- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02684981
Patient Convenience Study (RE-SONANCE)
22 maja 2019 zaktualizowane przez: Boehringer Ingelheim
Non-interventional Study Describing Patients´ Perception on Anticoagulant Treatment and Treatment Convenience When Treated With Pradaxa or Vitamine K Antagonist for Stroke Prevention in Non-Valvular Atrial Fibrillation
The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 milligrams or 150 milligrams twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).
Przegląd badań
Status
Zakończony
Warunki
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
9472
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Multiple Locations, Austria
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Multiple Locations, Bułgaria
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Multiple Locations, Czechy
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Multiple Locations, Estonia
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Multiple Locations, Federacja Rosyjska
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Multiple Locations, Izrael
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Multiple Locations, Polska
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Multiple Locations, Rumunia
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Multiple Locations, Serbia
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Multiple Locations, Słowenia
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Multiple Locations, Węgry
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Multiple Locations, Łotwa
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
European patients with non valvular atrial fibrillation
Opis
Inclusion criteria:
Cohort A:
- A. Written informed consent prior to participation
- A. Female and male patients >= 18 years of age with a diagnosis of non-valvular atrial fibrillation.
- A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
- A. Patients switched to Pradaxa according Summary of Product Characteristics and physician's discretion.
OR
Cohort B:
- B. Written informed consent prior to participation.
- B. Female and male patients >= 18 years of age newly diagnosed with non-valvular atrial fibrillation and no previous treatment for stroke prevention (no use of any oral anticoagulant (OAC) within one year prior to enrolment).
- B. Stroke prevention treatment initiated with Pradaxa or VKA according to Summary of Product Characteristics and physician's discretion.
Exclusion criteria:
- Contraindication to the use of Pradaxa or VKA as described in the Summary of Product Characteristics (SmPC).
- Patients receiving Pradaxa or VKA for any other condition than stroke prevention in atrial fibrillation.
- Current participation in any clinical trial of a drug or device.
- Current participation in an European registry on the use of oral anticoagulation in AF.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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Cohort A - VKA to Pradaxa switcher
Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa.
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Cohort B - newly assigned to treatment
Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Convenience PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment
Ramy czasowe: From baseline up to 210 days
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The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction.
For each domain, a global score was calculated and used for analysis.
The range of the global score is 0-100, with higher score indicating better outcome.
The global score is calculated by summing up the individual scores, and then rescaled to 0-100.
The PACT-Q2 is to be administered to patients once treatment is ongoing.
Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
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From baseline up to 210 days
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Satisfaction PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment
Ramy czasowe: From baseline up to 210 days
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The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction.
For each domain, a global score was calculated and used for analysis.
The range of the global score is 0-100, with higher score indicating better outcome.
The global score is calculated by summing up the individual scores, and then rescaled to 0-100.
The PACT-Q2 is to be administered to patients once treatment is ongoing.
Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
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From baseline up to 210 days
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Convenience PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups
Ramy czasowe: Day 30 up to Day 210
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The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction.
For each domain, a global score was calculated and used for analysis.
The range of the global score is 0-100, with higher score indicating better outcome.
The global score is calculated by summing up the individual scores, and then rescaled to 0-100.
The PACT-Q2 is to be administered to patients once treatment is ongoing.
Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
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Day 30 up to Day 210
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Satisfaction PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups
Ramy czasowe: Day 30 up to Day 210
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The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction.
For each domain, a global score was calculated and used for analysis.
The range of the global score is 0-100, with higher score indicating better outcome.
The global score is calculated by summing up the individual scores, and then rescaled to 0-100.
The PACT-Q2 is to be administered to patients once treatment is ongoing.
Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
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Day 30 up to Day 210
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Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score
Ramy czasowe: Baseline
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CHA2DS2-VASc score, are clinical prediction rules for estimating the risk of stroke in patients with non-rheumatic atrial fibrillation (AF), a common and serious heart arrhythmia associated with thromboembolic stroke.
Such a score is used to determine whether or not treatment is required with anticoagulation therapy or antiplatelet therapy.
CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.
Score of < 2 was considered as low or intermediate risk and score of ≥ 2 was considered as high risk.
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Baseline
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Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score
Ramy czasowe: Baseline
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HAS-BLED is a scoring system developed to assess 1-year risk of major bleeding in patients with atrial fibrillation.
A calculated HAS-BLED score is between 0 and 9 and based on eight parameters with a weighted value of 0-2.
A high score corresponds to a greater risk, while low score corresponds to a lower risk.
Data presented are percentage of patients with high and low risk.
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Baseline
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Characterization of Patients With Respect to Kidney Function (Creatinine Clearance)
Ramy czasowe: Baseline and up to 210 days
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Creatinine is a waste product produced by muscles from the breakdown of a compound called creatine.
Creatinine is filtered from the blood by the kidneys and released into the urine.
A creatinine clearance test measures creatinine levels in both a sample of blood and a sample of urine from a 24-hour urine collection.
The results are used to calculate the amount of creatinine that has been cleared from the blood and passed into the urine.
Data presented here are geometric mean and confidence interval of creatinine clearance for patients at baseline (V1), initiation stage (V2) and continuation stage (V3).
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Baseline and up to 210 days
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Characterization of Patients With Respect to Comorbidities
Ramy czasowe: Baseline
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Comorbidity is the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder.
Data presented here are percentage of total patients with comorbidities.
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Baseline
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Characterization of Patients With Respect to Concomitant Therapies
Ramy czasowe: Baseline
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Concomitant therapies are two or more drugs used or given at or almost at the same time.
The data presented here are percentage of total patients for taking concomitant medication.
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Baseline
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Characterization of Patients With Respect to Dosing of Pradaxa
Ramy czasowe: Baseline and up to 210 days
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The data presented in this outcome measure is percentage of patients in both cohorts receiving 110 mg and 150 mg dose of Pradaxa at baseline (V1).
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Baseline and up to 210 days
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Duration in Months of Previous VKA Treatment
Ramy czasowe: Baseline
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The data presented in this outcome measure are Mean (SD) of duration in months of previous VKA treatment in total patients in cohort A.
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Baseline
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Stroke- and/or Bleeding Related Risk Factors in Medical History and at Baseline (Not Applicable)
Ramy czasowe: Baseline
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This endpoint is not assessable as the necessary data was not collected in the database
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Baseline
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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PACT-Q2 Scores at Last Assessment Compared to Second Assessment
Ramy czasowe: From 30 days up to 210 days
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The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction.
For each domain, a global score was calculated and used for analysis.
The range of the global score is 0-100, with higher score indicating better outcome.
The global score is calculated by summing up the individual scores, and then rescaled to 0-100.
Due to the non-normality of the data, results presented here are median change in PACT-Q2 scores between initiation stage (V2) and Continuation stage (V3).
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From 30 days up to 210 days
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Description of PACT-Q1 Items at Baseline
Ramy czasowe: Baseline
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Patients in Cohort B were given PACT-Q1 to assess patients' expectation from Anticoagulation therapy.
Following are the seven items from PACT-Q1.
The score range is 1-5.
Each question is analyzed individually, with higher score indicating better outcome.
A1 - How confident are you that your anticoagulant treatment (AT) will prevent blood clots?
A2 - Do you expect that your AT will relieve some of the symptoms you experience?
A3 - Do you expect that your AT will cause side effects such as minor bruises or bleeding?
A4 - How important is it for you to have an AT that is easy to take?
A5 - How concerned are you about making mistakes when taking your AT? A6 - How important is it for you to take care of your AT by yourself?
A7 - How concerned are you about how much you may have to pay for your AT?
For questions A1, A2, A4 and A6, higher score is higher expectations of the treatment and for questions A3, A5 and A7, lower score is higher expectations of the treatment.
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Baseline
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Współpracownicy i badacze
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Sponsor
Publikacje i pomocne linki
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Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
11 listopada 2015
Zakończenie podstawowe (Rzeczywisty)
1 czerwca 2017
Ukończenie studiów (Rzeczywisty)
1 czerwca 2017
Daty rejestracji na studia
Pierwszy przesłany
11 listopada 2015
Pierwszy przesłany, który spełnia kryteria kontroli jakości
17 lutego 2016
Pierwszy wysłany (Oszacować)
18 lutego 2016
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
24 lipca 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
22 maja 2019
Ostatnia weryfikacja
1 maja 2019
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 1160.249
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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