Patient Convenience Study (RE-SONANCE)
22 maggio 2019 aggiornato da: 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).
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Osservativo
Iscrizione (Effettivo)
9472
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Multiple Locations, Austria
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Multiple Locations, Bulgaria
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Multiple Locations, Cechia
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Multiple Locations, Estonia
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Multiple Locations, Federazione Russa
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Multiple Locations, Israele
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Multiple Locations, Lettonia
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Multiple Locations, Polonia
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Multiple Locations, Romania
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Multiple Locations, Serbia
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Multiple Locations, Slovenia
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Multiple Locations, Ungheria
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
European patients with non valvular atrial fibrillation
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Convenience PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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PACT-Q2 Scores at Last Assessment Compared to Second Assessment
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
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Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
11 novembre 2015
Completamento primario (Effettivo)
1 giugno 2017
Completamento dello studio (Effettivo)
1 giugno 2017
Date di iscrizione allo studio
Primo inviato
11 novembre 2015
Primo inviato che soddisfa i criteri di controllo qualità
17 febbraio 2016
Primo Inserito (Stima)
18 febbraio 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 luglio 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 maggio 2019
Ultimo verificato
1 maggio 2019
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1160.249
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .