A Phase 2/3 interventional study of Rivaroxaban 2.5 Mg Oral Tablet and Rivaroxaban placebo tablets in Stroke and Prevention, sponsored by Mazandaran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by Mazandaran University of Medical Sciences · Phase 2/3, Interventional, and Prevention
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
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 42 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Mazandaran University of Medical Sciences is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
only one risk factors of potential embolic source including:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tablet Rivaroxaban 2.5 mg 2 times daily plus ASA 80 mg daily
Drug: Rivaroxaban 2.5 Mg Oral Tablet
Tab ASA 80 mg daily plus placebo ( similar to rivaroxaban tablet) 2 times daily
Drug: Rivaroxaban placebo tablets
Tablet Rivaroxaban 2.5 mg 2 times daily add to standard treatment ASA 80 mg daily
Also known as: Axabin 2.5
Placebo tablets add to ASA 80 mg daily that is standard treatment
Also known as: Placebo
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
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: Data will be available for researchers and scientific persons after request and review the proposal .
No publications or documents are linked to this record.
Ran from Aug 2020 to primary completion in Apr 2023, 31 months.
Of 27 phase 2/3 interventional studies under Stroke, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 77. This study's 31 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rivaroxaban
Mazandaran University of Medical Sciences