Colchicine and CRP in Atrial Fibrillation and AF Ablation

Phase 2

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Colchicine, 0.6 mg PO BID; Drug: Matching placebo

• Registration Number: NCT01755949
• Lead Sponsor: Mayo Clinic

Brief Summary

Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the rise in CRP which occurs following atrial fibrillation ablation

Detailed Description

Three groups of patients will be randomized to colchicine 0.6 mg PO bis in die (BID) or matching placebo:

1. Paroxysmal atrial fibrillation, pre-ablation

2. Persistent atrial fibrillation, pre-ablation

3. Chronic persistent atrial fibrillation

Study Timeline

• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-24
• Study Start: 2013-03
• Primary Completion: 2016-12-06
• Study Completion: 2016-12-06
• Results First Submitted: 2018-01-12
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-18
• Last Update Submitted: 2019-04-18
• Results First Posted: 2019-05-09
• Last Update Posted: 2019-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Group 1: Persistent or chronic AF presenting for evaluation in cardiology offices. Diagnosis of AF will be made based on the 12 -lead surface ECG.
• Group 2: Paroxysmal AF scheduled to go AF ablation presenting to the electrophysiology laboratory for the procedure in sinus rhythm..
• Group 3:Chronic AF scheduled to go clinically indicated AF ablation, and presenting in the electrophysiology laboratory in atrial fibrillation .

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Exclusion Criteria

1. Abnormal liver function with elevated enzymes> 1.5 times the normal.
2. Abnormal kidney function with glomerular filtration rate < 50 ml/min
3. Increased levels of creatine kinase or known myopathy
4. Neutropenia
5. Known GI disorders
6. Women of childbearing age who have not had surgical sterilization and are not using oral contraceptives, or who's spouse has not had surgical sterilization will be excluded due to the length of the trial and the possibility that they could become pregnant after entry.
7. Pregnant and lactating women
8. Lactose intolerance
9. Known sensitivity, allergy, or contraindication to colchicine use

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chronic atrial fibrillation, colchicine	Colchicine, 0.6 mg PO BID	Colchicine 0.6 mg PO BID. Subjects not undergoing ablation.
Pre-ablation, sinus rhythm, placebo	Matching placebo	Matching placebo. Subjects undergoing ablation.
Pre-ablation, AF, colchicine	Colchicine, 0.6 mg PO BID	Colchicine 0.6 mg PO BID. Subjects undergoing ablation.
Chronic atrial fibrillation, placebo	Matching placebo	Matching placebo. Subjects not undergoing ablation.
Pre-ablation, sinus rhythm, colchicine	Colchicine, 0.6 mg PO BID	Colchicine 0.6 mg PO BID. Subjects undergoing ablation.
Pre-ablation, AF, placebo	Matching placebo	Matching placebo. Subjects undergoing ablation.

Primary Outcome Measures

Name	Time	Method
Change in C-reactive Protein	baseline, day 28	Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Atrial Fibrillation	day 28	All subjects will have 12 lead ECG on day 28 to measure the number of subjects with normal sinus rhythm and atrial fibrillation.
Time Course of C-reactive Protein Levels	baseline, day 3, day 7, day 14, day 28	Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay.

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States