Rivaroxaban Acute Stroke Safety Study (RASS)
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ClinicalTrials.gov Identifier: NCT02279940 |
Recruitment Status :
Completed
First Posted : October 31, 2014
Last Update Posted : April 6, 2016
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Atrial fibrillation is a common cardiac arrhythmia and a major risk for ischemic stroke. Furthermore the risk of stroke is higher in the first month after transient ischemic attack (TIA)/stroke. Rivaroxaban has been approved by Health Canada over period of last two years for prevention of stroke and have been found equally effective as oral Vitamin K antagonist. The foremost benefits of NOAC are reduced intracranial bleeding risk and does not require coagulation monitoring.
Optimal timing of anticoagulation after TIA/stroke in patients with known non-valvular atrial fibrillation is not known. The practice is variable and opinion based. The bias for many stroke physicians and neurologists is to start later (after 1-2weeks) to prevent hemorrhagic transformation thus possibly exposing the patients to an increased risk of recurrence. The product monograph for the drug suggest to wait for variable of 3 to 14 days before starting the NOAC (Waiting period:14 days for dabigatran and rivaroxaban, 7 days for Apixaban after ischemic stroke and three days after TIA for rivaroxaban). The times have been chosen arbitrary.
The investigators aim to study incidence of symptomatic hemorrhage in patients with non-valvular atrial fibrillation who are initiated with new oral anticoagulants early after TIA and stroke.
Condition or disease |
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Acute Ischemic Stroke Transient Ischemic Attack |

Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 50 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 90 Days |
Official Title: | Rivaroxaban Acute Stroke Safety Study |
Study Start Date : | March 2014 |
Actual Primary Completion Date : | January 2016 |

- Symptomatic Hemorrhagic Transformation Rate [ Time Frame: 30 days post-treatment ]PH2 associated with clinical deterioration, defined as worsening of NIHSS score of 4 or more points within 30 days of initiating anticoagulant therapy
- Any parenchymal haemorrhage (PH1 or PH2) on follow-up MRI scan at 7±2 days post-enrolment. [ Time Frame: 7 days post-treatment ]
- Recurrent Transient Ischemic Attack/Ischemic Stroke within 90 days of enrolment. [ Time Frame: 90 days following enrollment ]
- Systemic hemorrhagic complication rate within 90 days of enrolment. [ Time Frame: 90 days following enrollment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- All patients will be ≥ 18 years of age.
- All patients will have a diagnosis of minor ischemic stroke, defined as NIHSS score ≤ 8, or Transient Ischemic Attack (TIA), defined as acute focal neurological deficits, with complete resolution of symptoms within 24 h of onset. In cases where onset time cannot be established, it will be considered to be the time when the patient was last known to be well.
- Atrial Fibrillation (AF, paroxysmal or persistent). AF must be confirmed with ECG/Holter monitor, or by history (clinical documentation of previous AF must be provided).
- All included patients will be prescribed rivaroxaban following their stroke/TIA.
Exclusion Criteria:
- Acute or chronic renal failure, defined as eGFR <30 ml/min (Cockcroft Gault formula).
- Known hypersensitivity to rivaroxaban.
- Prior treatment with rivaroxaban or any other novel oral anticoagulant (including all Factor Xa antagonists). Treatment with warfarin prior to the stroke/TIA is acceptable, but enrolment cannot begin until the INR is ≤2.0.
- Any significant ongoing systemic bleeding risk, i.e. active GI/GU bleeding or recent major surgery.
- Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
- Recent past history or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm. At the discretion of each Investigator.
- Hereditary or acquired haemorrhagic diathesis.
- Stroke mimics (such as seizures, migraine etc.)
- Contraindications to MRI will also be excluded, including metallic implants.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279940
Canada, Alberta | |
University of Alberta | |
Edmonton, Alberta, Canada, T6G 2B7 |
Responsible Party: | Ken Butcher, Assistant Professor, University of Alberta |
ClinicalTrials.gov Identifier: | NCT02279940 |
Other Study ID Numbers: |
Version 1.0 |
First Posted: | October 31, 2014 Key Record Dates |
Last Update Posted: | April 6, 2016 |
Last Verified: | April 2016 |
rivaroxaban stroke transient ischemic attack ischemia |
Stroke Ischemic Attack, Transient Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Ischemia |