Atrial Fibrillation Clinical Trial
Official title:
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
| NCT number | NCT02597920 |
| Other study ID # | 1160.247 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 11, 2015 |
| Est. completion date | January 30, 2017 |
| Verified date | October 2018 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 1852 |
| Est. completion date | January 30, 2017 |
| Est. primary completion date | January 30, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | 1160.247.1019 Boehringer Ingelheim Investigational Site | Braine-l'Alleud | |
| Belgium | 1160.247.1018 Boehringer Ingelheim Investigational Site | Brussel | |
| Belgium | 1160.247.1020 Boehringer Ingelheim Investigational Site | Brussels | |
| Belgium | 1160.247.1001 Boehringer Ingelheim Investigational Site | Bruxelles | |
| Belgium | 1160.247.1013 Boehringer Ingelheim Investigational Site | De Pinte | |
| Belgium | 1160.247.1010 Boehringer Ingelheim Investigational Site | Dendermonde | |
| Belgium | 1160.247.1011 Boehringer Ingelheim Investigational Site | Diest | |
| Belgium | 1160.247.1014 Boehringer Ingelheim Investigational Site | Edegem | |
| Belgium | 1160.247.1007 Boehringer Ingelheim Investigational Site | Leuven | |
| Belgium | 1160.247.1021 Boehringer Ingelheim Investigational Site | Lier | |
| Belgium | 1160.247.1002 Boehringer Ingelheim Investigational Site | Maaseik | |
| Belgium | 1160.247.1015 Boehringer Ingelheim Investigational Site | Meise | |
| Belgium | 1160.247.1008 Boehringer Ingelheim Investigational Site | Mol | |
| Belgium | 1160.247.1016 Boehringer Ingelheim Investigational Site | Mol | |
| Belgium | 1160.247.1005 Boehringer Ingelheim Investigational Site | Mons | |
| Belgium | 1160.247.1009 Boehringer Ingelheim Investigational Site | Nijlen | |
| Belgium | 1160.247.1003 Boehringer Ingelheim Investigational Site | Ottignies - Louvain-la-neuve | |
| Belgium | 1160.247.1012 Boehringer Ingelheim Investigational Site | Roeselare | |
| Belgium | 1160.247.1017 Boehringer Ingelheim Investigational Site | Tienen | |
| Denmark | 1160.247.2006 Boehringer Ingelheim Investigational Site | Frederikssund | |
| Denmark | 1160.247.2008 Boehringer Ingelheim Investigational Site | Herning | |
| Denmark | 1160.247.2001 Sygehus Vendsyssel | Hjørring | |
| Denmark | 1160.247.2007 Hvidovre Hospital | Hvidovre | |
| Denmark | 1160.247.2003 Boehringer Ingelheim Investigational Site | Næstved | |
| Denmark | 1160.247.2005 Boehringer Ingelheim Investigational Site | Nykøbing F | |
| Denmark | 1160.247.2009 Boehringer Ingelheim Investigational Site | Roskilde | |
| Denmark | 1160.247.2004 Boehringer Ingelheim Investigational Site | Svendborg | |
| Greece | 1160.247.3410 Boehringer Ingelheim Investigational Site | Agrinio | |
| Greece | 1160.247.3306 Boehringer Ingelheim Investigational Site | Alexandroupoli | |
| Greece | 1160.247.3411 Boehringer Ingelheim Investigational Site | Arta | |
| Greece | 1160.247.3100 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3101 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3102 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3103 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3104 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3105 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3106 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3107 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3108 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3109 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3110 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3111 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3113 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3114 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3116 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3118 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3119 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3120 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3121 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3122 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3200 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3202 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3203 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3204 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3206 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3207 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3208 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3211 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3212 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3213 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3214 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3217 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3218 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1160.247.3316 Boehringer Ingelheim Investigational Site | Chalkidiki | |
| Greece | 1160.247.3219 Boehringer Ingelheim Investigational Site | Chania | |
| Greece | 1160.247.3315 Boehringer Ingelheim Investigational Site | Drama | |
| Greece | 1160.247.3307 Boehringer Ingelheim Investigational Site | Giannitsa | |
| Greece | 1160.247.3216 Boehringer Ingelheim Investigational Site | Glyfada, Athens | |
| Greece | 1160.247.3215 Boehringer Ingelheim Investigational Site | Hrakleion ,Crete | |
| Greece | 1160.247.3201 Boehringer Ingelheim Investigational Site | Ierapetra, Crete | |
| Greece | 1160.247.3400 Boehringer Ingelheim Investigational Site | Ioannina | |
| Greece | 1160.247.3408 Boehringer Ingelheim Investigational Site | Ioannina | |
| Greece | 1160.247.3409 Boehringer Ingelheim Investigational Site | Ioannina | |
| Greece | 1160.247.3402 Boehringer Ingelheim Investigational Site | Kalamata | |
| Greece | 1160.247.3407 Boehringer Ingelheim Investigational Site | Karditsa | |
| Greece | 1160.247.3318 Boehringer Ingelheim Investigational Site | Katerini | |
| Greece | 1160.247.3312 Boehringer Ingelheim Investigational Site | Kavala | |
| Greece | 1160.247.3404 Boehringer Ingelheim Investigational Site | Kerkyra | |
| Greece | 1160.247.3320 V.Pavlou 21 , Komotini | Komotini | |
| Greece | 1160.247.3415 Boehringer Ingelheim Investigational Site | Larissa | |
| Greece | 1160.247.3412 Boehringer Ingelheim Investigational Site | Patra | |
| Greece | 1160.247.3416 Boehringer Ingelheim Investigational Site | Patra | |
| Greece | 1160.247.3317 Boehringer Ingelheim Investigational Site | Serres | |
| Greece | 1160.247.3300 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| Greece | 1160.247.3301 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| Greece | 1160.247.3303 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| Greece | 1160.247.3304 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| Greece | 1160.247.3305 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| Greece | 1160.247.3308 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| Greece | 1160.247.3309 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| Greece | 1160.247.3313 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| Greece | 1160.247.3314 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| Greece | 1160.247.3319 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| Greece | 1160.247.3406 Boehringer Ingelheim Investigational Site | Trikala | |
| Greece | 1160.247.3403 Boehringer Ingelheim Investigational Site | Tripoli | |
| Greece | 1160.247.3310 Boehringer Ingelheim Investigational Site | Veroia | |
| Greece | 1160.247.3401 Boehringer Ingelheim Investigational Site | Volos | |
| Greece | 1160.247.3405 Boehringer Ingelheim Investigational Site | Xanthi | |
| Greece | 1160.247.3413 Boehringer Ingelheim Investigational Site | Xilokastro | |
| Netherlands | 1160.247.4004 Boehringer Ingelheim Investigational Site | Amsterdam | |
| Netherlands | 1160.247.4010 Boehringer Ingelheim Investigational Site | Beugen | |
| Netherlands | 1160.247.4013 Boehringer Ingelheim Investigational Site | Capelle A/d Ijssel | |
| Netherlands | 1160.247.4002 Boehringer Ingelheim Investigational Site | Den Haag | |
| Netherlands | 1160.247.4006 Boehringer Ingelheim Investigational Site | EDE | |
| Netherlands | 1160.247.4009 Boehringer Ingelheim Investigational Site | Goes | |
| Netherlands | 1160.247.4001 Boehringer Ingelheim Investigational Site | Groningen | |
| Netherlands | 1160.247.4008 Boehringer Ingelheim Investigational Site | Heerenveen | |
| Netherlands | 1160.247.4012 Boehringer Ingelheim Investigational Site | Heerlen | |
| Netherlands | 1160.247.4005 Boehringer Ingelheim Investigational Site | Nijmegen | |
| Netherlands | 1160.247.4011 Boehringer Ingelheim Investigational Site | Schiedam | |
| Netherlands | 1160.247.4007 Boehringer Ingelheim Investigational Site | Uden | |
| Netherlands | 1160.247.4003 Boehringer Ingelheim Investigational Site | Veldhoven | |
| Norway | 1160.247.5001 Boehringer Ingelheim Investigational Site | Bergen | |
| Norway | 1160.247.5007 Boehringer Ingelheim Investigational Site | Førde | |
| Norway | 1160.247.5008 Boehringer Ingelheim Investigational Site | Lierskogen | |
| Norway | 1160.247.5009 Boehringer Ingelheim Investigational Site | Nesbru | |
| Norway | 1160.247.5004 Boehringer Ingelheim Investigational Site | Oslo | |
| Norway | 1160.247.5005 Boehringer Ingelheim Investigational Site | Oslo | |
| Norway | 1160.247.5010 Boehringer Ingelheim Investigational Site | Stavanger | |
| Norway | 1160.247.5006 Boehringer Ingelheim Investigational Site | Svelvik | |
| Portugal | 1160.247.6003 Boehringer Ingelheim Investigational Site | Amadora | |
| Portugal | 1160.247.6012 Boehringer Ingelheim Investigational Site | Angra do Heroísmo | |
| Portugal | 1160.247.6007 Boehringer Ingelheim Investigational Site | Aveiro | |
| Portugal | 1160.247.6004 Boehringer Ingelheim Investigational Site | Braga | |
| Portugal | 1160.247.6006 Boehringer Ingelheim Investigational Site | Guimarães | |
| Portugal | 1160.247.6013 Boehringer Ingelheim Investigational Site | Horta | |
| Portugal | 1160.247.6002 Boehringer Ingelheim Investigational Site | Matosinhos | |
| Portugal | 1160.247.6009 Boehringer Ingelheim Investigational Site | Penafiel | |
| Portugal | 1160.247.6008 Boehringer Ingelheim Investigational Site | Viana do Castelo | |
| Portugal | 1160.247.6005 Boehringer Ingelheim Investigational Site | Vila Franca de Xira | |
| Sweden | 1160.247.7016 Boehringer Ingelheim Investigational Site | Bandhagen | |
| Sweden | 1160.247.7013 Boehringer Ingelheim Investigational Site | Broby | |
| Sweden | 1160.247.7006 Boehringer Ingelheim Investigational Site | Göteborg | |
| Sweden | 1160.247.7007 Boehringer Ingelheim Investigational Site | Göteborg | |
| Sweden | 1160.247.7014 Boehringer Ingelheim Investigational Site | Göteborg | |
| Sweden | 1160.247.7011 Boehringer Ingelheim Investigational Site | Hässleholm | |
| Sweden | 1160.247.7019 Boehringer Ingelheim Investigational Site | Kristianstad | |
| Sweden | 1160.247.7005 Boehringer Ingelheim Investigational Site | Malmö | |
| Sweden | 1160.247.7001 Boehringer Ingelheim Investigational Site | Stockholm | |
| Sweden | 1160.247.7002 Boehringer Ingelheim Investigational Site | Stockholm | |
| Sweden | 1160.247.7003 Boehringer Ingelheim Investigational Site | Stockholm | |
| Sweden | 1160.247.7004 Boehringer Ingelheim Investigational Site | Stockholm | |
| Sweden | 1160.247.7008 Boehringer Ingelheim Investigational Site | Stockholm | |
| Sweden | 1160.247.7010 Boehringer Ingelheim Investigational Site | Stockholm | |
| Sweden | 1160.247.7012 Boehringer Ingelheim Investigational Site | Stockholm | |
| Sweden | 1160.247.7017 Boehringer Ingelheim Investigational Site | Stockholm | |
| Sweden | 1160.247.7009 Boehringer Ingelheim Investigational Site | Värnamo | |
| Sweden | 1160.247.7015 Boehringer Ingelheim Investigational Site | Västerås |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Belgium, Denmark, Greece, Netherlands, Norway, Portugal, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | 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). | |
| Primary | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | 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). | |
| Primary | Patient Characterization at Baseline - Categorical Parameters | 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 | |
| Primary | Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score | 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 | |
| Primary | Patient Characterization at Baseline - Creatinine Clearance | Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics. | Baseline | |
| Primary | Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration | Vitamin K Antagonist (VKA) treatment duration at baseline is only applicable for Cohort A patients and is one of the baseline patient characteristics. | Baseline | |
| Secondary | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | 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). | |
| Secondary | Description of PACT-Q1 Items for Patients in Cohort B at 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 |
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