Colchicine to Prevent Post-Pericardiotomy Syndrome and Atrial Fibrillation

NCT02177266 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 13-008553
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The study will determine the benefit of Colchicine versus placebo for cardiac surgery patients on the post-operative development of atrial fibrillation and post-pericardiotomy syndrome. Primary Objective. Colchicine will reduce the composite endpoint of incidence of post-operative atrial fibrillation and post-pericardiotomy syndrome at 3 months following cardiac surgery. Secondary Objectives.

1. 1.Colchicine will reduce the incidence of constrictive physiology on echocardiography at 3 months following cardiac surgery.
2. 2.Reduction in the burden of symptomatic and asymptomatic atrial fibrillation in the 3 months following cardiac surgery with the use of colchicine.

Conditions

Atrial Fibrillation; Post-pericardiotomy Syndrome; Constriction

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Post Cardiac Surgery Atrial Fibrillation or Post-pericardiotomy Syndrome.

  Baseline to 3 months

Secondary Outcomes (1)

• Trans-thoracic Echocardiography for Constriction

  Baseline to 3 months

Other Outcomes (1)

• Number of Participants With Serious and Non-Serious Adverse Events

  Baseline - 3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

A placebo pill (identical to the study drug Colchicine) will be given in a double-blinded fashion to study participants randomized to placebo.

Drug: Placebo

Colchicine

EXPERIMENTAL

Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.

Drug: Colchicine

Interventions

Colchicine DRUG

Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.

Also known as: Colcrys

Colchicine

Placebo DRUG

The placebo will match the study drug.

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All consecutive adult patients (age \> 40) undergoing standard (non-minimally invasive) coronary artery bypass surgery and/or aortic valve surgery will be approached for enrollment.
• All patients must be able to provide informed consent and comply with the 3 month follow-up.
• For women of reproductive capability, contraception is necessary and required.

You may not qualify if:

• Epidermal growth factor receptor (eGFR) \< 30 mL/min/1.73 m\^2, serum creatinine \> 2.5 mg/dL or requiring dialysis
• Known permanent or current atrial fibrillation (history of paroxysmal atrial fibrillation allowed if in sinus rhythm at present)
• Allergy to colchicine or already treated with colchicine.
• Known blood dyscrasia (acute or chronic leukemia, pancytopenia, aplastic anemia, leukopenia)
• Known serious gastrointestinal disease
• Known severe liver disease (cirrhosis, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2x the upper limit of normal, Model End Stage Liver Disease (MELD) score \> 20)
• Women of childbearing potential not using contraception.
• Patients with HIV or AIDS as the use of protease inhibitors can result in serious colchicine toxicity.
• Patients who are treated with strong CYP3A4 inhibitors (clarithromycin/erythromycin, chloramphenicol, ketoconazole/itraconazole, and nefazodone).
• There is a risk of rhabdomyolysis with the use of digoxin and colchicine, we will exclude patients who require ongoing treatment with digoxin.
• Inability or unwillingness of the individual to give written informed consent.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Postpericardiotomy Syndrome; Constriction, Pathologic

Interventions

Colchicine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Limitations and Caveats

The data were not analyzed because the 2 subjects enrolled withdrew before completing the study; the study was terminated early due to the difficulty in enrolling subjects.

Results Point of Contact

• Title: Dr. Jae K. Oh
• Organization: Mayo Clinic

oh.jae@mayo.edu

507-284-6055

Study Officials

• Jae Oh, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: Professor of Medicine

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 27, 2014
• Study Start: May 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: June 21, 2017
• Results First Posted: June 21, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)