Rivaroxaban Acute Stroke Safety Study (RASS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02279940|
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : April 6, 2016
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|
|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 ]
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
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2B7|