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

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ClinicalTrials.gov Identifier: NCT02344901
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
Ozcan Basaran, Muğla Sıtkı Koçman University

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.

Condition or disease
Thrombotic Stroke Atrial Fibrillation and Flutter

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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Study Type : Observational [Patient Registry]
Actual Enrollment : 6273 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: ReAl-life Multicentre Survey Evaluating the Status of Stroke Prevention Strategies in Patients With Non-Valvular Atrial Fibrillation in TurKey (RAMSES)
Study Start Date : February 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Group/Cohort
atrial fibrillation patients
>18 year old. Atrial fibrillation patients without mitral stenosis or any prosthesis.



Primary Outcome Measures :
  1. The number of patients with non-valvular atrial fibrillation receiving appropriate oral anticoagulant for stroke prevention [ Time Frame: 2 months ]

Secondary Outcome Measures :
  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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non-valvular atrial fibrillaiton patients
Criteria

Inclusion Criteria:

  • Atrial fibrillation

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344901


  Show 62 Study Locations
Sponsors and Collaborators
Muğla Sıtkı Koçman University
Investigators
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Study Chair: Murat Biteker, Assoc. Prof. Mugla Sitki Kocman University

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ozcan Basaran, M.D., Muğla Sıtkı Koçman University
ClinicalTrials.gov Identifier: NCT02344901     History of Changes
Other Study ID Numbers: RAMSES
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015
Keywords provided by Ozcan Basaran, Muğla Sıtkı Koçman University:
non-valvular atrial fibrillation
stroke prevention
novel oral anticoagulants
warfarin
Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes