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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
| Detiger Funds | UNKNOWN |
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Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the rise in CRP which occurs following atrial fibrillation ablation
Three groups of patients will be randomized to colchicine 0.6 mg PO bis in die (BID) or matching placebo:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic atrial fibrillation, colchicine | Active Comparator | Colchicine 0.6 mg PO BID. Subjects not undergoing ablation. |
|
| Chronic atrial fibrillation, placebo | Placebo Comparator | Matching placebo. Subjects not undergoing ablation. |
|
| Pre-ablation, sinus rhythm, colchicine | Active Comparator | Colchicine 0.6 mg PO BID. Subjects undergoing ablation. |
|
| Pre-ablation, sinus rhythm, placebo | Placebo Comparator | Matching placebo. Subjects undergoing ablation. |
|
| Pre-ablation, AF, colchicine | Active Comparator | Colchicine 0.6 mg PO BID. Subjects undergoing ablation. |
|
| Pre-ablation, AF, placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine, 0.6 mg PO BID | Drug | Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in C-reactive Protein | Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay. | baseline, day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Atrial Fibrillation | All subjects will have 12 lead ECG on day 28 to measure the number of subjects with normal sinus rhythm and atrial fibrillation. | day 28 |
| Time Course of C-reactive Protein Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph L. Blackshear, MD | Consultant in Cardiovascular Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chronic Atrial Fibrillation, 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 not undergoing ablation. |
| BG001 | Chronic Atrial Fibrillation, Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in C-reactive Protein | Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay. | 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. | Posted | Mean | Standard Deviation | ng/mL | baseline, day 28 |
|
28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chronic Atrial Fibrillation, 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 not undergoing ablation. |
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Enrollment was halted in 2015 due to departure of study staff; shortly thereafter Takeda Inc announced it could not renew production of colchicine nor support the study after the end of 2016. Principal investigator elected to terminate enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph L. Blackshear, Principal Investigator | Mayo Clinic | 904-953-7279 | blackshear.joseph@mayo.edu |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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Matching placebo. Subjects undergoing ablation.
|
|
| Matching placebo | Drug | Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug |
|
|
Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay.
| baseline, day 3, day 7, day 14, day 28 |
Matching placebo Matching placebo: Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug Subjects not undergoing ablation. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Pre-ablation, Sinus Rhythm, Colchicine | Colchicine 0.6 mg, twice daily for 28 days Subjects undergoing ablation. |
| OG003 | Pre-ablation, Sinus Rhythm, Placebo | Placebo tablets, encapsulated to be indistinguishable from active drug, twice daily for 28 days Subjects undergoing ablation. |
| OG004 | Pre-ablation, AF, Colchicine | Colchicine 0.6 mg, twice daily for 28 days Subjects undergoing ablation. |
| OG005 | Pre-ablation, AF, Placebo | Placebo tablets, encapsulated to be indistinguishable from active drug, twice daily for 28 days Subjects undergoing ablation. |
|
|
|
| Secondary | Number of Subjects With Atrial Fibrillation | All subjects will have 12 lead ECG on day 28 to measure the number of subjects with normal sinus rhythm and atrial fibrillation. | Posted | Count of Participants | Participants | day 28 |
|
|
|
|
| Secondary | Time Course of C-reactive Protein Levels | Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay. | 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. | Posted | Mean | Standard Deviation | ng/ml | baseline, day 3, day 7, day 14, day 28 |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG003 | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG004 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG005 | 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. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
|
| Atrial fibrillation |
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| Day 3 |
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| Day 7 |
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| Day 14 |
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| Day 28 |
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