Study protocol for aspirin plus rivaroxaban efficacy and safety in embolic stroke of undetermined source: A randomized, placebo controlled, outcome assessor blind, feasibility study

Abstract

Background & Objectives: Despite recent scientific advances in acute ischemic stroke treatment, there has been limited progress for the secondary prevention of cryptogenic ischemic stroke. The present proposed study is designed for evaluation of efficacy and safety of rivaroxaban plus aspirin in reducing stroke recurrence in patients with embolic stroke of undetermined source (ESUS). Methods: This is a randomized, parallel-group, outcome assessor blind, placebo-controlled study on the recent (7-60 days) ESUS patients identified only one risk factor of potential embolic source. After meeting all inclusion and exclusion criteria patients will be randomized to rivaroxaban 2.5 mg BID plus ASA 80 mg daily or ASA 80 mg plus placebo (1:1 ratio) and will be visited every three months until one year. Any adverse events, serious side effects, outcome events will be recorded. Results: The primary outcome is defined as the rate and time of stroke occurrence and major bleeding events. Conclusions: Low dose rivaroxaban plus aspirin is expected to be a safe and effective for prevention of recurrence in ESUS.