Summary

• In ROCKET AF, patients were excluded if they had a platelet count less than 90,000/μL at the screening visit.¹
• There were 19 (1.1%), 23 (1.0%), and 2 (0.3%) of patients receiving XARELTO with baseline thrombocytopenia in the EINSTEIN-DVT, EINSTEIN-PE, and EINSTEIN-Extension studies, respectively.^2-4
• In the EINSTEIN CHOICE study, there were 6 (0.5%) and 4 (0.4%) of patients with baseline thrombocytopenia receiving XARELTO 10 mg and XARELTO 20 mg, respectively.⁵
• In three of the four phase 2 ODIXa studies, patients were excluded if they had a baseline platelet count less than 100,000/µL. In one of the four ODIXa phase 2 studies, patients were excluded if they had a baseline platelet count less than 50,000/µL.^6-9
• In ATLAS ACS TIMI-51, patients were excluded if they had a platelet count less than 90,000/μL at baseline.¹⁰
• In the VOYAGER PAD study, 1 (<0.1%) patient in the placebo + aspirin group had baseline thrombocytopenia, compared to none in the XARELTO + aspirin group.¹¹

CLINICAL STUDIES

Stroke Prevention in Nonvalvular Atrial Fibrillation

The ROCKET AF trial evaluated the efficacy and safety of XARELTO and warfarin for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation at moderate-to-high risk for stroke.¹

In ROCKET AF, patients were excluded if they had a platelet count less than 90,000/μL at the screening visit.¹

Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and Reduction in the Risk of Recurrence of DVT and of PE

EINSTEIN-DVT

EINSTEIN-DVT was a phase 3, randomized, open-label, event-driven, noninferiority study that compared oral XARELTO alone (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with subcutaneous enoxaparin (1.0 mg/kg twice daily) followed by dose-adjusted oral vitamin K antagonist (VKA) (warfarin or acenocoumarol) in patients with confirmed symptomatic DVT without symptomatic PE.¹²

EINSTEIN-PE

EINSTEIN-PE was a phase 3, randomized, open-label, event-driven, noninferiority study evaluating the efficacy and safety of oral XARELTO (15 mg twice daily for 3 weeks followed by 20 mg once daily) vs subcutaneous enoxaparin (1.0 mg/kg twice daily) followed by dose-adjusted oral VKA in patients with acute symptomatic PE with or without DVT.¹³

EINSTEIN-Extension

EINSTEIN-Extension was a phase 3, randomized, double-blind, event-driven superiority study comparing XARELTO 20 mg once daily to placebo in patients with confirmed symptomatic PE or DVT who have been treated for 6 to 12 months with XARELTO or VKA.¹²

For rates of baseline thrombocytopenia in the EINSTEIN program, see Table: Rates of Baseline Thrombocytopenia in the EINSTEIN Program (Intention-to-Treat Population).

EINSTEIN CHOICE

EINSTEIN CHOICE was a phase 3, randomized, double-blind study comparing the efficacy and safety of XARELTO 10 mg and XARELTO 20 mg with aspirin 100 mg in patients with DVT or PE who had completed 6 to 12 months of anticoagulation therapy.¹⁴

• There were 6 (0.5%), 4 (0.4%), and 3 (0.3%) patients with baseline thrombocytopenia receiving XARELTO 10 mg once daily (OD), XARELTO 20 mg OD, and aspirin 100 mg OD, respectively.⁵

Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery

As part of the phase 2 ODIXa (Oral, DIrect factor Xa inhibitor) clinical study program, 4 randomized, dose-ranging studies compared XARELTO to enoxaparin for VTE prevention (3 studies in patients undergoing total hip replacement surgery and 1 study in patients undergoing knee replacement surgery).^15-18 Based on the results of these studies, a dose regimen of 10 mg once daily was selected to be used in subsequent phase 3 clinical studies in VTE prevention in total hip and knee replacement (phase 3 RECORD clinical trial program).

In three of the four phase 2 ODIXa studies, patients were excluded if they had a baseline platelet count less than 100,000/µL.^7-9 In one of the four ODIXa Phase 2 studies, patients were excluded if they had a baseline platelet count less than 50,000/µL.⁶

Acute Coronary Syndrome (ACS)

ATLAS ACS TIMI-51 was a randomized, multicenter, double-blind, event-driven study to determine whether XARELTO, when added to standard care, was safe and reduced the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with ACS compared with placebo.¹⁰

In ATLAS ACS TIMI-51, patients were excluded if they had a platelet count less than 90,000/μL at baseline.¹⁰

Peripheral Artery Disease (PAD)

VOYAGER PAD was a phase 3, randomized, multicenter, double-blind, placebo-controlled, endpoint-driven study comparing the efficacy of XARELTO 2.5 mg twice daily (BID) plus aspirin 100 mg OD with placebo plus aspirin 100 mg OD in patients with symptomatic PAD who had undergone revascularization.¹⁹

• One (<0.1%) patient in the placebo + aspirin group had baseline thrombocytopenia, compared to none in the XARELTO + aspirin group.¹¹

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 30 May 2024.