Atrial Fibrillation Clinical Trial
Official title:
Colchicine Versus Placebo in Post-Cardiac Surgery Patients to Prevent Post-Pericardiotomy Syndrome and Atrial Fibrillation
NCT number | NCT02177266 |
Other study ID # | 13-008553 |
Secondary ID | |
Status | Not yet recruiting |
Phase | Phase 3 |
First received | June 18, 2014 |
Last updated | June 25, 2014 |
Start date | June 2014 |
Verified date | June 2014 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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. Colchicine will reduce the incidence of constrictive physiology on echocardiography at
3 months following cardiac surgery.
2. Reduction in the burden of symptomatic and asymptomatic atrial fibrillation in the 3
months following cardiac surgery with the use of colchicine.
Status | Not yet recruiting |
Enrollment | 242 |
Est. completion date | |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria The study population will consist participants enrolled at the Mayo
Clinic, Rochester Minnesota. - 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. Exclusion Criteria All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation: - eGFR < 30 mL/min/1.73 m2, 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, AST/ALT > 2x the upper limit of normal, 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/erythyromycin, 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants with Serious and Non-Serious Adverse Events | Baseline - 3 months | Yes | |
Primary | Number of patients with post cardiac surgery atrial fibrillation or post-pericardiotomy syndrome. | Baseline to 3 months | No | |
Secondary | Trans-thoracic echocardiography for constriction | Baseline to 3 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Completed |
NCT04571385 -
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
|
Phase 2 | |
Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
Completed |
NCT05366803 -
Women's Health Initiative Silent Atrial Fibrillation Recording Study
|
N/A | |
Completed |
NCT02864758 -
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
|
||
Recruiting |
NCT05442203 -
Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
|
N/A | |
Completed |
NCT05599308 -
Evaluation of Blood Pressure Monitor With AFib Screening Feature
|
N/A | |
Completed |
NCT03790917 -
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
|
||
Enrolling by invitation |
NCT05890274 -
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
|
N/A | |
Recruiting |
NCT05316870 -
Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation
|
N/A | |
Recruiting |
NCT05266144 -
Atrial Fibrillation Patients Treated With Catheter Ablation
|
||
Not yet recruiting |
NCT06023784 -
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
Completed |
NCT04087122 -
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
|
N/A | |
Completed |
NCT06283654 -
Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
|
||
Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|
||
Completed |
NCT04546763 -
Study Watch AF Detection At Home
|
||
Completed |
NCT03761394 -
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
|
N/A |