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

Atrial Fibrillation and Flutter Clinical Trial

— RAMSES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344901
• Other study ID #: RAMSES
• Status: Completed
• Phase: N/A
• First received: January 18, 2015
• Last updated: September 22, 2015
• Start date: February 2015
• Est. completion date: May 2015

Study information

• Verified date: September 2015
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6273
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Atrial fibrillation

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation and Flutter
• Atrial Flutter
• Stroke
• Thrombotic Stroke

Locations

Country	Name	City	State
Turkey	Adana Numune Education and Research Hospital	Adana
Turkey	Ankara Kecioren Education and Research Hospital	Ankara
Turkey	Diskapi Yidirim Beyazit Education and Research Hospital	Ankara
Turkey	Medicana International Ankara Hospital	Ankara
Turkey	TOBB ETU Hospital	Ankara
Turkey	Ufuk university Faculty of Medicine	Ankara
Turkey	Antalya Memorial Hospital	Antalya
Turkey	Aydin State Hospital	Aydin
Turkey	Bandirma State Hospital	Balikesir
Turkey	Gonen State Hospital	Balikesir
Turkey	Batman State Hospital	Batman
Turkey	Bingol State Hospital	Bingol
Turkey	Burdur State Hospital	Burdur
Turkey	Iskilip State Hospital	Corum
Turkey	Diyarbakir Gazi Yasargil Education and Research Hospital	Diyarbakir
Turkey	Elazig Education and Research Hospital	Elazig
Turkey	Erzurum Education and Research Hospital	Erzurum
Turkey	Acibadem Eskisehir Hospital	Eskisehir
Turkey	Ersin Arslan State Hospital	Gaziantep
Turkey	Gaziantep 25 Aralik State Hospital	Gaziantep
Turkey	Hatay Iskenderun State Hospital	Hatay
Turkey	Acibadem Kadikoy Hospital	Istanbul
Turkey	Bagcilar Education and Research Hospital	Istanbul
Turkey	Haydarpasa Numune Education and Research Hospital	Istanbul
Turkey	Istanbul Acibadem Maslak Hospital	Istanbul
Turkey	Istanbul Liv Hospital	Istanbul
Turkey	Istanbul Medipol University Medical Faculty	Istanbul
Turkey	Kartal Kosuyolu Education and Research Hospital	Istanbul
Turkey	Kartal Yavuz Selim State Hospital	Istanbul
Turkey	Sisli Etfal Education and Research Hospital	Istanbul
Turkey	Siyami Ersek Education and Research Hospital	Istanbul
Turkey	Sureyyapasa Education and Research Hospital	Istanbul
Turkey	Tuzla State Hospital	Istanbul
Turkey	Gaziemir State Hospital	Izmir
Turkey	Izmir Medical Park Hospital	Izmir
Turkey	Kahramanmaras Necip Fazil Hospital	Kahramanmaras
Turkey	Kafkas University Medical Faculty	Kars
Turkey	Luleburgaz State Hospital	Kirklareli
Turkey	Gebze Fatih State Hospital	Kocaeli
Turkey	Kocaeli Derince Education and Research Hospital	Kocaeli
Turkey	Kocaeli State Hospital	Kocaeli
Turkey	Mevlana University Faculty of Medicine	Konya
Turkey	DPU Evliya Celebi Education and Research Hsopital	Kutahya
Turkey	Malatya State Hospital	Malatya
Turkey	Mersin Dogus Hospital	Mersin
Turkey	Mersin State Hospital	Mersin
Turkey	Mersin Tarsus State Hospital	Mersin
Turkey	Mersin Toros State Hospital	Mersin
Turkey	Mersin University Medical Faculty	Mersin
Turkey	Mut State Hospital	Mersin
Turkey	Fethiye State Hsopital	Mugla
Turkey	Mugla Sitki Kocman University Education and Research Hospital	Mugla
Turkey	Samsun Education and Research Hospital	Samsun
Turkey	Samsun Medical Park Hospital	Samsun
Turkey	Sanliurfa Balikligol State Hospital	Sanliurfa
Turkey	Suruc State Hospital	Sanliurfa
Turkey	Sivas Cumhuriyet University Medical Faculty	Sivas
Turkey	Sivas Numune State Hospital	Sivas
Turkey	Gaziosmanpasa University Medical Faculty	Tokat
Turkey	Trabzon Ahi Evren Education and Research Hospital	Trabzon
Turkey	Usak State Hospital	Usak
Turkey	Yozgat State Hospital	Yozgat

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients with non-valvular atrial fibrillation receiving appropriate oral anticoagulant for stroke prevention		2 months	No
Secondary	creatinine clearance of patients		2 months	No
Secondary	time in therapeutic range of warfarin using patients		2 months	No
Secondary	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		2 months	No
Secondary	HAS-BLED (hypertension, renal or liver failure, stroke history, bleeding history, labile international normalized ratio, age >65 years, drugs, or alcohol); score of patients		2 months	No