Colchicine and CRP in Atrial Fibrillation and AF Ablation
NCT ID: NCT01755949
Last Updated: 2019-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2013-03-31
2016-12-06
Brief Summary
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Detailed Description
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1. Paroxysmal atrial fibrillation, pre-ablation
2. Persistent atrial fibrillation, pre-ablation
3. Chronic persistent atrial fibrillation
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Chronic atrial fibrillation, colchicine
Colchicine 0.6 mg PO BID. Subjects not undergoing ablation.
Colchicine, 0.6 mg PO BID
Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo
Chronic atrial fibrillation, placebo
Matching placebo. Subjects not undergoing ablation.
Matching placebo
Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug
Pre-ablation, sinus rhythm, colchicine
Colchicine 0.6 mg PO BID. Subjects undergoing ablation.
Colchicine, 0.6 mg PO BID
Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo
Pre-ablation, sinus rhythm, placebo
Matching placebo. Subjects undergoing ablation.
Matching placebo
Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug
Pre-ablation, AF, colchicine
Colchicine 0.6 mg PO BID. Subjects undergoing ablation.
Colchicine, 0.6 mg PO BID
Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo
Pre-ablation, AF, placebo
Matching placebo. Subjects undergoing ablation.
Matching placebo
Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug
Interventions
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Colchicine, 0.6 mg PO BID
Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo
Matching placebo
Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 .
Exclusion Criteria
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
21 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Detiger Funds
UNKNOWN
Mayo Clinic
OTHER
Responsible Party
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Joseph L. Blackshear
Principal Investiator
Principal Investigators
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Joseph L. Blackshear, MD
Role: PRINCIPAL_INVESTIGATOR
Consultant in Cardiovascular Diseases
Locations
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Mayo Clinic Florida
Jacksonville, Florida, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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12-001686
Identifier Type: -
Identifier Source: org_study_id
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