Cardiology Research, ISSN 1923-2829 print, 1923-2837 online, Open Access
Article copyright, the authors; Journal compilation copyright, Cardiol Res and Elmer Press Inc
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Volume 6, Number 3, June 2015, pages 267-277

Unmet Needs in Anticoagulant Therapy: Potential Role of Rivaroxaban


Figure 1.
Figure 1. Clinical settings for oral anticoagulation. Clinical questions about the management of the NOACs exist in each of these settings.
Figure 2.
Figure 2. Study design of COMPASS. To assess the safety and efficacy of rivaroxaban for the prevention of MI, stroke, and CV death, patients with coronary artery disease (CAD) or peripheral artery disease (PAD), who do not require dual antiplatelet therapy (DAPT), are randomized to rivaroxaban 2.5 mg BID + acetylsalicylic acid (ASA) 100 mg QD; rivaroxaban 5 mg BID; or ASA 100 mg QD. *Patients in each arm are also randomized to pantoprazole 40 mg QD or placebo to investigate if safety can be improved by the addition of a proton pump inhibitor.
Figure 3.
Figure 3. Study design of COMMANDER-HF. To determine whether rivaroxaban reduces the risk of MI, stroke or death, patients with a history of coronary artery disease (CAD) or those recently hospitalized for an exacerbation of their heart failure (HF) are randomized to rivaroxaban 2.5 mg BID or placebo in addition to their current standard of care.


Table 1. Ongoing Studies With Rivaroxaban Addressing Unresolved Issues in Established Indications
TrialClinical question(s) to be addressedArmsTargeted enrollment
*P2Y12 inhibitor such as clopidogrel (75 mg QD). ACS: acute coronary syndrome; AF: atrial fibrillation; ASA: acetylsalicylic acid; DAPT: dual antiplatelet therapy; LA: left atrial; PCI: percutaneous coronary intervention; SVT: superficial vein thrombosis; UFH: unfractionated heparin; VKA: vitamin K antagonist; VTE: venous thromboembolic events.
Stroke prevention in patients with AF
Does rivaroxaban need to be stopped prior to catheter ablation in patients with non-valvular AF?Rivaroxaban 20 mg QD
VKA (INR 2.0-3.0)
Does treatment with rivaroxaban regress LA thrombi in patients with non-valvular AF or atrial flutter?Rivaroxaban 20 mg QD60
VTE treatment
Can a lower dose (10 mg) of rivaroxaban be used for the long-term prevention of VTE, and is this or 20 mg rivaroxaban superior to ASA?Rivaroxaban 10 mg QD
Rivaroxaban 20 mg QD
ASA 100 mg QD
Can rivaroxaban be safely used in children?Rivaroxaban (age and weight adjusted)
Standard of care
  Superficial vein thrombosis
Can rivaroxaban be used to treat SVT?Rivaroxaban 20 mg QD506
Prevention of VTE
Can rivaroxaban reduce the risk of post-hospital discharge symptomatic VTE in patients hospitalized for acute medical illness?Rivaroxaban 10 mg QD or 7.5 mg QD (adjusted for creatine clearance)
Is rivaroxaban more effective than ASA for extended prophylaxis of VTE?Rivaroxaban 10 mg QD
Fondaparinux 2.5 mg QD
Therapeutic approaches for patients with coronary disease
Can rivaroxaban, in combination with a single antiplatelet agent, be used for secondary prevention in patients with ACS?Study design not released at the time of publication3,000
Can rivaroxaban prevent thrombosis and related adverse ischemic events during elective PCI?Rivaroxaban 20 mg QD
Rivaroxaban 10 mg QD
Rivaroxaban 10 mg QD + UFH 50 IU/kg bolus
UFH 70-100 IU/kg bolus
Should rivaroxaban be used over warfarin in patients who have undergone PCI and are on antiplatelet therapy? If so, what is the optimal rivaroxaban dose and antiplatelet regimen for these patients?Rivaroxaban 15 mg QD + P2Y12 inhibitor*
Rivaroxaban 2.5 mg BID + DAPT


Table 2. Ongoing Studies With Rivaroxaban in Potential New Indications
TrialClinical question(s) to be addressedArmsEstimated enrollment
ASA: acetylsalicylic acid; CAD: coronary artery disease; ESUS: embolic stroke of undetermined source; HIT: heparin-induced thrombocytopenia; PAD: peripheral artery disease; TIA: transient ischemic attack.
Secondary prevention of cardiovascular disease
Does rivaroxaban provide additional cardioprotective benefits to high-risk patients?
Should rivaroxaban be used alone or in combination with ASA in patients with CAD or PAD?
Rivaroxaban 2.5 mg BID + ASA
Rivaroxaban 5.0 mg BID
ASA 100 mg QD
Heart failure
Does adding low-dose rivaroxaban to optimal medical therapy improve outcomes in heart failure?Rivaroxaban 2.5 mg BID + single or dual antiplatelet therapy
Single or dual antiplatelet therapy
Confirmed or suspected HIT
  Heparin-induced thrombocytopenia
Can rivaroxaban be used to treat HIT?Rivaroxaban 15 mg BID until HIT excluded, followed by rivaroxaban 20 mg QD200
Stroke prevention in patients with ESUS
Is rivaroxaban more effective than ASA atreducing the risk of recurrent stroke and systemic embolism in patients with a recent ESUS?Rivaroxaban 15 mg QD
ASA 100 mg QD
Treatment of high-risk patients with non-disabling cerebrovascular events
Should rivaroxaban be used over ASA in patients following TIA or minor ischemic stroke?ASA 100 mg QD
Rivaroxaban 5 mg
Rivaroxaban 10 mg