Skip to main content
OpenTrials
Completed

NCT Number: NCT02344901

ReAl-life Multicentre Survey Evaluating Stroke Prevention Strategies (RAMSES)

The aim of this study is to evaluate the present status of stroke prevention strategies in patients with non-valvular atrial fibrillation (NVAF). Vitamin K antagonists (VKAs) have been the only available oral anticoagulant therapy for decades. Recently novel oral anticoagulants have emerged as an alternative for VKAs. This study is planned to evaluate the epidemiological characteristics, thromboembolic and bleeding risks, stroke prevention strategies and appropriateness of oral anticoagulant use in NVAF patients. Time in therapeutic range (TTR) is going to be calculated as the percent of visits in range (2-3) for warfarin patients. This is a national multicenter observational study in which Turkey is divided into seven regions. A proportional number of patients to the population of every region is planned to be included.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Adana Numune Education and Research Hospital, Adana, Turkey (Türkiye)

Loading trial locations.

About this study

Atrial fibrillation (AF), classified as nonvalvular (NVAF) in the absence of rheumatic mitral stenosis or valvular prosthesis,is the most common arrhythmia, with an estimated prevalence of 1.5-2%. AF is associated with a greater risk of arterial thromboembolic events, especially cerebrovascular, whose incidence is 5-7 times higher. The risk of death is also doubled, and AF has a greater degree of disability and probability of recurrence than stroke due to other causes. To prevent stroke in patients with NVAF, antithrombotic treatments are employed with oral anticoagulants such as vitamin K antagonists (VKA) and, in a number of circumstances, antiplatelet agents. Although VKA (mainly warfarin) are highly effective to reduce the risk of stroke, and have been the sole choice for stroke prevention during the last 50 years, their use is limited for a number of reasons: narrow therapeutic range, drug and food interactions, need for monitoring, and risk of bleeding. Recently, new oral anticoagulants (NOACs) have been marketed for this indication. The aim of this study was to determine the standard clinical practice followed in the treatment to prevent stroke in patients with NVAF in Turkey. The purpose of this study is to demonstrate the current status of the clinical background of AF patients and to follow, analyze and evaluate patients with AF in a large multicenter nation-wide trial. The primary inclusion criteria will be age ≥18 years and with electrocardiographically confirmed NVAF (eg, by electrocardiogram, Holter monitoring, etc). The enrollment of patients will be started in February 2014. All the participating institutions will enroll all consecutive patients with NVAF under regular outpatient care or under admission.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Atrial fibrillation

Exclusion criteria

  • Valvular heart disease (mitral stenosis, prosthetic heart valves, heart valve surgery)

Treatment and study plan

Primary outcomes

  1. The number of patients with non-valvular atrial fibrillation receiving appropriate oral anticoagulant for stroke prevention

    Time frame: 2 months

Secondary outcomes

  1. creatinine clearance of patients

    Time frame: 2 months

  2. time in therapeutic range of warfarin using patients

    Time frame: 2 months

  3. CHA2DS2VASc (congestive heart failure or left ventricular dysfunction, hypertension, age ≥75 years, diabetes, thromboembolism or stroke history, vascular disease, age 65-74 years, and sex) score of patients

    Time frame: 2 months

  4. HAS-BLED (hypertension, renal or liver failure, stroke history, bleeding history, labile international normalized ratio, age >65 years, drugs, or alcohol); score of patients

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

ReAl-life Multicentre Survey Evaluating the Status of Stroke Prevention Strategies in Patients With Non-Valvular Atrial Fibrillation in TurKey (RAMSES)

Acronym: RAMSES

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 26, 2015
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.