Colchicine and CRP in Atrial Fibrillation and AF Ablation

NCT01755949 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 12-001686
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; catheter ablation; colchicine; c reactive protein; CRP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Subjects With Atrial Fibrillation

  day 28

• Time Course of C-reactive Protein Levels

  baseline, day 3, day 7, day 14, day 28

Study Arms (6)

Chronic atrial fibrillation, colchicine

ACTIVE COMPARATOR

Colchicine 0.6 mg PO BID. Subjects not undergoing ablation.

Drug: Colchicine, 0.6 mg PO BID

Chronic atrial fibrillation, placebo

PLACEBO COMPARATOR

Matching placebo. Subjects not undergoing ablation.

Drug: Matching placebo

Pre-ablation, sinus rhythm, colchicine

ACTIVE COMPARATOR

Colchicine 0.6 mg PO BID. Subjects undergoing ablation.

Drug: Colchicine, 0.6 mg PO BID

Pre-ablation, sinus rhythm, placebo

PLACEBO COMPARATOR

Matching placebo. Subjects undergoing ablation.

Drug: Matching placebo

Pre-ablation, AF, colchicine

ACTIVE COMPARATOR

Colchicine 0.6 mg PO BID. Subjects undergoing ablation.

Drug: Colchicine, 0.6 mg PO BID

Pre-ablation, AF, placebo

PLACEBO COMPARATOR

Matching placebo. Subjects undergoing ablation.

Drug: Matching placebo

Interventions

Colchicine, 0.6 mg PO BID DRUG

Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo

Also known as: Colcrys

Chronic atrial fibrillation, colchicine; Pre-ablation, AF, colchicine; Pre-ablation, sinus rhythm, colchicine

Matching placebo DRUG

Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug

Also known as: placebo

Chronic atrial fibrillation, placebo; Pre-ablation, AF, placebo; Pre-ablation, sinus rhythm, placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• Abnormal liver function with elevated enzymes\> 1.5 times the normal.
• Abnormal kidney function with glomerular filtration rate \< 50 ml/min
• Increased levels of creatine kinase or known myopathy
• Neutropenia
• Known GI disorders
• 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.
• Pregnant and lactating women
• Lactose intolerance
• Known sensitivity, allergy, or contraindication to colchicine use

Sponsors & Collaborators

• Mayo Clinic: lead
• Takeda: collaborator
• Detiger Funds: collaborator

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Joseph L. Blackshear, Principal Investigator
• Organization: Mayo Clinic

blackshear.joseph@mayo.edu

904-953-7279

Study Officials

• Joseph L. Blackshear, MD

  Consultant in Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investiator

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: December 24, 2012
• Study Start: March 1, 2013
• Primary Completion: December 6, 2016
• Study Completion: December 6, 2016
• Last Updated: May 9, 2019
• Results First Posted: May 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)