Clinical Trials

Date: 2015-05-20

Type of information: Presentation of results at a congress

phase: 3

Announcement: presentation of results at the Heart Rhythm Society’s 36th Annual Scientific Sessions

Company: Bayer Healthcare (Germany) Janssen Pharmaceuticals, a J&J company (USA - NJ)

Product: Xarelto® (rivaroxaban)

Action mechanism: anticoagulant agent/oral direct Factor Xa inhibitor

Disease: atrial fibrillation

Therapeutic area: Cardiovascular diseases

Country: Belgium, France, Germany, UK, USA

Trial details:

VENTURE-AF was a randomised, open-label, comparative Phase IIIb exploratory trial; the first prospective study of a novel oral anticoagulant in these patients. 248 patients were randomised from 37 sites across five countries (Belgium, France, Germany, UK and US). Patients with AF scheduled for catheter ablation were randomly assigned in a 1:1 ratio to rivaroxaban 20 mg orally once-daily or to dose-adjusted VKA (target INR 2.0-3.0). (NCT01729871)

Latest news:

• On May 20, 2015, Bayer HealthCare and its development partner Janssen Pharmaceuticals announced results from the VENTURE-AF trial. In this study, once-daily Xarelto® (rivaroxaban) was investigated as an alternative to dose-adjusted Vitamin K Antagonists (VKAs) to reduce the risk of blood clots in patients with non-valvular atrial fibrillation (AF) undergoing catheter ablation. Results of the VENTURE-AF study were presented as a late breaking presentation at the Heart Rhythm Society’s 36th Annual Scientific Sessions, taking place from May 13-16 in Boston, US and were published simultaneously in the European Heart Journal. VENTURE-AF was a randomised, open-label, comparative Phase IIIb exploratory trial; the first prospective study of a novel oral anticoagulant in these patients. Patients with AF scheduled for catheter ablation were randomly assigned in a 1:1 ratio to rivaroxaban 20 mg orally once-daily or to dose-adjusted VKA (target INR 2.0-3.0). In patients treated with rivaroxaban, there were no thromboembolic events. In those patients receiving a VKA, two thromboembolic events (one vascular death and one ischaemic stroke) occurred. There was one ISTH major bleeding event in the VKA treatment arm versus none in the rivaroxaban treatment group. There were no major bleeding events in either group using TIMI and GUSTO-defined scales. The incidence of non-major bleeding events and procedure-attributable events was low for both treatment arms.