Rivaroxaban Acute Stroke Safety Study

NCT02279940 | Completed

• 1 other identifier: Version 1.0
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke; Transient Ischemic Attack

Keywords

rivaroxaban; stroke; transient ischemic attack; ischemia

Outcome Measures

Primary Outcomes (1)

• Symptomatic Hemorrhagic Transformation Rate

  PH2 associated with clinical deterioration, defined as worsening of NIHSS score of 4 or more points within 30 days of initiating anticoagulant therapy

  30 days post-treatment

Secondary Outcomes (3)

• Any parenchymal haemorrhage (PH1 or PH2) on follow-up MRI scan at 7±2 days post-enrolment.

  7 days post-treatment

• Recurrent Transient Ischemic Attack/Ischemic Stroke within 90 days of enrolment.

  90 days following enrollment

• Systemic hemorrhagic complication rate within 90 days of enrolment.

  90 days following enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Bayer: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient; Stroke; Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: October 31, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2016
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

CA (1)