A Study to Evaluate the Efficacy and Safety of Fondaparinux Sodium When Used With Intermittent Pneumatic Compression to Prevent Venous Thromboembolic (IPC) Versus IPC Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdominal Surgery (APOLLO).

Phase 3 Completed 1309 enrolled GlaxoSmithKline Sanofi · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a multicentre, randomized, double-blind, placebo controlled study. During this study all the patients will receive background venous thromboembolism (VTE) mechanical prophylaxis with intermittent pneumatic compression (IPC).

Timeline

Start: 2001-11
Primary completion: 2004-10
Completion: 2004-10

Outcome

Met primary endpoint

paper The venous thromboembolism rate was 1.7% (7/424) in the fondaparinux-treated patients and 5.3% (22/418) in the placebo-treated patients PMID 17723125 ↗

paper odds ratio reduction 69.8%; 95% confidence interval 27.9-87.3; P = 0.004 PMID 17723125 ↗

Publications

Results Turpie AG, Bauer KA, Caprini JA, Comp PC, Gent M, Muntz JE; Apollo Investigators. Fondaparinux combined with intermittent pneumatic compression vs. intermittent pneumatic compression alone for prevention of venous thromboembolism after abdominal surgery: a randomized, double-blind comparison. J Thromb Haemost. 2007 Sep;5(9):1854-61. doi: 10.1111/j.1538-7836.2007.02657.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fondaparinux	Other / unclassified	2.5 mg	Subcutaneous