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CompletedNCT02344901RAMSESUpdated Sep 23, 2015

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

An observational study in Thrombotic Stroke and Atrial Fibrillation and Flutter, sponsored by Muğla Sıtkı Koçman University. Completed at 62 sites in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-23.

Sponsored by Muğla Sıtkı Koçman University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
6,273
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Thrombotic Stroke
  • Atrial Fibrillation and Flutter

Keywords

  • non-valvular atrial fibrillation
  • stroke prevention
  • novel oral anticoagulants
  • warfarin
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In context

Thrombotic Stroke

21 studies on the registry are indexed under Thrombotic Stroke; 8 are open to participants now.

Browse Thrombotic Stroke studies →

Lead sponsor

Muğla Sıtkı Koçman University is the lead sponsor of 114 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Non-valvular atrial fibrillaiton patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Atrial fibrillation

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
6,273 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • atrial fibrillation patients

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

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What researchers measure

Primary outcomes

  1. The number of patients with non-valvular atrial fibrillation receiving appropriate oral anticoagulant for stroke prevention

    Time frame: 2 months

Secondary outcomes

  1. creatinine clearance of patients

    Time frame: 2 months

  2. time in therapeutic range of warfarin using patients

    Time frame: 2 months

  3. 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

    Time frame: 2 months

  4. HAS-BLED (hypertension, renal or liver failure, stroke history, bleeding history, labile international normalized ratio, age >65 years, drugs, or alcohol); score of patients

    Time frame: 2 months

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Study locations

62 sites
  • 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, Turkey
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References and documents

Publications

  • 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. PubMed 28407216 ↗
  • 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. PubMed 28394435 ↗
  • 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. PubMed 27848065 ↗
  • 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. PubMed 27723665 ↗
  • 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. Erratum In: Medicine (Baltimore). 2017 Feb 17;96(7):e6206. doi: 10.1097/MD.0000000000006206. PubMed 27583892 ↗
  • 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. PubMed 27138310 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02344901
Responsible party
Ozcan Basaran (M.D., Muğla Sıtkı Koçman University) — Principal investigator
First posted
Jan 26, 2015
Start date
Feb 2015
Primary completion
Apr 2015
Completion
May 2015
Last update
Sep 23, 2015

Study contacts

Murat Biteker, Assoc. Prof.
study chair · Muğla Sıtkı Koçman University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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