Clinical trial NCT02344901: ReAl-life Multicentre Survey Evaluating Stroke Prevention Strategies (RAMSES)
Official title: ReAl-life Multicentre Survey Evaluating the Status of Stroke Prevention Strategies in Patients With Non-Valvular Atrial Fibrillation in TurKey (RAMSES)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombotic Stroke
Atrial Fibrillation and Flutter
Keywords: non-valvular atrial fibrillation
stroke prevention
novel oral anticoagulants
warfarin
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 6273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-valvular atrial fibrillaiton patients

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Atrial fibrillation

Exclusion Criteria:

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

Primary outcomes:
measure: The number of patients with non-valvular atrial fibrillation receiving appropriate oral anticoagulant for stroke prevention
timeFrame: 2 months
Secondary outcomes:
measure: creatinine clearance of patients
timeFrame: 2 months
measure: time in therapeutic range of warfarin using patients
timeFrame: 2 months
measure: 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
timeFrame: 2 months
measure: HAS-BLED (hypertension, renal or liver failure, stroke history, bleeding history, labile international normalized ratio, age >65 years, drugs, or alcohol); score of patients
timeFrame: 2 months
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana Numune Education and Research Hospital
city: Ankara
country: Turkey
facility: Ankara Kecioren Education and Research Hospital
city: Ankara
country: Turkey
facility: Diskapi Yidirim Beyazit Education and Research Hospital
city: Ankara
country: Turkey
facility: Medicana International Ankara Hospital
city: Ankara
country: Turkey
facility: TOBB ETU Hospital
city: Ankara
country: Turkey
facility: Ufuk university Faculty of Medicine
city: Antalya
country: Turkey
facility: Antalya Memorial Hospital
city: Aydin
country: Turkey
facility: Aydin State Hospital
city: Balikesir
country: Turkey
facility: Bandirma State Hospital
city: Balikesir
country: Turkey
facility: Gonen State Hospital
city: Batman
country: Turkey
facility: Batman State Hospital
city: Bingol
country: Turkey
facility: Bingol State Hospital
city: Burdur
country: Turkey
facility: Burdur State Hospital
city: Corum
country: Turkey
facility: Iskilip State Hospital
city: Diyarbakir
country: Turkey
facility: Diyarbakir Gazi Yasargil Education and Research Hospital
city: Elazig
country: Turkey
facility: Elazig Education and Research Hospital
city: Erzurum
country: Turkey
facility: Erzurum Education and Research Hospital
city: Eskisehir
country: Turkey
facility: Acibadem Eskisehir Hospital
city: Gaziantep
country: Turkey
facility: Ersin Arslan State Hospital
city: Gaziantep
country: Turkey
facility: Gaziantep 25 Aralik State Hospital
city: Hatay
country: Turkey
facility: Hatay Iskenderun State Hospital
city: Istanbul
country: Turkey
facility: Acibadem Kadikoy Hospital
city: Istanbul
country: Turkey
facility: Bagcilar Education and Research Hospital
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Education and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul Acibadem Maslak Hospital
city: Istanbul
country: Turkey
facility: Istanbul Liv Hospital
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Medical Faculty
city: Istanbul
country: Turkey
facility: Kartal Kosuyolu Education and Research Hospital
city: Istanbul
country: Turkey
facility: Kartal Yavuz Selim State Hospital
city: Istanbul
country: Turkey
facility: Sisli Etfal Education and Research Hospital
city: Istanbul
country: Turkey
facility: Siyami Ersek Education and Research Hospital
city: Istanbul
country: Turkey
facility: Sureyyapasa Education and Research Hospital
city: Istanbul
country: Turkey
facility: Tuzla State Hospital
city: Izmir
country: Turkey
facility: Gaziemir State Hospital
city: Izmir
country: Turkey
facility: Izmir Medical Park Hospital
city: Kahramanmaras
country: Turkey
facility: Kahramanmaras Necip Fazil Hospital
city: Kars
country: Turkey
facility: Kafkas University Medical Faculty
city: Kirklareli
country: Turkey
facility: Luleburgaz State Hospital
city: Kocaeli
country: Turkey
facility: Gebze Fatih State Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli Derince Education and Research Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli State Hospital
city: Konya
country: Turkey
facility: Mevlana University Faculty of Medicine
city: Kutahya
country: Turkey
facility: DPU Evliya Celebi Education and Research Hsopital
city: Malatya
country: Turkey
facility: Malatya State Hospital
city: Mersin
country: Turkey
facility: Mersin Dogus Hospital
city: Mersin
country: Turkey
facility: Mersin State Hospital
city: Mersin
country: Turkey
facility: Mersin Tarsus State Hospital
city: Mersin
country: Turkey
facility: Mersin Toros State Hospital
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Mersin
country: Turkey
facility: Mut State Hospital
city: Mugla
country: Turkey
facility: Fethiye State Hsopital
city: Mugla
country: Turkey
facility: Mugla Sitki Kocman University Education and Research Hospital
city: Samsun
country: Turkey
facility: Samsun Education and Research Hospital
city: Samsun
country: Turkey
facility: Samsun Medical Park Hospital
city: Sanliurfa
country: Turkey
facility: Sanliurfa Balikligol State Hospital
city: Sanliurfa
country: Turkey
facility: Suruc State Hospital
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University Medical Faculty
city: Sivas
country: Turkey
facility: Sivas Numune State Hospital
city: Tokat
country: Turkey
facility: Gaziosmanpasa University Medical Faculty
city: Trabzon
country: Turkey
facility: Trabzon Ahi Evren Education and Research Hospital
city: Usak
country: Turkey
facility: Usak State Hospital
city: Yozgat
country: Turkey
facility: Yozgat State Hospital
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Murat Biteker, Assoc. Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.