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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Tablet Rivaroxaban 2.5 mg 2 times daily plus ASA 80 mg daily |
|
| Comparator | Placebo Comparator | Tab ASA 80 mg daily plus placebo ( similar to rivaroxaban tablet) 2 times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 2.5 Mg Oral Tablet | Drug | Tablet Rivaroxaban 2.5 mg 2 times daily add to standard treatment ASA 80 mg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of stroke recurrence | Number of stroke events during 1 year of study | 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 | During 1 year of study |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of stroke or systemic embolisms | Number of stroke or systemic embolisms recurrence during 1 year of study | During 1 year of study |
| Mortality rate | Number of all cause mortality during study |
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Inclusion Criteria:
signing the inform consent
recent ischemic stroke ( 7-60) days with criteria of ESUS
only one risk factors of potential embolic source including:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Athena Sharifi-Razvi | mazandaran university of medical science | Principal Investigator |
| Monireh Ghazaeian | mazandaran university of medical science | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bou- Ali Sina Hospital | Sari | Mazandaran | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40037214 | Derived | Ghazaeian M, Ramzanpour F, Sharifi-Razavi A. Aspirin plus rivaroxaban efficacy and safety in embolic stroke of undetermined source: A randomized, placebo-controlled, outcome assessor-blind, feasibility study. Clin Neurol Neurosurg. 2025 Mar;250:108813. doi: 10.1016/j.clineuro.2025.108813. Epub 2025 Feb 28. |
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Data will be available for researchers and scientific persons after request and review the proposal .
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| Rivaroxaban placebo tablets | Drug | Placebo tablets add to ASA 80 mg daily that is standard treatment |
|
|
| 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 | During 1year of study |
| Rate of intracranial bleeding | Rate of ICH during study | During 1year of study |
| Rate of fatal bleeding | Rate of fatal bleeding in any site | During 1 year of study |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |