Patient Convenience Study

NCT02597920 | Completed Results

• 1 other identifier: 1160.247
• Study Type: observational
• Target: 1,852
• Locations: 7 countries
• Sites: 148

Brief Summary

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).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (6)

• 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).

• 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).

• 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

• 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

• 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

• 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 Outcomes (2)

• Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment

  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

  Baseline

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

European patients with non valvular atrial fibrillation

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (148)

1160.247.1019 Boehringer Ingelheim Investigational Site

Braine-l'Alleud, Belgium

Location

1160.247.1001 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1160.247.1018 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1160.247.1020 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1160.247.1013 Boehringer Ingelheim Investigational Site

De Pinte, Belgium

Location

1160.247.1010 Boehringer Ingelheim Investigational Site

Dendermonde, Belgium

Location

1160.247.1011 Boehringer Ingelheim Investigational Site

Diest, Belgium

Location

1160.247.1014 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

1160.247.1007 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1160.247.1021 Boehringer Ingelheim Investigational Site

Lier, Belgium

Location

1160.247.1002 Boehringer Ingelheim Investigational Site

Maaseik, Belgium

Location

1160.247.1015 Boehringer Ingelheim Investigational Site

Meise, Belgium

Location

1160.247.1008 Boehringer Ingelheim Investigational Site

Mol, Belgium

Location

1160.247.1016 Boehringer Ingelheim Investigational Site

Mol, Belgium

Location

1160.247.1005 Boehringer Ingelheim Investigational Site

Mons, Belgium

Location

1160.247.1009 Boehringer Ingelheim Investigational Site

Nijlen, Belgium

Location

1160.247.1003 Boehringer Ingelheim Investigational Site

Ottignies-Louvain-la-Neuve, Belgium

Location

1160.247.1012 Boehringer Ingelheim Investigational Site

Roeselare, Belgium

Location

1160.247.1017 Boehringer Ingelheim Investigational Site

Tienen, Belgium

Location

1160.247.2006 Boehringer Ingelheim Investigational Site

Frederikssund, Denmark

Location

1160.247.2008 Boehringer Ingelheim Investigational Site

Herning, Denmark

Location

1160.247.2001 Sygehus Vendsyssel

Hjørring, Denmark

Location

1160.247.2007 Hvidovre Hospital

Hvidovre, Denmark

Location

1160.247.2005 Boehringer Ingelheim Investigational Site

Nykøbing Falster, Denmark

Location

1160.247.2003 Boehringer Ingelheim Investigational Site

Næstved, Denmark

Location

1160.247.2009 Boehringer Ingelheim Investigational Site

Roskilde, Denmark

Location

1160.247.2004 Boehringer Ingelheim Investigational Site

Svendborg, Denmark

Location

1160.247.3410 Boehringer Ingelheim Investigational Site

Agrinio, Greece

Location

1160.247.3306 Boehringer Ingelheim Investigational Site

Alexandroupoli, Greece

Location

1160.247.3411 Boehringer Ingelheim Investigational Site

Arta, Greece

Location

1160.247.3100 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3101 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3102 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3103 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3104 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3105 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3106 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3107 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3108 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3109 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3110 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3111 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3113 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3114 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3116 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3118 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3119 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3120 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3121 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3122 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3200 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3202 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3203 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3204 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3206 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3207 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3208 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3211 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3212 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3213 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3214 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3217 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3218 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.247.3316 Boehringer Ingelheim Investigational Site

Chalkidiki, Greece

Location

1160.247.3219 Boehringer Ingelheim Investigational Site

Chania, Greece

Location

1160.247.3404 Boehringer Ingelheim Investigational Site

Corfu, Greece

Location

1160.247.3315 Boehringer Ingelheim Investigational Site

Drama, Greece

Location

1160.247.3307 Boehringer Ingelheim Investigational Site

Giannitsá, Greece

Location

1160.247.3216 Boehringer Ingelheim Investigational Site

Glyfada, Athens, Greece

Location

1160.247.3215 Boehringer Ingelheim Investigational Site

Hrakleion ,Crete, Greece

Location

1160.247.3201 Boehringer Ingelheim Investigational Site

Ierapetra, Crete, Greece

Location

1160.247.3400 Boehringer Ingelheim Investigational Site

Ioannina, Greece

Location

1160.247.3408 Boehringer Ingelheim Investigational Site

Ioannina, Greece

Location

1160.247.3409 Boehringer Ingelheim Investigational Site

Ioannina, Greece

Location

1160.247.3402 Boehringer Ingelheim Investigational Site

Kalamata, Greece

Location

1160.247.3407 Boehringer Ingelheim Investigational Site

Karditsa, Greece

Location

1160.247.3318 Boehringer Ingelheim Investigational Site

Katerini, Greece

Location

1160.247.3312 Boehringer Ingelheim Investigational Site

Kavala, Greece

Location

1160.247.3320 V.Pavlou 21 , Komotini

Komotini, Greece

Location

1160.247.3415 Boehringer Ingelheim Investigational Site

Larissa, Greece

Location

1160.247.3412 Boehringer Ingelheim Investigational Site

Pátrai, Greece

Location

1160.247.3416 Boehringer Ingelheim Investigational Site

Pátrai, Greece

Location

1160.247.3317 Boehringer Ingelheim Investigational Site

Serres, Greece

Location

1160.247.3300 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

1160.247.3301 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

1160.247.3303 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

1160.247.3304 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

1160.247.3305 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

1160.247.3308 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

1160.247.3309 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

1160.247.3313 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

1160.247.3314 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

1160.247.3319 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

1160.247.3406 Boehringer Ingelheim Investigational Site

Trikala, Greece

Location

1160.247.3403 Boehringer Ingelheim Investigational Site

Tripoli, Greece

Location

1160.247.3310 Boehringer Ingelheim Investigational Site

Véroia, Greece

Location

1160.247.3401 Boehringer Ingelheim Investigational Site

Volos, Greece

Location

1160.247.3405 Boehringer Ingelheim Investigational Site

Xánthi, Greece

Location

1160.247.3413 Boehringer Ingelheim Investigational Site

Xilokastro, Greece

Location

1160.247.4004 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

1160.247.4010 Boehringer Ingelheim Investigational Site

Beugen, Netherlands

Location

1160.247.4013 Boehringer Ingelheim Investigational Site

Capelle aan den IJssel, Netherlands

Location

1160.247.4006 Boehringer Ingelheim Investigational Site

Ede, Netherlands

Location

1160.247.4009 Boehringer Ingelheim Investigational Site

Goes, Netherlands

Location

1160.247.4001 Boehringer Ingelheim Investigational Site

Groningen, Netherlands

Location

1160.247.4008 Boehringer Ingelheim Investigational Site

Heerenveen, Netherlands

Location

1160.247.4012 Boehringer Ingelheim Investigational Site

Heerlen, Netherlands

Location

1160.247.4005 Boehringer Ingelheim Investigational Site

Nijmegen, Netherlands

Location

1160.247.4011 Boehringer Ingelheim Investigational Site

Schiedam, Netherlands

Location

1160.247.4002 Boehringer Ingelheim Investigational Site

The Hague, Netherlands

Location

1160.247.4007 Boehringer Ingelheim Investigational Site

Uden, Netherlands

Location

1160.247.4003 Boehringer Ingelheim Investigational Site

Veldhoven, Netherlands

Location

1160.247.5001 Boehringer Ingelheim Investigational Site

Bergen, Norway

Location

1160.247.5007 Boehringer Ingelheim Investigational Site

Førde, Norway

Location

1160.247.5008 Boehringer Ingelheim Investigational Site

Lierskogen, Norway

Location

1160.247.5009 Boehringer Ingelheim Investigational Site

Nesbru, Norway

Location

1160.247.5004 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1160.247.5005 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1160.247.5010 Boehringer Ingelheim Investigational Site

Stavanger, Norway

Location

1160.247.5006 Boehringer Ingelheim Investigational Site

Svelvik, Norway

Location

1160.247.6003 Boehringer Ingelheim Investigational Site

Amadora, Portugal

Location

1160.247.6012 Boehringer Ingelheim Investigational Site

Angra do Heroísmo, Portugal

Location

1160.247.6007 Boehringer Ingelheim Investigational Site

Aveiro, Portugal

Location

1160.247.6004 Boehringer Ingelheim Investigational Site

Braga, Portugal

Location

1160.247.6006 Boehringer Ingelheim Investigational Site

Guimarães, Portugal

Location

1160.247.6013 Boehringer Ingelheim Investigational Site

Horta, Portugal

Location

1160.247.6002 Boehringer Ingelheim Investigational Site

Matosinhos Municipality, Portugal

Location

1160.247.6009 Boehringer Ingelheim Investigational Site

Penafiel, Portugal

Location

1160.247.6008 Boehringer Ingelheim Investigational Site

Viana do Castelo, Portugal

Location

1160.247.6005 Boehringer Ingelheim Investigational Site

Vila Franca de Xira, Portugal

Location

1160.247.7016 Boehringer Ingelheim Investigational Site

Bandhagen, Sweden

Location

1160.247.7013 Boehringer Ingelheim Investigational Site

Broby, Sweden

Location

1160.247.7006 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1160.247.7007 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1160.247.7014 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1160.247.7011 Boehringer Ingelheim Investigational Site

Hässleholm, Sweden

Location

1160.247.7019 Boehringer Ingelheim Investigational Site

Kristianstad, Sweden

Location

1160.247.7005 Boehringer Ingelheim Investigational Site

Malmo, Sweden

Location

1160.247.7001 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.247.7002 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.247.7003 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.247.7004 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.247.7008 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.247.7010 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.247.7012 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.247.7017 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.247.7009 Boehringer Ingelheim Investigational Site

Värnamo, Sweden

Location

1160.247.7015 Boehringer Ingelheim Investigational Site

Västerås, Sweden

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was conducted in an unblinded manner so site and patient selection bias could have occurred. Therefore, current practice patterns at these sites may not necessarily reflect patterns of care elsewhere.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 5, 2015
• Study Start: November 11, 2015
• Primary Completion: January 30, 2017
• Study Completion: January 30, 2017
• Last Updated: February 21, 2019
• Results First Posted: February 21, 2019

Record last verified: 2018-10

Locations

DK (8); NO (8); PT (10); GR (72); BE (19); NL (13); SE (18)