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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02344901
Other study ID # RAMSES
Secondary ID
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


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
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