Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Venous Thromboembolism

In brief

This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.

Key facts

Study ID

NCT00571649

Run by

Bayer

People needed

8101

Starts

2007-12-01

Expected to finish

2010-11-01

Last updated by the study team

2016-09-15

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients aged 40 years or more
• Patients at risk of venous thromboembolic events being hospitalized for acute medical conditions as follows:
• Heart failure, New York Heart Association (NYHA) class III or IV
• Active cancer
• Acute ischemic stroke
• Acute infectious and inflammatory diseases, including acute rheumatic diseases
• Acute respiratory insufficiency
• Additional risk factor for VTE, including reduced mobility

You may not qualify if…

• Conditions that contraindicate the use of antithrombotic therapy with the Low Molecular-Weight Heparin (LMWH) enoxaparin
• Conditions that may increase the risk of bleeding, including intracranial hemorrhage
• Required drugs or procedures which may interfere with the study treatment
• Concomitant conditions or diseases which may increase the risk of study subjects or interfere with the study outcome
• General conditions in which subjects are not suitable to participate in the study

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Dothan, Alabama, United States
• Office of Dr. John Simmons, MD — Geneva, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Montgomery, Alabama, United States
• Study site — Tuscaloosa, Alabama, United States
• Study site — Tuscaloosa, Alabama, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Chula Vista, California, United States
• Study site — Duarte, California, United States
• Study site — Encinitas, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Fullerton, California, United States
• Study site — Glendale, California, United States
• Study site — Oceanside, California, United States
• Study site — Pasadena, California, United States
• Study site — Redlands, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Barbara, California, United States
• Study site — Torrance, California, United States
• Study site — Denver, Colorado, United States
• Study site — Pueblo, Colorado, United States
• Study site — Wheat Ridge, Colorado, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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