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Colchicine for CRP in Atrial Fibrillation
NCT01755949Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2013
- Primary completion
- Dec 2016
- Countries
- 1
- Sponsor
- Mayo Clinic
- Modality
- Nucleic Acid-Directed Small Molecules, Classical Binding Small Molecules, Metabolically Activated Prodrugs
- Drugs
- colchicine
- Conditions
- Atrial fibrillation (AFib)
01
Overview
Phase 2, randomised, double-blind trial of colchicine in Atrial fibrillation (AFib) (6 arms), sponsored by Mayo Clinic. Primary endpoint: Change in C-reactive Protein at 28 days. Started Mar 2013; status: completed.
02
Design
6 arms- Study design
- RandomizedDouble-blind
Chronic AF, colchicine
Colchicine 0.6 mg PO BID. Subjects not undergoing ablation.
Chronic AF, placebo
Matching placebo. Subjects not undergoing ablation.
Pre-ablation, sinus rhythm, colchicine
Colchicine 0.6 mg PO BID. Subjects undergoing ablation.
Pre-ablation, sinus rhythm, placebo
Matching placebo. Subjects undergoing ablation.
Pre-ablation, AF, colchicine
Colchicine 0.6 mg PO BID. Subjects undergoing ablation.
Pre-ablation, AF, placebo
Matching placebo. Subjects undergoing ablation.
03
Who it enrols
Patients with paroxysmal, persistent, or chronic atrial fibrillation, including those scheduled for ablation. Excludes patients with abnormal liver or kidney function, myopathy, neutropenia, or GI disorders.
04
Endpoints
Primary
Change in C-reactive Protein
Secondary
Number of Subjects With Atrial Fibrillation
Time Course of C-reactive Protein Levels
05
Results
Not all primary endpoints met
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