Clinical Trials

Date: 2017-02-08

Type of information: DSMB assessment

phase: 3

Announcement: DSMB assessment

Company: Bayer Healthcare (Germany)

Product: Xarelto® (rivaroxaban)

Action mechanism: anticoagulant agent/oral direct Factor Xa inhibitor

Disease: prevention of major adverse cardiac events (MACE) including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease (CAD) or peripheral artery disease (PAD)

Therapeutic area: Cardiovascular diseases

Country: Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Republic of Korea, Malaysia, The Netherlands, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Sweden, Switzerland, Ukraine, UK, USA

Trial details:

• The Phase III study COMPASS (Cardiovascular OutcoMes for People using Anticoagulation StrategieS) will include approximately 20,000 patients from more than 450 sites across more than 25 countries worldwide. Patients with documented atherosclerosis related to CAD or PAD will be enrolled into the study. The primary efficacy endpoint is a composite of cardiovascular death, myocardial infarction and stroke. The primary safety endpoint is major bleeding. In the study, patients will be randomized to receive either rivaroxaban 2.5 mg twice-daily in addition to aspirin 100 mg once-daily, rivaroxaban 5 mg twice-daily alone, or aspirin 100 mg once-daily alone. The study will be conducted by the Population Health Research Institute (PHRI), a leading academic health science research organization based in Hamilton, Ontario, Canada. (NCT01776424)

Latest news:

• • On February 8, 2017, Bayer and its cooperation partner Janssen Research & Development announced that the Phase III trial COMPASS evaluating the efficacy and safety of rivaroxaban (Xarelto®) for the prevention of major adverse cardiac events (MACE) including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease (CAD) or peripheral artery disease (PAD) has met its primary endpoint ahead of time. Following a planned interim analysis conducted by the independent Data Monitoring Committee (DMC), the DMC recommended to stop the trial early as the primary MACE endpoint has reached its prespecified criteria for superiority. Owing to the magnitude of effect and the confirmation of the existing safety profile of rivaroxaban, Bayer, Janssen and the Population Health Research Institute (PHRI) will offer rivaroxaban to study participants in an open-label extension trial.
• The Phase III COMPASS study was conducted in collaboration with the PHRI and has enrolled 27,402 patients from more than 600 sites across more than 30 countries worldwide. In the study, patients were randomized to receive either rivaroxaban 2.5 mg twice daily in addition to aspirin 100 mg once daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg once daily alone. A complete data analysis from this study is expected to be presented at an upcoming medical meeting in 2017.
• • On November 13, 2012, Bayer HealthCare has announced the initiation of the COMPASS study, the largest clinical study of its oral anticoagulant Xarelto® (rivaroxaban) to date, investigating the prevention of major adverse cardiac events (MACE) including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease (CAD) or peripheral artery disease (PAD).
• In CAD and PAD, the inner wall of the arteries progressively thickens due to accumulation of lipids, calcification and cell proliferation. This plaque narrows the arteries and decreases the amount of blood flow to the heart muscle or the legs. This process is called atherosclerosis. If plaque from the wall of an artery ruptures, a blood clot can form at the site of the rupture leading to serious events including myocardial infarction, stroke or even death. Currently, the most commonly prescribed treatments for the prevention of MACE in CAD and PAD patients are antiplatelet agents such as aspirin - a product with a well documented role in the prevention of cardiovascular events across a broad range of patients.
• The Phase III study COMPASS will assess the potential of rivaroxaban to provide important additional protection to patients when added to aspirin as compared to rivaroxaban and aspirin as single treatments.

Is general: Yes