Trial Outcomes & Findings for Colchicine and CRP in Atrial Fibrillation and AF Ablation (NCT NCT01755949)

Last Updated: 2019-05-09

Results Overview

Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

baseline, day 28

Results posted on

2019-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Chronic Atrial Fibrillation, Colchicine Colchicine 0.6 mg PO bis in die (BID) Colchicine, 0.6 mg PO BID: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo Subjects not undergoing ablation.	Chronic Atrial Fibrillation, Placebo Matching placebo Matching placebo: Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug Subjects not undergoing ablation.	Pre-ablation, Sinus Rhythm, Colchicine Colchicine 0.6 mg PO BID Colchicine, 0.6 mg PO BID: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo Subjects undergoing ablation.	Pre-ablation, Sinus Rhythm, Placebo Matching placebo Matching placebo: Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug Subjects undergoing ablation.	Pre-ablation, AF, Colchicine Colchicine 0.6 mg PO BID Colchicine, 0.6 mg PO BID: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo Subjects undergoing ablation.	Pre-ablation, AF, Placebo Matching placebo Matching placebo: Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug Subjects undergoing ablation.
Overall Study STARTED	5	5	4	5	4	3
Overall Study COMPLETED	5	5	4	5	4	3
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Colchicine and CRP in Atrial Fibrillation and AF Ablation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chronic Atrial Fibrillation, Colchicine n=5 Participants Colchicine 0.6 mg PO BID Colchicine, 0.6 mg PO BID: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo Subjects not undergoing ablation.	Chronic Atrial Fibrillation, Placebo n=5 Participants Matching placebo Matching placebo: Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug Subjects not undergoing ablation.	Pre-ablation, Sinus Rhythm, Colchicine n=4 Participants Colchicine 0.6 mg PO BID Colchicine, 0.6 mg PO BID: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo Subjects undergoing ablation.	Pre-ablation, Sinus Rhythm, Placebo n=5 Participants Matching placebo Matching placebo: Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug Subjects undergoing ablation.	Pre-ablation, AF, Colchicine n=4 Participants Colchicine 0.6 mg PO BID Colchicine, 0.6 mg PO BID: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo Subjects undergoing ablation.	Pre-ablation, AF, Placebo n=3 Participants Matching placebo Matching placebo: Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug Subjects undergoing ablation.	Total n=26 Participants Total of all reporting groups
Age, Continuous	71 years STANDARD_DEVIATION 7 • n=5 Participants	73 years STANDARD_DEVIATION 8 • n=7 Participants	65 years STANDARD_DEVIATION 5 • n=5 Participants	69 years STANDARD_DEVIATION 6 • n=4 Participants	68 years STANDARD_DEVIATION 7 • n=21 Participants	62 years STANDARD_DEVIATION 18 • n=8 Participants	68 years STANDARD_DEVIATION 8.5 • n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	22 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	25 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Region of Enrollment United States	5 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	26 Participants n=8 Participants

PRIMARY outcome

Timeframe: baseline, day 28

Population: Not all subjects had sample available at all timepoints to measure C-reactive protein levels. Sample was either not collected or insufficient volume to run assay.

Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay.

Outcome measures

Outcome measures
Measure	Chronic Atrial Fibrillation, Colchicine n=5 Participants Colchicine 0.6 mg, twice daily for 28 days Subjects not undergoing ablation.	Chronic Atrial Fibrillation, Placebo n=5 Participants Placebo tablets, encapsulated to be indistinguishable from active drug, twice daily for 28 days Subjects not undergoing ablation.	Pre-ablation, Sinus Rhythm, Colchicine n=4 Participants Colchicine 0.6 mg, twice daily for 28 days Subjects undergoing ablation.	Pre-ablation, Sinus Rhythm, Placebo n=5 Participants Placebo tablets, encapsulated to be indistinguishable from active drug, twice daily for 28 days Subjects undergoing ablation.	Pre-ablation, AF, Colchicine n=3 Participants Colchicine 0.6 mg, twice daily for 28 days Subjects undergoing ablation.	Pre-ablation, AF, Placebo n=3 Participants Placebo tablets, encapsulated to be indistinguishable from active drug, twice daily for 28 days Subjects undergoing ablation.
Change in C-reactive Protein Baseline	6.4 ng/mL Standard Deviation 7.2	2.7 ng/mL Standard Deviation 2.9	2.9 ng/mL Standard Deviation 1.6	5.9 ng/mL Standard Deviation 5.5	2.6 ng/mL Standard Deviation 2.7	2.3 ng/mL Standard Deviation 1.7
Change in C-reactive Protein day 28	1.8 ng/mL Standard Deviation 2.0	2.7 ng/mL Standard Deviation 1.4	1.0 ng/mL Standard Deviation 0.7	2.5 ng/mL Standard Deviation 1.7	1.2 ng/mL Standard Deviation 1.0	5.2 ng/mL Standard Deviation 5.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Chronic Atrial Fibrillation, Colchicine n=5 Participants Colchicine 0.6 mg, twice daily for 28 days Subjects not undergoing ablation.	Chronic Atrial Fibrillation, Placebo n=5 Participants Placebo tablets, encapsulated to be indistinguishable from active drug, twice daily for 28 days Subjects not undergoing ablation.	Pre-ablation, Sinus Rhythm, Colchicine n=4 Participants Colchicine 0.6 mg, twice daily for 28 days Subjects undergoing ablation.	Pre-ablation, Sinus Rhythm, Placebo n=4 Participants Placebo tablets, encapsulated to be indistinguishable from active drug, twice daily for 28 days Subjects undergoing ablation.	Pre-ablation, AF, Colchicine n=4 Participants Colchicine 0.6 mg, twice daily for 28 days Subjects undergoing ablation.	Pre-ablation, AF, Placebo n=3 Participants Placebo tablets, encapsulated to be indistinguishable from active drug, twice daily for 28 days Subjects undergoing ablation.
Number of Subjects With Atrial Fibrillation Sinus rhythm	5 Participants	1 Participants	4 Participants	3 Participants	4 Participants	1 Participants
Number of Subjects With Atrial Fibrillation Atrial fibrillation	0 Participants	4 Participants	0 Participants	1 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: baseline, day 3, day 7, day 14, day 28

Population: Not all subjects had sample available at all timepoints to measure C-reactive protein levels. Sample was either not collected or insufficient volume to run assay.

Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay.