Approximately 17% of all patients with stroke are classified as having ESUS, which is associated with a considerable rate of stroke recurrence 4-5 % per year. Despite recent scientific advances in acute ischemic stroke treatment in recent decades,consensus treatment of all guidelines is still ASA
This is an outcome assessor blind, randomized, parallel, placebo-controlled pilot study on ischemic stroke of undetermined source which will be conducted in Bu Ali Sina hospital in Sari, Iran. Patients with recent stroke with criteria of ESUS, will be randomized to Rivaroxaban 2.5 mg BID plus ASA 80 mg daily or ASA 80 mg plus placebo (1:1 ratio) and have visit every 3 month until 1 year
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
42
Tablet Rivaroxaban 2.5 mg 2 times daily add to standard treatment ASA 80 mg daily
Placebo tablets add to ASA 80 mg daily that is standard treatment
Bou- Ali Sina Hospital
Sari, Mazandaran, Iran
Rate of stroke recurrence
Number of stroke events during 1 year of study
Time frame: Rate of stroke recurrence during one year fallow up
Rate of major bleeding
Rate of major bleeding according to criteria of the International Society of Thrombosis and Hemostasis
Time frame: During 1 year of study
Rate of stroke or systemic embolisms
Number of stroke or systemic embolisms recurrence during 1 year of study
Time frame: During 1 year of study
Mortality rate
Number of all cause mortality during study
Time frame: During 1year of study
Rate of non-major bleeding
Rate of non-major bleeding according to criteria of the International Society of Thrombosis and Hemostasis
Time frame: During 1year of study
Rate of intracranial bleeding
Rate of ICH during study
Time frame: During 1year of study
Rate of fatal bleeding
Rate of fatal bleeding in any site
Time frame: During 1 year of study
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