patients who have no history of AF and are found to be in AF at the time of enrollment will not be eligible.

Locations and Contacts

University of Manitoba Health Sciences Centre, Winnipeg, Manitoba R3A 1R9, Canada

St. Joseph Healthcare, St. Joseph Hospital, Hamilton, Ontario L8N 4A6, Canada

Additional Information

Starting date: April 2014
Last updated: July 10, 2015

Page last updated: August 20, 2015

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