Minocycline Plus Amiodarone Versus Amiodarone Alone for the Prevention of Atrial Fibrillation After Cardiac Surgery

NCT01422148 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: BH-09-176
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

. New- onset postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery and its occurrence increases with age. POAF can result in clinically significant morbidity and mortality. The national trend in the US is that the population older than 65 years is increasing, making healthcare expenditure related to POAF to be a major burden on health care system. Effective treatment of POAF is imperative in ensuring quality of care and reduction of costs. In 2021 there is a projected total of 377,763 cardiovascular surgeries in the US alone with approximately half of which will have POAF with longer postoperative length of stay (+3.9 days) and higher discharge costs (+$13,993) than no-POAF patients (Reference: Ann Thorac Surg. 2015 Jan;99(1):109-14). Amiodarone, the currently used therapy, is often insufficient to prevent POAF and has multiple side-effects. In this study, we expect to improve the incidence of POAF by using a common acne drug (Minocycline) that is safe and that could be incorporated in clinical care of this disease.

Conditions

Atrial Fibrillation

Keywords

cardiac surgery; atrial fibrillation; minocycline; amiodarone

Outcome Measures

Primary Outcomes (1)

• Post-op Atrial Fibrillation

  frequency of a newly detected episode of POAF occuring after the initial surgery, or within 6 weeks after hospital discharge

  6 weeks

Secondary Outcomes (3)

• Thromboembolism

  6 weeks

• Heart failure

  6 weeks

• 30-day hospital death

  30-days

Study Arms (2)

Amiodarone

OTHER

oral amiodarone

Drug: Amiodarone

minocycline

EXPERIMENTAL

intravenous minocycline 100 mg daily x 5 days starting intra-operatively combined with oral amiodarone (400 mg twice daily for 7 days, then 200 mg twice daily for the next 7 days

Drug: Amiodarone; Drug: Minocycline

Interventions

Amiodarone DRUG

oral amiodarone (400 mg twice daily for 7 days, then 200 mg twice daily for the next 7 days

Amiodarone; minocycline

Minocycline DRUG

intravenous minocycline 100 mg daily x 5 days starting intra-operatively combined with oral amiodarone (400 mg twice daily for 7 days, then 200 mg twice daily for the next 7 days

Also known as: Minocin

minocycline

Eligibility Criteria

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

Sponsors & Collaborators

• Baystate Medical Center: lead

Study Sites (1)

Abdallah Alameddine

Melrose, Massachusetts, 02176, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; cyclopia sequence

Interventions

Amiodarone; Minocycline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Abdallah k Alameddine, MD

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdallah Alameddine, MD

CONTACT

17815212074; akalameddine@gmail.com

Abdallah k Alameddine, md

CONTACT

413 794-0000; akalameddine@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Staff

Study Record Dates

• First Submitted: August 17, 2011
• First Posted: August 23, 2011
• Study Start: July 1, 2025
• Primary Completion (Estimated): January 24, 2027
• Study Completion (Estimated): January 24, 2028
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Three years
• Access Criteria: de-identified computerized dataset

Locations

US (1)