Clinical trials in which faculty have been principal investigators:

1. 2004 Clinical Utility of CaduetÒ in Simultaneously Achieving Blood Pressure and Lipid Endpoints in a Specific Patient Population (CAPABLE).  Protocol Number: A3841025- 2004.

2. 2006 EQUINOX International, multicenter, randomized, parallel group, double-blind study, in patients with acute symptomatic deep vein thrombosis of the lower limbs, demonstrating the bioequipotency at steady state of equimolar doses of SSR126517E (3.0 mg) once a week and SR34006 (2.5 mg) once a week, documenting the safety and efficacy of both compounds during a 6- month treatment, and demonstrating the neutralizing effect of SSR29261E on the SSR126517E- induced anti-Xa activity, Protocol Number: EFC59452006.

3. 2006 CASSIOPEA An international, multicenter, randomized, double-blind, double-dummy, parallel group, study of 3-month or 6-month treatment with SSR126517E (3.0 mg s.c. once weekly) versus oral INR-adjusted warfarin in the treatment of patients with symptomatic pulmonary embolism, with or without symptomatic deep venous thrombosis. Protocol Number:  EFC 6034, 2006.

4. 2006 A multi-center, prospective, randomized double-blind, placebo- controlled phase III clinical outcome study to examine the long-term safety and efficacy of Veliflapon (DG-031) in reducing the risk of acute cardiovascular events by its effect on leukotrienes in African American patients with Coronary Artery Disease and leukotriene gene markers. The LTCAD Study, Protocol Number:  DG-031-CV-301, deCODE genetics, Inc-2006 (terminated by sponsor Oct 2006).

 5. 2007 RE-SONATE  Twice-daily oral direct thrombin inhibitor dabigatran etexilate in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism.

6. 2007.  Study evaluating the use of acid suppression therapy for stress ulcer prophylaxis in non-ICU patients (submitted for IRB approval 11/07).

7. 2007.  Study evaluating the rate of primary prevention of glucocorticoid-induced osteoporosis (submitted for IRB approval  11/07).

8. 2007.  Multicenter, randomized, double blind, parallel design trial to evaluate the BP lowering efficacy comparing moderate versus aggressive treatment regimen of Exforge® (amlodipine/ valsartan) in patients that were previously uncontrolled on ARB monotherapy.  Clinical Trial Protocol CVAA489AUS 02A.

9. 2008.  Multicenter, randomized, double-blind, assessor-blind, non-inferiority study comparing the efficacy and safety of one-weekly subcutaneous biotinylated idraparinux with oral adjusted-dose warfarin in the prevention of stroke and systemic thromboembolic events in patients with atrial fibrillation.  Clinical trial protocol number: EFC10295.

10. 2009. borealis. A multicenter, randomized, double-blind, assessor-blind, non-inferiority study comparing the efficacy and safety of once-weekly subcutaneous biotinylated idraparinux (SSR126517E) with oral adjusted-dose warfarin in the prevention of stroke and systemic thromboembolic events in patients with atrial fibrillation.

11. 2009.  Two trials investigating apixiban: (1) DVT prevention in medically ill patients, and (2) Apaxiban treatment of symptomatic DVT/PE.

12. 2009. Multicenter, randomized, double-blind study comparing efficacy and safety of AVE5026 with enoxoparin for the primary prevention of VTE in acute medically ill patients with restricted mobility.

13. 2011 A randomized , open label  efficiency and safety study of Octaplex (prothrombin complex concentrate) and fresh frozen plasma in patients on vit K antagonist (warfarin) therapy with the need for urgent surgery or invasive procedures.