check_circleStudy Completed
Stroke, Embolism
Bayer Identifier:
16627
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Non-interventional local study on prescription behavior of anticoagulation therapy in secondary stroke prevention in atrial fibrillation patients
Trial purpose
This is local prospective multicenter observational non-interventional local study. Primary study objective is investigate and describe prescription pattern of neurologists in secondary stroke or non-CNS (non-Central Nervous System) systemic embolism prevention in patients with AF (Atrial fibrillation) and prior stroke or TIA (Transient Ischemic attack) who treat with rivaroxaban at an initial visit and three follow-up visits.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
209Trial Dates
July 2013 - July 2015Phase
N/ACould I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations, Russia |
Primary Outcome
- Prescription pattern of neurologists in secondary stroke or non-CNS systemic embolism prevention in patients with AF and prior stroke or TIA who treat with rivaroxaban- Time lag after prior stroke or TIA before Xarelto prescription; - Frequency of switching/discontinuation of Xarelto treatment; - Time to switching/discontinuation of Xarelto treatment; - Reasons of switching/discontinuation of Xarelto treatment (using formalized criteria list); - In case of change of treatment - drug, dose, duration of usedate_rangeTime Frame:up to 6 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Descriptive characteristics of patients after prior stroke/TIA in the need of secondary stroke prevention with Xarelto (gender, age, race, alcohol/smoking, BMI and BP abnormalities, CHA2DS2 VASC, HAS BLED, Rankin Score)CHA2DS2 VASC - Stroke risk assessment scale; HAS BLED - Score for Major Bleeding Risk (in anticoagulation therapy)date_rangeTime Frame:up to 6 monthsenhanced_encryptionNoSafety Issue:
- Identify time of start of anticoagulation therapy immediately after event (stroke or TIA) for secondary prevention in real life practicedate_rangeTime Frame:up to 6 monthsenhanced_encryptionNoSafety Issue:
- Describe AE characteristics (frequency, severity, relation to treatment, AE treatment, AE outcome)date_rangeTime Frame:up to 6 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
OtherTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A