NCT02282098

Brief Summary

The purpose of this study is to determine the feasibility of performing a randomized controlled trial to investigate the efficacy of an anti-inflammatory drug, colchicine, at reducing well validated markers of thrombosis (D-dimer) and inflammation (hs-CRP).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3 atrial-fibrillation

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_3 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2020

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

6 years

First QC Date

October 29, 2014

Last Update Submit

February 19, 2021

Conditions

Atrial FibrillationStroke

Keywords

Atrial fibrillationArrhythmias, CardiacStrokeagents, anti inflammatoryD-dimerC-reactive protein

Outcome Measures

Primary Outcomes (2)

  • Recruitment rates

    Number of eligible patients successfully randomized into study per year of study.

    Randomization to Month 3

  • Drop-out rates

    Proportion of participants withdrawing from study for any reason

    Randomization to Month 3

Secondary Outcomes (4)

  • D-dimer

    Randomization to Month 3

  • hs-CRP

    Randomization to Month 3

  • Proportion of patients with a clinically significant adverse event

    Randomization to Month 3

  • Drug adherence

    Randomization to Month 3

Study Arms (2)

Active Colchicine

EXPERIMENTAL

The intervention group will receive colchicine 0.6 mg twice daily orally for 3 months

Drug: Colchicine

Placebo Colchicine

PLACEBO COMPARATOR

The control group will receive colchicine placebo 0.6mg twice daily orally for 3 months.

Drug: Placebo

Interventions

ColchicineDRUG

Colchicine 0.6mg twice daily

Also known as: pms-Colchicine
Active Colchicine
PlaceboDRUG

Placebo Colchicine

Also known as: Placebo Capsule
Placebo Colchicine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with atrial fibrillation who has been receiving chronic anticoagulation for at least 3 months.

You may not qualify if:

  • Contraindications to colchicine such as allergy/hypersensitivity,
  • Receiving colchicine or other anti-inflammatory drugs (such as corticosteroids, methotrexate, anti-neoplastic, Interleukin 1-1b antagonist, Tumor necrosis factor-alpha inhibitor),
  • Receiving food or co-medications such as strong-moderate cytochrome P450 3A4 inhibitors that will result in elevated plasma level of colchicine,
  • Inflammatory disorders (SLE, Rheumatoid arthritis, connective tissue disorder) or chronic infection,
  • Severe renal (eGFR\< 30ml/min/1.73m2), or liver failure or liver aminotransferase (ALT/AST \> 2x Upper limit of normal),
  • Moderate or severe cytopenias (platelet \< 100, neutrophil count \< 1.5) or existing blood dyscrasia (e.g., myelodysplasia)
  • Pregnant or lactating woman or woman of child bearing age no protected by reliable contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Atrial FibrillationStrokeArrhythmias, Cardiac

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Noel Chan, MD

    Population Health Research Institute

    PRINCIPAL INVESTIGATOR

  • John Eikelboom, MD

    Population Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

October 29, 2014

First Posted

November 4, 2014

Study Start

November 1, 2014

Primary Completion

November 17, 2020

Study Completion

November 17, 2020

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations

CA(1)