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Thrombotic StrokeRAMSESNCT02344901

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

An observational study of Thrombotic Stroke and Atrial Fibrillation and Flutter, run by Muğla Sıtkı Koçman University at 62 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
6,273 participants
Where
62 sitesTurkey (Türkiye)
Study dates
Feb 2015to May 2015
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Non-valvular atrial fibrillaiton patients

Who may be able to join

  • Atrial fibrillation

Who cannot join

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

Trial locations and contacts

62 sites in 1 country.

62 sites in 1 country

Turkey (Türkiye)62 sites

  • Adana Numune Education and Research Hospital

    Adana

  • Ankara Kecioren Education and Research Hospital

    Ankara

  • Diskapi Yidirim Beyazit Education and Research Hospital

    Ankara

  • Medicana International Ankara Hospital

    Ankara

  • TOBB ETU Hospital

    Ankara

  • Ufuk university Faculty of Medicine

    Ankara

  • Antalya Memorial Hospital

    Antalya

  • Aydin State Hospital

    Aydin

  • Bandirma State Hospital

    Balıkesir

  • Gonen State Hospital

    Balıkesir

  • Batman State Hospital

    Batman

  • Bingol State Hospital

    Bingoel

  • Burdur State Hospital

    Burdur

  • Iskilip State Hospital

    Çorum

  • Diyarbakir Gazi Yasargil Education and Research Hospital

    Diyarbakır

  • Elazig Education and Research Hospital

    Elâzığ

  • Erzurum Education and Research Hospital

    Erzurum

  • Acibadem Eskisehir Hospital

    Eskişehir

  • Ersin Arslan State Hospital

    Gaziantep

  • Gaziantep 25 Aralik State Hospital

    Gaziantep

  • Hatay Iskenderun State Hospital

    Hatay

  • Acibadem Kadikoy Hospital

    Istanbul

  • Bagcilar Education and Research Hospital

    Istanbul

  • Haydarpasa Numune Education and Research Hospital

    Istanbul

  • Istanbul Acibadem Maslak Hospital

    Istanbul

  • Istanbul Liv Hospital

    Istanbul

  • Istanbul Medipol University Medical Faculty

    Istanbul

  • Kartal Kosuyolu Education and Research Hospital

    Istanbul

  • Kartal Yavuz Selim State Hospital

    Istanbul

  • Sisli Etfal Education and Research Hospital

    Istanbul

  • Siyami Ersek Education and Research Hospital

    Istanbul

  • Sureyyapasa Education and Research Hospital

    Istanbul

  • Tuzla State Hospital

    Istanbul

  • Gaziemir State Hospital

    Izmir

  • Izmir Medical Park Hospital

    Izmir

  • Kahramanmaras Necip Fazil Hospital

    Kahramanmaraş

  • Kafkas University Medical Faculty

    Kars

  • Luleburgaz State Hospital

    Kırklareli

  • Gebze Fatih State Hospital

    Kocaeli

  • Kocaeli Derince Education and Research Hospital

    Kocaeli

  • Kocaeli State Hospital

    Kocaeli

  • Mevlana University Faculty of Medicine

    Konya

  • DPU Evliya Celebi Education and Research Hsopital

    Kütahya

  • Malatya State Hospital

    Malatya

  • Mersin Dogus Hospital

    Mersin

  • Mersin State Hospital

    Mersin

  • Mersin Tarsus State Hospital

    Mersin

  • Mersin Toros State Hospital

    Mersin

  • Mersin University Medical Faculty

    Mersin

  • Mut State Hospital

    Mersin

  • Fethiye State Hsopital

    Muğla

  • Mugla Sitki Kocman University Education and Research Hospital

    Muğla

  • Samsun Education and Research Hospital

    Samsun

  • Samsun Medical Park Hospital

    Samsun

  • Sanliurfa Balikligol State Hospital

    Sanliurfa

  • Suruc State Hospital

    Sanliurfa

  • Sivas Cumhuriyet University Medical Faculty

    Sivas

  • Sivas Numune State Hospital

    Sivas

  • Gaziosmanpasa University Medical Faculty

    Tokat Province

  • Trabzon Ahi Evren Education and Research Hospital

    Trabzon

  • Usak State Hospital

    Uşak

  • Yozgat State Hospital

    Yozgat

Other trials in Turkey (Türkiye)

About this study

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

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.

Keywords
non-valvular atrial fibrillation, stroke prevention, novel oral anticoagulants, warfarin
Medical subject headings
Thrombotic Stroke, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02344901
Study groupRoleWhat they receive
atrial fibrillation patients>18 year old. Atrial fibrillation patients without mitral stenosis or any prosthesis.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 2 months

Secondary outcomes (4)

  1. creatinine clearance of patients

    Measured: 2 months

  2. time in therapeutic range of warfarin using patients

    Measured: 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

    Measured: 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

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionApr 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
6,273 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT02344901
Sponsor's protocol ID
RAMSES
Acronym
RAMSES
Status last verified
Sep 2015
First submitted
18 Jan 2015
Last updated
23 Sep 2015
Results posted
No
Data monitoring committee
No

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.

    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

Questions about this trial

What is this clinical trial studying?

An observational study of Thrombotic Stroke and Atrial Fibrillation and Flutter, run by Muğla Sıtkı Koçman University at 62 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of patients with non-valvular atrial fibrillation receiving appropriate oral anticoagulant for stroke prevention (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02344901, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.

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