Protocol summary
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Study aim
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Efficacy and safety of rivaroxaban plus aspirin in reduce stroke recurrence in a patient with Embolic Stroke of Undetermined Source
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Design
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This is a randomized, parallel, placebo-controlled study on recent (7-60 days)ischemic stroke of undermine source.
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Settings and conduct
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Present study will be conducted in Buali hospitals in Sari.After meeting 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 have visit every three months until 1 year.
All adverse events, serious adverse events, outcome events will be recorded.
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Participants/Inclusion and exclusion criteria
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Adult patients with recent stroke and ESUS with one potential embolic risk but not high risk for bleeding events
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Intervention groups
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Patients in intervention group take ASA ( entric coated tablet) 80 mg once daily plus Rivaroxaban (film coated tablet)2.5 mg BID and patients in control group take ASA ( entric coated tablet) 80 mg once daily plus tab Placebo BID
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Main outcome variables
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The primary outcome is the rate and time of stroke or systemic embolism and major bleeding events according to the criteria of the International Society of Thrombosis and Hemostasis.
General information
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Reason for update
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the study design changed to" outcome assessor blind" because of placebo size difference
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200112046094N1
Registration date:
2020-08-14, 1399/05/24
Registration timing:
prospective
Last update:
2021-07-26, 1400/05/04
Update count:
1
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Registration date
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2020-08-14, 1399/05/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-08-22, 1399/06/01
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Expected recruitment end date
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2022-03-20, 1400/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Aspirin plus Rivaroxaban Efficacy and Safety in Embolic Stroke of Undetermined Source: A Randomized, Placebo Controlled, Outcome Assessor Blind, Clinical Trial
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Public title
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Rivaroxaban in Embolic Stroke of Undetermined Source(ESUS)
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Signing the informed consent
Recent ischemic stroke, with criteria of ESUS defined as: Stroke detected by CT or MRI that is not lacunar,Absence of extracranial or intracranial atherosclerosis causing ≥50% luminal stenosis in arteries supplying the area of ischemia, No major-risk cardioembolic source of embolism, No other specific cause of stroke identified
only one risk factor of potential embolic source including: PTFV1 in standard ECG ≥0.05 mm.s or ≥0.005 mv.s,LVH in standard ECG( Sokolow index≥ 35 mm), Moderate or severe MR, AR or AS in echocardiography , LVH in echocardiography, left atrium hypertrophy in echocardiography, PFO not candidate for closure
Exclusion criteria:
History of hypersensitivity to the investigational medicinal product
Indication for anticoagulation
Indication for dual antiplatelet therapy
Contraindication to investigational medications
History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
Gastrointestinal bleeding or major surgery within 3 months
Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months
HAS-BLED score > 3
Severe non-cardiovascular comorbidity with life expectancy < 3 months
Severe renal failure, defined as Glomerular Filtration Rate (GFR) <15ml/min, Dialysis, transplant, Cr >2.26 mg/dL
Severe hepatic insufficiency, Cirrhosis or Bilirubin >2x Normal or AST/ALT/AP >3x Normal
Modified Rankin Scale of >=4
Inability to swallow medications
Hemorrhagic transformation of infarction
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients are randomized in a 1:1 fashion to intervention or comparator group. A list of random numbers generated then by using a block randomization method with 4 block size, anonymized patient list encoded. The codes are written on an envelope and the group type (intervention or comparison) is placed on paper inside the envelope. These envelopes are stacked in order. At the time of enrollment of each patient who met the inclusion and exclusion criteria, the upper envelope is removed, and based on the code inside it, it is determined which group it belongs to.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Patient list concealed by statistics. Neurologist give drugs or placebo according to randomized code, neurology resident who assess patients outcome so is blind.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Secondary Ids
1
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Registry name
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clinicaltrial.gov
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Secondary trial Id
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NCT04273516
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Registration date
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2020-02-18, 1398/11/29
Ethics committees
1
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Ethics committee
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Approval date
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2020-07-08, 1399/04/18
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Ethics committee reference number
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IR.MAZUMS.REC.1399.454
Health conditions studied
1
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Description of health condition studied
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Ischemic Stroke
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ICD-10 code
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I63
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ICD-10 code description
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Cerebral infarction
Primary outcomes
1
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Description
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Rate of stroke or systemic embolism recur
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Timepoint
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12 months after drug administration
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Method of measurement
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recording in case report form
2
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Description
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Major bleeding events
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Timepoint
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12 month after drug administration
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Method of measurement
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recording in case report form based on International Society on Thrombosis and Haemostasis bleeding scale
Secondary outcomes
1
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Description
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all-cause mortality rate
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Timepoint
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at the end of 1 year
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Method of measurement
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recording in case report form
2
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Description
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non-major bleeding
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Timepoint
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at the end of 1 year
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Method of measurement
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recording in case report form
3
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Description
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fatal bleeding
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Timepoint
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at the end of 1 year
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Method of measurement
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record in case study form
Intervention groups
1
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Description
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Intervention group: ASA ( entric coated tablet) 80 mg once daily plus Rivaroxaban (film coated tablet)2.5 mg BID for 1 year
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Category
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Treatment - Drugs
2
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Description
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Control group: ASA ( enteric-coated tablet) 80 mg once daily plus placebo BID for 1 year. Placebo will be made in mazandarn university pharmacy school , similar to rivaroxaban.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mazandaran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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all unrecognizable data would be sharing
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When the data will become available and for how long
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6 month after result pblication
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To whom data/document is available
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Data will be available for researchers and scientific persons.
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Under which criteria data/document could be used
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If there is a similar published or documented proposal
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From where data/document is obtainable
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via email adders athena.sharifi@yahoo.com
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What processes are involved for a request to access data/document
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after request and review the proposal .It takes about 1 month.
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Comments
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