DSI: Joseph Saponaro

Dabigatran SPAF

Efficacy and safety of Dabigatran etexilate for the prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation in comparison to Warfarin. A prospective, randomized, open label controlled, multicenter, parallel-group trial.

Sponsor: Boehringer Ingelheim
Study Drug: Dabigatran Etexilate (BIBR 1048 MS) 110 mgm (Two Caps = 220 mgm) Once daily
Protocol: 1160.26
Phase III
CRO:
CRA:
SAE Hotline ->
Project Manager:
Site #:
Central Lab:
Last day to enroll subjects:
Central IRB:
10,000 Subjects/800 Sites = 13 pts per site; equally divided into 2 treatment arms: Coumadin vs. Dabigatran
Study Duration: one to three years
Study Population: Patients with moderate to high risk, non-valvular AF with an additional Risk Factor for stroke or systemic embolism including: (prior CVA, TIA, or systemic embolism, LV dysfunction, HTN, Age ? 75 or ? 65 if DM or CAD) DTI (Direct Thrombin Inhibitor): AZ ? Exanta® or Ximelagatran studied in the SPORTIF Trial

IC
Age ? 18
AF
An Additional RF for Stroke ? Prior CVA, TIA, or Systemic Embolism, LV dysfunction, HTN, Age ? 75 or ? 65 if DM or CAD

EC
Hemodynamically relevant VHD
Major Surgery x 1 month or planned in the next three months
Severe disabling CVA
GI Bleed x 1 year
CRF with CC < 30
ASA > 81 mg or Plavix
Unc. HTN
Hepatitis
Cancer < 6 months

V1 D -21 to 0
V2 D 1
V3 D
V4 D 15
V5 D 22
V6 D 29
V7 D 32
V8 D 42
V9 D 90