@article{7ccae1299dfc469b9329d111a1e041b7,
title = "Treatment of proximal deep vein thrombosis with a novel synthetic compound (SR90107A/ORG31540) with pure anti-factor Xa activity: A phase II evaluation",
abstract = "Background - Patients with venous thromboembolism require initial treatment with an immediate-acting anticoagulant, low-molecular-weight heparin. We evaluated a novel synthetic factor Xa inhibitor (SR90107a/ORG31540) as an alternative treatment. Methods and Results - A randomized-parallel-group, phase II trial to assess the efficacy and safety of SR90107a/ ORG31540 (5, 7.5, or 10 mg once daily) relative to low-molecular-weight heparin (dalteparin, 100 IU/kg twice daily) in symptomatic proximal deep vein thrombosis. The primary outcome measure was the change in thrombus mass, assessed by ultrasonography of the leg veins and perfusion lung scintigraphy, performed at baseline and day 7 ± 1. A positive outcome was defined as improvement of the ultrasound and/or perfusion scan result without deterioration of either test. Other outcome measures included symptomatic, recurrent venous thromboembolism and major bleeding for a period of 3 months. All outcomes were interpreted with the observer unaware of treatment allocation. A positive primary outcome was observed in 46 of 100 (46%), 52 of 108 (48%), 48 of 115 (42%), and 56 of 115 (49%), respectively, of the subjects given 5, 7.5, or 10 mg SR90107a/ORG31540 or dalteparin. There were 8 recurrent thromboembolic complications (2.4%) in the 334 patients treated with SR90107a/ORG31540 and 6 (5.0%) in the 119 dalteparin patients, a difference of 2.6% in favor of SR90107a/ORG31540 (95% CI -2.1% to 10.1%). The incidence of bleeding was low and was similar among the groups. Conclusions - The factor Xa inhibitor SR90107a/ORG31540 appears to be an effective and safe treatment for patients with deep vein thrombosis across a wide range of doses. This synthetic compound merits evaluation in phase III studies.",
keywords = "Anticoagulants, Heparin, Imaging, Thrombosis",
author = "{Rembrandt Investigators} and Buller, {H. R.} and R. Cariou and A. Gallus and M. Gent and J. Ginsberg and Prins, {M. H.} and A. Lensing and M. Levi and N. Nurmohammed and J. Hirsh and R. Roberts and {Ten Cate}, {J. W.} and H. Decousus and P. Mismetti and A. Buchmuller and V. Charlet and A. Viallon and {Van der Meer}, J. and Meinardi, {J. R.} and K. Meijer and F. Piovella and M. Barone and C. Beltrametti and S. Serafini and Kraaijenhagen, {R. A.} and Koopman, {M. M.W.} and Jagt, {H. H.T.} and Muller, {M. B.R.} and {Van Marwij Kooy}, M. and S. Nauta and A. Gallus and D. Coghlan and C. Rich and P. Prandoni and A. Scudeller and L. Scarano and A. Girolami and R. Baker and E. Tan and J. Cooney and J. Eikelboom and J. Ninet and C. Dolmazon and {Girard Madoux}, {M. H.} and B. Coppere and Nenci, {G. G.} and G. Agnelli and F. Falcinelli and M. Morini and Raffaele, {H. S.} and A. D'Angelo and L. Crippa and {Vigano d'Angelo}, S. and B. Chong and C. Chestreman and J. Malvin and M. Eisbascher and MacGillavry, {M. R.} and Brandjes, {D. P.M.} and Beaumont, {J. F.M.} and {Valdes Olmos}, {R. A.} and Turpie, {A. G.G.} and J. Johnson and B. Nowacki and D. Anderson and S. Pleasance and M. Mitchell and P. Ockelford and A. Bennett and R. Jones and F. Porteous and J. Weitz and C. Kearon and G. Simonneau and F. Parent and J. Douketis and T. Schnurr and P. Hainaut and B. Petit and C. Jaumotte and Huisman, {M. V.} and {Van Poelgeest}, {M. I.E.} and Meinders, {A. E.} and {Van Oostayen}, {J. A.} and J. Beer and A. Lugli and S. Pederiva and J. Ginsberg and P. Brill-Edwards and P. Stevens and Bassand, {J. P.} and Seronde, {M. F.} and J. Kassis and M. Fortin and R. Faivre and Petiteau, {P. Y.} and R. Verhaeghe and P. Wells and B. Lewandowski and D Touchie and J.D. Banga and I.J.C. Hartmann and V.J.M. Zeguers and L. Desjardins and J. Villeneuve and J. Cote and H. Bounameaux and P. Cirafici and C. Demers and {van der Heul}, C.",
year = "2000",
month = nov,
day = "28",
doi = "10.1161/01.CIR.102.22.2726",
language = "English",
volume = "102",
pages = "2726--2731",
journal = "Circulation",
issn = "0009-7322",
publisher = "LIPPINCOTT WILLIAMS & WILKINS",
number = "22",
}