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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
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Ken Butcher, University of Alberta

Brief Summary:

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
Acute Ischemic Stroke Transient Ischemic Attack

  Show Detailed Description

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

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Any parenchymal haemorrhage (PH1 or PH2) on follow-up MRI scan at 7±2 days post-enrolment. [ Time Frame: 7 days post-treatment ]
  2. Recurrent Transient Ischemic Attack/Ischemic Stroke within 90 days of enrolment. [ Time Frame: 90 days following enrollment ]
  3. 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
Study Population
Consecutive patients with atrial fibrillation (new onset or previous history) with acute ischemic stroke or TIA will be screened from Emergency Department or stroke unit. A total of 50 male and female patients will be recruited within 24 hours of symptom onset. Informed consent will be obtained from the patient or substitute decision maker, in all cases prior to enrolment.
Criteria

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.

Information from the National Library of Medicine

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


Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Bayer

Responsible Party: Ken Butcher, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02279940     History of Changes
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

Keywords provided by Ken Butcher, University of Alberta:
rivaroxaban
stroke
transient ischemic attack
ischemia

Additional relevant MeSH terms:
Stroke
Ischemia
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants