ReAl-life Multicentre Survey Evaluating Stroke Prevention Strategies (RAMSES)
RAMSES
1 other identifier
observational
6,273
1 country
62
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2015
Shorter than P25 for all trials
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedSeptember 23, 2015
September 1, 2015
2 months
January 18, 2015
September 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of patients with non-valvular atrial fibrillation receiving appropriate oral anticoagulant for stroke prevention
2 months
Secondary Outcomes (4)
creatinine clearance of patients
2 months
time in therapeutic range of warfarin using patients
2 months
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
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
Study Arms (1)
atrial fibrillation patients
\>18 year old. Atrial fibrillation patients without mitral stenosis or any prosthesis.
Eligibility Criteria
Non-valvular atrial fibrillaiton patients
You may qualify if:
- Atrial fibrillation
You may not qualify if:
- Valvular heart disease (mitral stenosis, prosthetic heart valves, heart valve surgery)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
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)
Related Publications (6)
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.
PMID: 28407216DERIVEDBiteker 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.
PMID: 28394435DERIVEDBasaran 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.
PMID: 27848065DERIVEDBasaran 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.
PMID: 27723665DERIVEDBasaran 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.
PMID: 27583892DERIVEDBasaran 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.
PMID: 27138310DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Murat Biteker, Assoc. Prof.
Muğla Sıtkı Koçman University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
January 18, 2015
First Posted
January 26, 2015
Study Start
February 1, 2015
Primary Completion
April 1, 2015
Study Completion
May 1, 2015
Last Updated
September 23, 2015
Record last verified: 2015-09