1. ACC 2003 Late Breaking Trials
SPORTIF III Trial
Stroke Prevention Using the Oral Direct Thrombin Inhibitor Ximelagatran in Patients With Nonvalvular Atrial Fibrillation
Lancet 2003; 362: 1691–98
Presented at
ACC 2003 Late Breaking Trials

2. Randomized Open-label to:
SPORTIF III Trial
3,407 patients with nonvalvular AF and risk factors for stroke (previous stroke, hypertension, or CHF)
Randomized Open-label to:
Ximelagatran (36 mg bid)
A novel, oral direct thrombin inhibitor ximelagatran
(n = 1,704)
Warfarin
Target INR
(n = 1,703)
Endpoints (mean follow-up 17 months):
Primary – Prevention of all strokes (ischemic or hemorrhagic) and systemic embolic events, based on intention-to-treat
Secondary – Composite of death, stroke, systemic embolism, and MI; and safety variables, specifically bleeding and treatment discontinuation
ACC 2003; Lancet 2003; 362: 1691–98

3. SPORTIF III Trial: Primary Analysis (Intention-to-Treat)
Stroke and Systemic Embolism
ACC 2003; Lancet 2003; 362: 1691–98

4. SPORTIF III Trial: On-Treatment Analysis
Stroke and Systemic Embolism
ACC 2003; Lancet 2003; 362: 1691–98

5. SPORTIF III Trial: Bleeding Events
Event Rate (% per year)
p=NS
p=NS
ICH
Major Bleed
Major + Minor Bleed
ACC 2003; Lancet 2003; 362: 1691–98

6. SPORTIF III Trial: Adverse Events
p=NS
Event Rate (% per year)
CHF MI
All-cause Mortality
ACC 2003; Lancet 2003; 362: 1691–98

7. SPORTIF III Trial: Liver Enzyme Elevation
ALT >3x ULN
p<0.001
Ximelagatran
Warfarin
ACC 2003; Lancet 2003; 362: 1691–98