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

NCT ID: NCT02344901

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6273 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-05-31

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.

Conditions

Thrombotic Stroke; Atrial Fibrillation and Flutter

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

atrial fibrillation patients

\>18 year old. Atrial fibrillation patients without mitral stenosis or any prosthesis.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Atrial fibrillation

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muğla Sıtkı Koçman University

OTHER

Sponsor Role: lead

Responsible Party

Ozcan Basaran

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murat Biteker, Assoc. Prof.

Role: STUDY_CHAIR

Muğla Sıtkı Koçman University

Locations

Adana Numune Education and Research Hospital

Adana, , Turkey (Türkiye)

Ankara Kecioren Education and Research Hospital

Ankara, , Turkey (Türkiye)

Diskapi Yidirim Beyazit Education and Research Hospital

Ankara, , Turkey (Türkiye)

Medicana International Ankara Hospital

Ankara, , Turkey (Türkiye)

TOBB ETU Hospital

Ankara, , Turkey (Türkiye)

Ufuk university Faculty of Medicine

Ankara, , Turkey (Türkiye)

Antalya Memorial Hospital

Antalya, , Turkey (Türkiye)

Aydin State Hospital

Aydin, , Turkey (Türkiye)

Bandirma State Hospital

Balıkesir, , Turkey (Türkiye)

Gonen State Hospital

Balıkesir, , Turkey (Türkiye)

Batman State Hospital

Batman, , Turkey (Türkiye)

Bingol State Hospital

Bingöl, , Turkey (Türkiye)

Burdur State Hospital

Burdur, , Turkey (Türkiye)

Iskilip State Hospital

Çorum, , Turkey (Türkiye)

Diyarbakir Gazi Yasargil Education and Research Hospital

Diyarbakır, , Turkey (Türkiye)

Elazig Education and Research Hospital

Elâzığ, , Turkey (Türkiye)

Erzurum Education and Research Hospital

Erzurum, , Turkey (Türkiye)

Acibadem Eskisehir Hospital

Eskişehir, , Turkey (Türkiye)

Ersin Arslan State Hospital

Gaziantep, , Turkey (Türkiye)

Gaziantep 25 Aralik State Hospital

Gaziantep, , Turkey (Türkiye)

Hatay Iskenderun State Hospital

Hatay, , Turkey (Türkiye)

Acibadem Kadikoy Hospital

Istanbul, , Turkey (Türkiye)

Bagcilar Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Haydarpasa Numune Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Istanbul Acibadem Maslak Hospital

Istanbul, , Turkey (Türkiye)

Istanbul Liv Hospital

Istanbul, , Turkey (Türkiye)

Istanbul Medipol University Medical Faculty

Istanbul, , Turkey (Türkiye)

Kartal Kosuyolu Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Kartal Yavuz Selim State Hospital

Istanbul, , Turkey (Türkiye)

Sisli Etfal Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Siyami Ersek Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Sureyyapasa Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Tuzla State Hospital

Istanbul, , Turkey (Türkiye)

Gaziemir State Hospital

Izmir, , Turkey (Türkiye)

Izmir Medical Park Hospital

Izmir, , Turkey (Türkiye)

Kahramanmaras Necip Fazil Hospital

Kahramanmaraş, , Turkey (Türkiye)

Kafkas University Medical Faculty

Kars, , Turkey (Türkiye)

Gebze Fatih State Hospital

Kocaeli, , Turkey (Türkiye)

Kocaeli Derince Education and Research Hospital

Kocaeli, , Turkey (Türkiye)

Kocaeli State Hospital

Kocaeli, , Turkey (Türkiye)

Mevlana University Faculty of Medicine

Konya, , Turkey (Türkiye)

DPU Evliya Celebi Education and Research Hsopital

Kütahya, , Turkey (Türkiye)

Luleburgaz State Hospital

Kırklareli, , Turkey (Türkiye)

Malatya State Hospital

Malatya, , Turkey (Türkiye)

Mersin Dogus Hospital

Mersin, , Turkey (Türkiye)

Mersin State Hospital

Mersin, , Turkey (Türkiye)

Mersin Tarsus State Hospital

Mersin, , Turkey (Türkiye)

Mersin Toros State Hospital

Mersin, , Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, , Turkey (Türkiye)

Mut State Hospital

Mersin, , Turkey (Türkiye)

Fethiye State Hsopital

Muğla, , Turkey (Türkiye)

Mugla Sitki Kocman University Education and Research Hospital

Muğla, , Turkey (Türkiye)

Samsun Education and Research Hospital

Samsun, , Turkey (Türkiye)

Samsun Medical Park Hospital

Samsun, , Turkey (Türkiye)

Sanliurfa Balikligol State Hospital

Sanliurfa, , Turkey (Türkiye)

Suruc State Hospital

Sanliurfa, , Turkey (Türkiye)

Sivas Cumhuriyet University Medical Faculty

Sivas, , Turkey (Türkiye)

Sivas Numune State Hospital

Sivas, , Turkey (Türkiye)

Gaziosmanpasa University Medical Faculty

Tokat Province, , Turkey (Türkiye)

Trabzon Ahi Evren Education and Research Hospital

Trabzon, , Turkey (Türkiye)

Usak State Hospital

Uşak, , Turkey (Türkiye)

Yozgat State Hospital

Yozgat, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 28407216 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28394435 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27848065 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27723665 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27583892 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27138310 (View on PubMed)

Other Identifiers

RAMSES

Identifier Type: -

Identifier Source: org_study_id