Patient Convenience Study (RE-SONANCE)
22. května 2019 aktualizováno: 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).
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Pozorovací
Zápis (Aktuální)
9472
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Multiple Locations, Bulharsko
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Multiple Locations, Estonsko
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Multiple Locations, Izrael
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Multiple Locations, Lotyšsko
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Multiple Locations, Maďarsko
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Multiple Locations, Polsko
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Multiple Locations, Rakousko
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Multiple Locations, Rumunsko
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Multiple Locations, Ruská Federace
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Multiple Locations, Slovinsko
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Multiple Locations, Srbsko
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Multiple Locations, Česko
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
European patients with non valvular atrial fibrillation
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Convenience PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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PACT-Q2 Scores at Last Assessment Compared to Second Assessment
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
11. listopadu 2015
Primární dokončení (Aktuální)
1. června 2017
Dokončení studie (Aktuální)
1. června 2017
Termíny zápisu do studia
První předloženo
11. listopadu 2015
První předloženo, které splnilo kritéria kontroly kvality
17. února 2016
První zveřejněno (Odhad)
18. února 2016
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
24. července 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
22. května 2019
Naposledy ověřeno
1. května 2019
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 1160.249
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