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

Description

Postoperative atrial fibrillation (POAF) is a common complication after heart surgery. Amiodarone is the drug of choice to treat POAF. Inflammation is considered one of underlying factor for POAF. Minocycline is an antibiotic with anti-inflammatory properties.

Study Start Date

October 2011

Estimated Completion Date

March 2017

Interventions

  • Drug: Amiodarone
  • Drug: Minocycline

Specialties

  • Cardiology: Arrhythmias/EP,Cardiac Surgery,Clinical Pharmacology,Prevention
  • Surgery: Cardiac Surgery,Clinical Pharmacology,Patient Management
  • Anesthesiology: Cardiothoracic,Critical Care,Pharmacology/kinetics
  • Pharmacy: Cardiac/Hypertension,Drug Interactions,Drug Trials

MeSH Terms

  • Atrial Fibrillation
  • Cardiac Surgical Procedures

Study ID

Baystate Medical Center -- BH-09-176

Status

Unknown

Trial ID

NCT01422148

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

40

Sponsor

Baystate Medical Center

Inclusion Criteria

    -Eligibility criteria includes all non-congenital cardiac operations are included:
  • coronary artery bypass graft (CABG),
  • valve repair/replacement, or
  • combination of CABG and heart valve operations.

Exclusion Criteria

  • prior (within 6 months) or current PAF or flutter,
  • prior cerebrovascular event,
  • cardiogenic shock or resuscitation,
  • evidence of hepatic or renal dysfunctions (i.e., an alanine aminotransferase level that is >= twice the upper limit of the normal range, or either a serum creatinine level that is >= 2.0 mg/dL or need for preoperative dialysis),
  • thyrotoxicosis,
  • pregnancy,
  • severe COPD (FEV1/FVC <70%),
  • recent history of drug or alcohol abuse, and
  • intolerance to tetracycline or amiodarone. Finally, because a core scientific basis of the trial concerned the role of underlying atrial tissue inflammatory activity, patients with inflammatory conditions such as lupus, severe arthritis, thyroiditis or inflammatory bowel disease are excluded
  • as are patients taking preoperative immunosuppressant agents, long-term oral corticosteroids, or estrogen replacement and a newly diagnosed cancer (<5 years).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Baystate Medical Center - Springfield, Massachusetts 78.8 miles None None None
Baystate Medical Center - Springfield, Massachusetts 78.8 miles Barbara Burkott BN BSNCCRP 413-794-0000 barbara.burkott@baystatehealth.org

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