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Patient Convenience Study

8. října 2018 aktualizováno: Boehringer Ingelheim

Non-interventional Study Describing Patients' Perception on Anticoagulant Treatment and Treatment Convenience When Treated With Pradaxa or Vitamin K Antagonist for Stroke Prophylaxis in 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 mg or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).

Přehled studie

Postavení

Dokončeno

Podmínky

Typ studie

Pozorovací

Zápis (Aktuální)

1852

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Belgie
      • Braine-l'Alleud, Belgie
        • 1160.247.1019 Boehringer Ingelheim Investigational Site
      • Brussel, Belgie
        • 1160.247.1018 Boehringer Ingelheim Investigational Site
      • Brussels, Belgie
        • 1160.247.1020 Boehringer Ingelheim Investigational Site
      • Bruxelles, Belgie
        • 1160.247.1001 Boehringer Ingelheim Investigational Site
      • De Pinte, Belgie
        • 1160.247.1013 Boehringer Ingelheim Investigational Site
      • Dendermonde, Belgie
        • 1160.247.1010 Boehringer Ingelheim Investigational Site
      • Diest, Belgie
        • 1160.247.1011 Boehringer Ingelheim Investigational Site
      • Edegem, Belgie
        • 1160.247.1014 Boehringer Ingelheim Investigational Site
      • Leuven, Belgie
        • 1160.247.1007 Boehringer Ingelheim Investigational Site
      • Lier, Belgie
        • 1160.247.1021 Boehringer Ingelheim Investigational Site
      • Maaseik, Belgie
        • 1160.247.1002 Boehringer Ingelheim Investigational Site
      • Meise, Belgie
        • 1160.247.1015 Boehringer Ingelheim Investigational Site
      • Mol, Belgie
        • 1160.247.1008 Boehringer Ingelheim Investigational Site
      • Mol, Belgie
        • 1160.247.1016 Boehringer Ingelheim Investigational Site
      • Mons, Belgie
        • 1160.247.1005 Boehringer Ingelheim Investigational Site
      • Nijlen, Belgie
        • 1160.247.1009 Boehringer Ingelheim Investigational Site
      • Ottignies - Louvain-la-neuve, Belgie
        • 1160.247.1003 Boehringer Ingelheim Investigational Site
      • Roeselare, Belgie
        • 1160.247.1012 Boehringer Ingelheim Investigational Site
      • Tienen, Belgie
        • 1160.247.1017 Boehringer Ingelheim Investigational Site
  • Dánsko
      • Frederikssund, Dánsko
        • 1160.247.2006 Boehringer Ingelheim Investigational Site
      • Herning, Dánsko
        • 1160.247.2008 Boehringer Ingelheim Investigational Site
      • Hjørring, Dánsko
        • 1160.247.2001 Sygehus Vendsyssel
      • Hvidovre, Dánsko
        • 1160.247.2007 Hvidovre Hospital
      • Nykøbing F, Dánsko
        • 1160.247.2005 Boehringer Ingelheim Investigational Site
      • Næstved, Dánsko
        • 1160.247.2003 Boehringer Ingelheim Investigational Site
      • Roskilde, Dánsko
        • 1160.247.2009 Boehringer Ingelheim Investigational Site
      • Svendborg, Dánsko
        • 1160.247.2004 Boehringer Ingelheim Investigational Site
  • Holandsko
      • Amsterdam, Holandsko
        • 1160.247.4004 Boehringer Ingelheim Investigational Site
      • Beugen, Holandsko
        • 1160.247.4010 Boehringer Ingelheim Investigational Site
      • Capelle A/d Ijssel, Holandsko
        • 1160.247.4013 Boehringer Ingelheim Investigational Site
      • Den Haag, Holandsko
        • 1160.247.4002 Boehringer Ingelheim Investigational Site
      • EDE, Holandsko
        • 1160.247.4006 Boehringer Ingelheim Investigational Site
      • Goes, Holandsko
        • 1160.247.4009 Boehringer Ingelheim Investigational Site
      • Groningen, Holandsko
        • 1160.247.4001 Boehringer Ingelheim Investigational Site
      • Heerenveen, Holandsko
        • 1160.247.4008 Boehringer Ingelheim Investigational Site
      • Heerlen, Holandsko
        • 1160.247.4012 Boehringer Ingelheim Investigational Site
      • Nijmegen, Holandsko
        • 1160.247.4005 Boehringer Ingelheim Investigational Site
      • Schiedam, Holandsko
        • 1160.247.4011 Boehringer Ingelheim Investigational Site
      • Uden, Holandsko
        • 1160.247.4007 Boehringer Ingelheim Investigational Site
      • Veldhoven, Holandsko
        • 1160.247.4003 Boehringer Ingelheim Investigational Site
  • Norsko
      • Bergen, Norsko
        • 1160.247.5001 Boehringer Ingelheim Investigational Site
      • Førde, Norsko
        • 1160.247.5007 Boehringer Ingelheim Investigational Site
      • Lierskogen, Norsko
        • 1160.247.5008 Boehringer Ingelheim Investigational Site
      • Nesbru, Norsko
        • 1160.247.5009 Boehringer Ingelheim Investigational Site
      • Oslo, Norsko
        • 1160.247.5004 Boehringer Ingelheim Investigational Site
      • Oslo, Norsko
        • 1160.247.5005 Boehringer Ingelheim Investigational Site
      • Stavanger, Norsko
        • 1160.247.5010 Boehringer Ingelheim Investigational Site
      • Svelvik, Norsko
        • 1160.247.5006 Boehringer Ingelheim Investigational Site
  • Portugalsko
      • Amadora, Portugalsko
        • 1160.247.6003 Boehringer Ingelheim Investigational Site
      • Angra do Heroísmo, Portugalsko
        • 1160.247.6012 Boehringer Ingelheim Investigational Site
      • Aveiro, Portugalsko
        • 1160.247.6007 Boehringer Ingelheim Investigational Site
      • Braga, Portugalsko
        • 1160.247.6004 Boehringer Ingelheim Investigational Site
      • Guimarães, Portugalsko
        • 1160.247.6006 Boehringer Ingelheim Investigational Site
      • Horta, Portugalsko
        • 1160.247.6013 Boehringer Ingelheim Investigational Site
      • Matosinhos, Portugalsko
        • 1160.247.6002 Boehringer Ingelheim Investigational Site
      • Penafiel, Portugalsko
        • 1160.247.6009 Boehringer Ingelheim Investigational Site
      • Viana do Castelo, Portugalsko
        • 1160.247.6008 Boehringer Ingelheim Investigational Site
      • Vila Franca de Xira, Portugalsko
        • 1160.247.6005 Boehringer Ingelheim Investigational Site
  • Řecko
      • Agrinio, Řecko
        • 1160.247.3410 Boehringer Ingelheim Investigational Site
      • Alexandroupoli, Řecko
        • 1160.247.3306 Boehringer Ingelheim Investigational Site
      • Arta, Řecko
        • 1160.247.3411 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3100 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3101 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3102 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3103 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3104 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3105 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3106 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3107 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3108 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3109 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3110 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3111 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3113 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3114 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3116 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3118 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3119 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3120 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3121 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3122 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3200 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3202 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3203 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3204 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3206 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3207 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3208 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3211 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3212 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3213 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3214 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3217 Boehringer Ingelheim Investigational Site
      • Athens, Řecko
        • 1160.247.3218 Boehringer Ingelheim Investigational Site
      • Chalkidiki, Řecko
        • 1160.247.3316 Boehringer Ingelheim Investigational Site
      • Chania, Řecko
        • 1160.247.3219 Boehringer Ingelheim Investigational Site
      • Drama, Řecko
        • 1160.247.3315 Boehringer Ingelheim Investigational Site
      • Giannitsa, Řecko
        • 1160.247.3307 Boehringer Ingelheim Investigational Site
      • Glyfada, Athens, Řecko
        • 1160.247.3216 Boehringer Ingelheim Investigational Site
      • Hrakleion ,Crete, Řecko
        • 1160.247.3215 Boehringer Ingelheim Investigational Site
      • Ierapetra, Crete, Řecko
        • 1160.247.3201 Boehringer Ingelheim Investigational Site
      • Ioannina, Řecko
        • 1160.247.3400 Boehringer Ingelheim Investigational Site
      • Ioannina, Řecko
        • 1160.247.3408 Boehringer Ingelheim Investigational Site
      • Ioannina, Řecko
        • 1160.247.3409 Boehringer Ingelheim Investigational Site
      • Kalamata, Řecko
        • 1160.247.3402 Boehringer Ingelheim Investigational Site
      • Karditsa, Řecko
        • 1160.247.3407 Boehringer Ingelheim Investigational Site
      • Katerini, Řecko
        • 1160.247.3318 Boehringer Ingelheim Investigational Site
      • Kavala, Řecko
        • 1160.247.3312 Boehringer Ingelheim Investigational Site
      • Kerkyra, Řecko
        • 1160.247.3404 Boehringer Ingelheim Investigational Site
      • Komotini, Řecko
        • 1160.247.3320 V.Pavlou 21 , Komotini
      • Larissa, Řecko
        • 1160.247.3415 Boehringer Ingelheim Investigational Site
      • Patra, Řecko
        • 1160.247.3412 Boehringer Ingelheim Investigational Site
      • Patra, Řecko
        • 1160.247.3416 Boehringer Ingelheim Investigational Site
      • Serres, Řecko
        • 1160.247.3317 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Řecko
        • 1160.247.3300 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Řecko
        • 1160.247.3301 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Řecko
        • 1160.247.3303 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Řecko
        • 1160.247.3304 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Řecko
        • 1160.247.3305 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Řecko
        • 1160.247.3308 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Řecko
        • 1160.247.3309 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Řecko
        • 1160.247.3313 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Řecko
        • 1160.247.3314 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Řecko
        • 1160.247.3319 Boehringer Ingelheim Investigational Site
      • Trikala, Řecko
        • 1160.247.3406 Boehringer Ingelheim Investigational Site
      • Tripoli, Řecko
        • 1160.247.3403 Boehringer Ingelheim Investigational Site
      • Veroia, Řecko
        • 1160.247.3310 Boehringer Ingelheim Investigational Site
      • Volos, Řecko
        • 1160.247.3401 Boehringer Ingelheim Investigational Site
      • Xanthi, Řecko
        • 1160.247.3405 Boehringer Ingelheim Investigational Site
      • Xilokastro, Řecko
        • 1160.247.3413 Boehringer Ingelheim Investigational Site
  • Švédsko
      • Bandhagen, Švédsko
        • 1160.247.7016 Boehringer Ingelheim Investigational Site
      • Broby, Švédsko
        • 1160.247.7013 Boehringer Ingelheim Investigational Site
      • Göteborg, Švédsko
        • 1160.247.7006 Boehringer Ingelheim Investigational Site
      • Göteborg, Švédsko
        • 1160.247.7007 Boehringer Ingelheim Investigational Site
      • Göteborg, Švédsko
        • 1160.247.7014 Boehringer Ingelheim Investigational Site
      • Hässleholm, Švédsko
        • 1160.247.7011 Boehringer Ingelheim Investigational Site
      • Kristianstad, Švédsko
        • 1160.247.7019 Boehringer Ingelheim Investigational Site
      • Malmö, Švédsko
        • 1160.247.7005 Boehringer Ingelheim Investigational Site
      • Stockholm, Švédsko
        • 1160.247.7001 Boehringer Ingelheim Investigational Site
      • Stockholm, Švédsko
        • 1160.247.7002 Boehringer Ingelheim Investigational Site
      • Stockholm, Švédsko
        • 1160.247.7003 Boehringer Ingelheim Investigational Site
      • Stockholm, Švédsko
        • 1160.247.7004 Boehringer Ingelheim Investigational Site
      • Stockholm, Švédsko
        • 1160.247.7008 Boehringer Ingelheim Investigational Site
      • Stockholm, Švédsko
        • 1160.247.7010 Boehringer Ingelheim Investigational Site
      • Stockholm, Švédsko
        • 1160.247.7012 Boehringer Ingelheim Investigational Site
      • Stockholm, Švédsko
        • 1160.247.7017 Boehringer Ingelheim Investigational Site
      • Värnamo, Švédsko
        • 1160.247.7009 Boehringer Ingelheim Investigational Site
      • Västerås, Švédsko
        • 1160.247.7015 Boehringer Ingelheim Investigational Site

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:

  1. A. Written informed consent prior to participation
  2. A. Female and male patients >= 18 years of age with a diagnosis of non-valvular atrial fibrillation.
  3. A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
  4. A. Patients switched to Pradaxa® according Summary of Product Characteristics and physician's discretion.

OR

Cohort B:

  1. B. Written informed consent prior to participation.
  2. 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).
  3. B. Stroke prevention treatment initiated with Pradaxa® or VKA according to Summary of Product Characteristics and physician's discretion.

Exclusion criteria:

  1. Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC).
  2. Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in atrial fibrillation.
  3. Current participation in any clinical trial of a drug or device.
  4. 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

  • Observační modely: Kohorta
  • Časové perspektivy: Budoucí

Kohorty a intervence

Skupina / kohorta
Switch patients / A
Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa.
New AF patients / B
Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
Časové okno: Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
The PACT-Q is a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores are more favorable. The two dimension scores are presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).
Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
Časové okno: Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching method is used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group are summarized and used for comparison.
Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
Patient Characterization at Baseline - Categorical Parameters
Časové okno: Baseline
Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history and at baseline (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).
Baseline
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score
Časové okno: Baseline
CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. CHA2DS2-VASc stroke risk score and HAS-BLED bleeding risk score at baseline are patient characteristics.
Baseline
Patient Characterization at Baseline - Creatinine Clearance
Časové okno: Baseline
Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.
Baseline
Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration
Časové okno: Baseline
Vitamin K Antagonist (VKA) treatment duration at baseline is only applicable for Cohort A patients and is one of the baseline patient characteristics.
Baseline

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
Časové okno: Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).
Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
Časové okno: Baseline
The PACT-Q1 is composed of a single dimension (7 items), covering the expectations of patients regarding their anticoagulant treatment, and was to be administered before treatment initiation. The 7 items are: A1: How confident are you that your anticoagulant treatment will prevent blood clots? A2: Do you expect that your anticoagulant treatment will relieve some of the symptoms you experience? A3: Do you expect that your anticoagulant treatment will cause side effects such as minor bruises or bleeding? A4: How important is it for you to have an anticoagulant treatment that is easy to take? A5: How concerned are you about making mistakes when taking your anticoagulant treatment? A6: How important is it for you to take care of your anticoagulant treatment by yourself? A7: How concerned are you about how much you pay for your anticoagulant treatment? Responses ranged from 1 (Not at all) to 5 (Extremely/ Completely/ Very much).
Baseline

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Boehringer Ingelheim

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)

30. ledna 2017

Dokončení studie (Aktuální)

30. ledna 2017

Termíny zápisu do studia

První předloženo

4. listopadu 2015

První předloženo, které splnilo kritéria kontroly kvality

4. listopadu 2015

První zveřejněno (Odhad)

5. listopadu 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. února 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. října 2018

Naposledy ověřeno

1. října 2018

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 1160.247

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Fibrilace síní

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Podmínky

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Drogové intervence

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Sponzor / Spolupracovníci

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