Colchicine and CRP in Atrial Fibrillation and AF Ablation

Atrial Fibrillation Clinical Trial

Official title:

Impact and Time Course of Colchicine Therapy on C-reactive Protein Elevation in Chronic Atrial Fibrillation (AF) and Post AF Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755949
• Other study ID #: 12-001686
• Status: Completed
• Phase: Phase 2
• Start date: March 2013
• Est. completion date: December 6, 2016

Study information

• Verified date: April 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 6, 2016
• Est. primary completion date: December 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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 .

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	Detiger Funds, Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
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.	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.	baseline, day 3, day 7, day 14, day 28

External Links

•   Mayo Clinic Clinical Trials