Colchicine and CRP in Atrial Fibrillation and AF Ablation

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: Colchicine, 0.6 mg PO BID; Drug: Matching placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01755949

12-001686

Details and patient eligibility

About

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

Full 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

Enrollment: 26 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

26 participants in 6 patient groups, including a placebo group

Chronic atrial fibrillation, colchicine

Active Comparator group

Description:

Colchicine 0.6 mg PO BID. Subjects not undergoing ablation.

Treatment:

Drug: Colchicine, 0.6 mg PO BID

Chronic atrial fibrillation, placebo

Placebo Comparator group

Description:

Matching placebo. Subjects not undergoing ablation.

Treatment:

Drug: Matching placebo

Pre-ablation, sinus rhythm, colchicine

Active Comparator group

Description:

Colchicine 0.6 mg PO BID. Subjects undergoing ablation.

Treatment:

Drug: Colchicine, 0.6 mg PO BID

Pre-ablation, sinus rhythm, placebo

Placebo Comparator group

Description:

Matching placebo. Subjects undergoing ablation.

Treatment:

Drug: Matching placebo

Pre-ablation, AF, colchicine

Active Comparator group

Description:

Colchicine 0.6 mg PO BID. Subjects undergoing ablation.

Treatment:

Drug: Colchicine, 0.6 mg PO BID

Pre-ablation, AF, placebo

Placebo Comparator group

Description:

Matching placebo. Subjects undergoing ablation.

Treatment:

Drug: Matching placebo