Study Design

Study Design:

Patients Screened: 513
Patients Enrolled: 115
Mean Patient Age: mean age 56 years
Female: 27

Patient Populations:

Age 16 and 80 years with native valve or prosthetic valve endocarditis, defined as two of the following three criteria: 1) multiple positive blood cultures (at least two sets) with no known extracardiac source; 2) echocardiographic evidence of vegetation, defined as a localized, mobile mass contiguous with a valve leaflet or prosthetic valve; and 3) at least two of the following clinical findings: fever, new or changing heart murmur, pre-existing heart disease, and microvascular phenomena

Exclusions:

Isolated right-sided endocarditis, echocardiographic evidence of perivalvular abscess (defined as an abnormal echolucent mass within the perivalvular tissue), probable surgical intervention within seven days, current use of aspirin, recent or actively evolving stroke, history of gastrointestinal bleeding or active peptic ulcer disease within the past 12 months, history of a bleeding diathesis, allergic or intolerance to aspirin, and inability or unwillingness to provide informed consent

Primary Endpoints:

Clinical embolic events involving the brain or other organs

Secondary Endpoints:

Cerebral hemorrhage, subclinical strokes detected by cerebral computed tomography, death, major or minor bleeding, valve surgery, and echocardiographic progression of valvular involvement

Drug/Procedures Used:

Patients were randomized to either aspirin (325 mg/day; n=60) or placebo (n=55) for four weeks.

Concomitant Medications:

All patients were on antibiotic therapy. Anticoagulation therapy was continued in patients with mechanical prosthetic valves.