ReAl-life Multicentre Survey Evaluating Stroke Prevention Strategies (RAMSES) (RAMSES)
September 22, 2015 updated by: Ozcan Basaran, Muğla Sıtkı Koçman University
ReAl-life Multicentre Survey Evaluating the Status of Stroke Prevention Strategies in Patients With Non-Valvular Atrial Fibrillation in TurKey (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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
6273
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Adana, Turkey
- Adana Numune Education and Research Hospital
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Ankara, Turkey
- Ankara Kecioren Education and Research Hospital
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Ankara, Turkey
- Diskapi Yidirim Beyazit Education and Research Hospital
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Ankara, Turkey
- Medicana International Ankara Hospital
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Ankara, Turkey
- Tobb Etü Hospital
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Ankara, Turkey
- UFUK UNIVERSITY FACULTY OF MEDICINE
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Antalya, Turkey
- Antalya Memorial Hospital
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Aydin, Turkey
- Aydin State Hospital
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Balikesir, Turkey
- Bandirma State Hospital
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Balikesir, Turkey
- Gönen State Hospital
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Batman, Turkey
- Batman State Hospital
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Bingol, Turkey
- Bingöl State Hospital
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Burdur, Turkey
- Burdur State Hospital
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Corum, Turkey
- Iskilip State Hospital
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Diyarbakir, Turkey
- Diyarbakir Gazi Yasargil Education and Research Hospital
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Elazig, Turkey
- Elazig Education and Research Hospital
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Erzurum, Turkey
- Erzurum Education and Research Hospital
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Eskisehir, Turkey
- Acibadem Eskisehir Hospital
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Gaziantep, Turkey
- Ersin Arslan State Hospital
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Gaziantep, Turkey
- Gaziantep 25 Aralik State Hospital
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Hatay, Turkey
- Hatay Iskenderun State Hospital
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Istanbul, Turkey
- Haydarpasa Numune Education and Research Hospital
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Istanbul, Turkey
- Acibadem Kadikoy Hospital
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Istanbul, Turkey
- Bagcilar Education and Research Hospital
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Istanbul, Turkey
- Istanbul Acibadem Maslak Hospital
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Istanbul, Turkey
- Istanbul Liv Hospital
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Istanbul, Turkey
- Istanbul Medipol University Medical Faculty
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Istanbul, Turkey
- Kartal Kosuyolu Education and Research Hospital
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Istanbul, Turkey
- Kartal Yavuz Selim State Hospital
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Istanbul, Turkey
- Sisli Etfal Education and Research Hospital
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Istanbul, Turkey
- Siyami Ersek Education and Research Hospital
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Istanbul, Turkey
- Sureyyapasa Education and Research Hospital
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Istanbul, Turkey
- Tuzla State Hospital
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Izmir, Turkey
- Izmir Medical Park Hospital
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Izmir, Turkey
- Gaziemir State Hospital
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Kahramanmaras, Turkey
- Kahramanmaras Necip Fazil Hospital
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Kars, Turkey
- Kafkas University Medical Faculty
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Kirklareli, Turkey
- Luleburgaz State Hospital
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Kocaeli, Turkey
- Gebze Fatih State Hospital
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Kocaeli, Turkey
- Kocaeli Derince Education and Research Hospital
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Kocaeli, Turkey
- Kocaeli State Hospital
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Konya, Turkey
- Mevlana University Faculty of Medicine
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Kutahya, Turkey
- DPU Evliya Celebi Education and Research Hsopital
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Malatya, Turkey
- Malatya State Hospital
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Mersin, Turkey
- Mersin University Medical Faculty
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Mersin, Turkey
- Mersin Dogus Hospital
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Mersin, Turkey
- Mersin State Hospital
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Mersin, Turkey
- Mersin Tarsus State Hospital
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Mersin, Turkey
- Mersin Toros State Hospital
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Mersin, Turkey
- Mut State Hospital
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Mugla, Turkey
- Fethiye State Hsopital
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Mugla, Turkey
- Mugla Sitki Kocman University Education and Research Hospital
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Samsun, Turkey
- Samsun Education and Research Hospital
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Samsun, Turkey
- Samsun Medical Park Hospital
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Sanliurfa, Turkey
- Sanliurfa Balikligol State Hospital
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Sanliurfa, Turkey
- Suruc State Hospital
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Sivas, Turkey
- Sivas Cumhuriyet University Medical Faculty
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Sivas, Turkey
- Sivas Numune State Hospital
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Tokat, Turkey
- Gaziosmanpasa University Medical Faculty
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Trabzon, Turkey
- Trabzon Ahi Evren Education and Research Hospital
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Usak, Turkey
- Usak State Hospital
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Yozgat, Turkey
- Yozgat State Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Non-valvular atrial fibrillaiton patients
Description
Inclusion Criteria:
- Atrial fibrillation
Exclusion Criteria:
- Valvular heart disease (mitral stenosis, prosthetic heart valves, heart valve surgery)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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atrial fibrillation patients
>18 year old.
Atrial fibrillation patients without mitral stenosis or any prosthesis.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The number of patients with non-valvular atrial fibrillation receiving appropriate oral anticoagulant for stroke prevention
Time Frame: 2 months
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2 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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creatinine clearance of patients
Time Frame: 2 months
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2 months
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time in therapeutic range of warfarin using patients
Time Frame: 2 months
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2 months
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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
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2 months
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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
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2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Murat Biteker, Assoc. Prof., Muğla Sıtkı Koçman University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mert KU, Mert GO, Basaran O, Beton O, Dogan V, Tekinalp M, Aykan AC, Kalaycioglu E, Bolat I, Tasar O, Safak O, Kalcik M, Yaman M, Kirma C, Biteker M; RAMSES investigators. Real-world stroke prevention strategies in nonvalvular atrial fibrillation in patients with renal impairment. Eur J Clin Invest. 2017 Jun;47(6):428-438. doi: 10.1111/eci.12758. Epub 2017 May 16.
- Biteker M, Basaran O, Dogan V, Altun I, Ozpamuk Karadeniz F, Tekkesin AI, Cakilli Y, Turkkan C, Hamidi M, Demir V, Gursoy MO, Tek Ozturk M, Aksan G, Seyis S, Balli M, Alici MH, Bozyel S. Real-World Clinical Characteristics and Treatment Patterns of Individuals Aged 80 and Older with Nonvalvular Atrial Fibrillation: Results from the ReAl-life Multicenter Survey Evaluating Stroke Study. J Am Geriatr Soc. 2017 Aug;65(8):1684-1690. doi: 10.1111/jgs.14855. Epub 2017 Apr 10.
- Basaran O, Dogan V, Beton O, Tekinalp M, Aykan AC, Kalaycioglu E, Bolat I, Tasar O, Safak O, Kalcik M, Yaman M, Inci S, Altintas B, Kalkan S, Kirma C, Biteker M; and Collaborators. Impact of valvular heart disease on oral anticoagulant therapy in non-valvular atrial fibrillation: results from the RAMSES study. J Thromb Thrombolysis. 2017 Feb;43(2):157-165. doi: 10.1007/s11239-016-1445-1.
- Basaran O, Beton O, Dogan V, Tekinalp M, Aykan AC, Kalaycioglu E, Bolat I, Tasar O, Safak O, Kalcik M, Yaman M, Altun I, Soylu MO, Kirma C, Biteker M; RAMSES Study. ReAl-life Multicenter Survey Evaluating Stroke prevention strategies in non-valvular atrial fibrillation (RAMSES study). Anatol J Cardiol. 2016 Oct;16(10):734-741. doi: 10.14744/AnatolJCardiol.2016.6752.
- Basaran O, Dogan V, Beton O, Tekinalp M, Aykan AC, Kalaycioglu E, Bolat I, Tasar O, Safak O, Kalcik M, Yaman M, Inci S, Altintas B, Kalkan S, Kirma C, Biteker M; and Collaborators. Suboptimal use of non-vitamin K antagonist oral anticoagulants: Results from the RAMSES study. Medicine (Baltimore). 2016 Aug;95(35):e4672. doi: 10.1097/MD.0000000000004672. Erratum In: Medicine (Baltimore). 2017 Feb 17;96(7):e6206.
- Basaran O, Dogan V, Memic Sancar K, Altun I, Mert KU, Mert GO, Basaran NF, Cekic EG, Kirma C, Biteker M; RAMSES investigators. Rationale, design and methodology of the RAMSES Study: ReAl-life Multicenter Survey Evaluating Stroke Prevention Strategies. Turk Kardiyol Dern Ars. 2016 Apr;44(3):215-20. doi: 10.5543/tkda.2015.29266.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
January 18, 2015
First Submitted That Met QC Criteria
January 22, 2015
First Posted (Estimate)
January 26, 2015
Study Record Updates
Last Update Posted (Estimate)
September 23, 2015
Last Update Submitted That Met QC Criteria
September 22, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAMSES
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