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

September 22, 2015 updated by: Ozcan Basaran, Muğla Sıtkı Koçman University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6273

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey
        • Adana Numune Education and Research Hospital
      • Ankara, 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 Etü Hospital
      • Ankara, Turkey
        • UFUK UNIVERSITY FACULTY OF MEDICINE
      • Antalya, Turkey
        • Antalya Memorial Hospital
      • Aydin, Turkey
        • Aydin State Hospital
      • Balikesir, Turkey
        • Bandirma State Hospital
      • Balikesir, Turkey
        • Gönen State Hospital
      • Batman, Turkey
        • Batman State Hospital
      • Bingol, Turkey
        • Bingöl State Hospital
      • Burdur, Turkey
        • Burdur State Hospital
      • Corum, Turkey
        • Iskilip State Hospital
      • Diyarbakir, Turkey
        • Diyarbakir Gazi Yasargil Education and Research Hospital
      • Elazig, Turkey
        • Elazig Education and Research Hospital
      • Erzurum, Turkey
        • Erzurum Education and Research Hospital
      • Eskisehir, Turkey
        • Acibadem Eskisehir Hospital
      • Gaziantep, Turkey
        • Ersin Arslan State Hospital
      • Gaziantep, Turkey
        • Gaziantep 25 Aralik State Hospital
      • Hatay, Turkey
        • Hatay Iskenderun State Hospital
      • Istanbul, Turkey
        • Haydarpasa Numune Education and Research Hospital
      • Istanbul, Turkey
        • Acibadem Kadikoy Hospital
      • Istanbul, Turkey
        • Bagcilar 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
      • Izmir, Turkey
        • Izmir Medical Park Hospital
      • Izmir, Turkey
        • Gaziemir State Hospital
      • Kahramanmaras, Turkey
        • Kahramanmaras Necip Fazil Hospital
      • Kars, Turkey
        • Kafkas University Medical Faculty
      • Kirklareli, Turkey
        • Luleburgaz State Hospital
      • Kocaeli, Turkey
        • Gebze Fatih State Hospital
      • Kocaeli, Turkey
        • Kocaeli Derince Education and Research Hospital
      • Kocaeli, Turkey
        • Kocaeli State Hospital
      • Konya, Turkey
        • Mevlana University Faculty of Medicine
      • Kutahya, Turkey
        • DPU Evliya Celebi Education and Research Hsopital
      • Malatya, Turkey
        • Malatya State Hospital
      • Mersin, Turkey
        • Mersin University Medical Faculty
      • Mersin, Turkey
        • Mersin Dogus Hospital
      • Mersin, Turkey
        • Mersin State Hospital
      • Mersin, Turkey
        • Mersin Tarsus State Hospital
      • Mersin, Turkey
        • Mersin Toros State Hospital
      • Mersin, Turkey
        • Mut State Hospital
      • Mugla, Turkey
        • Fethiye State Hsopital
      • Mugla, Turkey
        • Mugla Sitki Kocman University Education and Research Hospital
      • Samsun, Turkey
        • Samsun Education and Research Hospital
      • Samsun, Turkey
        • Samsun Medical Park Hospital
      • Sanliurfa, Turkey
        • Sanliurfa Balikligol State Hospital
      • Sanliurfa, Turkey
        • Suruc State Hospital
      • Sivas, Turkey
        • Sivas Cumhuriyet University Medical Faculty
      • Sivas, Turkey
        • Sivas Numune State Hospital
      • Tokat, Turkey
        • Gaziosmanpasa University Medical Faculty
      • Trabzon, Turkey
        • Trabzon Ahi Evren Education and Research Hospital
      • Usak, Turkey
        • Usak State Hospital
      • Yozgat, Turkey
        • Yozgat State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Non-valvular atrial fibrillaiton patients

Description

Inclusion Criteria:

  • Atrial fibrillation

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
atrial fibrillation patients
>18 year old. Atrial fibrillation patients without mitral stenosis or any prosthesis.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The number of patients with non-valvular atrial fibrillation receiving appropriate oral anticoagulant for stroke prevention
Time Frame: 2 months
2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
creatinine clearance of patients
Time Frame: 2 months
2 months
time in therapeutic range of warfarin using patients
Time Frame: 2 months
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
Time Frame: 2 months
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
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Muğla Sıtkı Koçman University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Murat Biteker, Assoc. Prof., Muğla Sıtkı Koçman University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RAMSES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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