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Patient Convenience Study- NIS RELATE

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ClinicalTrials.gov Identifier: NCT02849509
Recruitment Status : Completed
First Posted : July 29, 2016
Results First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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).

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Pradaxa (dabigatran) Drug: Vitamin K antagonist

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Study Type : Observational
Actual Enrollment : 1313 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : June 20, 2016
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : December 30, 2017


Group/Cohort Intervention/treatment
Switch Patients / A
Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa.
Drug: Pradaxa (dabigatran)
Pradaxa (dabigatran etexilate)110mg or 150mg

New Patients / B
Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).
Drug: Vitamin K antagonist
Vitamin K antagonist or Pradaxa




Primary Outcome Measures :
  1. Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment [ Time Frame: Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA) ]

    Mean Perception of Anticoagulant treatment Questionnaire, part 2 (PACT-Q2) scores, for patients in cohort A, at second assessment compared to baseline assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease & treatment (2 items), & anticoagulant treatment satisfaction (7 items). In this outcome the mean convenience & satisfaction dimension scores of PACT-Q2 at second assessment (Visit 2) were compared with baseline assessment (Visit 1). Within the PACT-Q2, items for convenience & for burden of disease and treatment were reversed (reversed score = 6 - item score), added together & rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed & rescaled on 0-100 scale to determine satisfaction score. High scores are more favorable.

    PACT−Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from analysis.


  2. Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment [ Time Frame: Visit 1 (Baseline) and last assessment Visit 3 (125-365 days after initiation on Pradaxa or VKA) ]

    Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to baseline assessment. The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). Within the PACT-Q2, 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 were summed and rescaled on a 0-100 scale to determine the satisfaction score. High scores are more favorable.

    PACT−Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.


  3. Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups [ Time Frame: Second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA) ]

    Mean PACT-Q2 scores, for patients in cohort B, at second assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome.

    Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement.

    PACT−Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.


  4. Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups [ Time Frame: Last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA) ]

    Mean PACT-Q2 scores, for patients in cohort B, at last assessment compared between treatment groups.

    Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome.

    Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the last assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement.


  5. Patient Characterization at Baseline - Categorical Parameters [ Time Frame: Baseline (Visit1) ]
    Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).

  6. Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A [ Time Frame: Baseline (Visit1) ]
    Duration of continuous VKA treatment for stroke prevention prior to baseline assessment (Cohort A)


Secondary Outcome Measures :
  1. Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score [ Time Frame: Baseline (Visit1) ]

    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.

    CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.


  2. Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score [ Time Frame: Baseline (Visit1) ]

    HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol.

    HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome.


  3. Patient Characteristics at Baseline - Creatinine Clearance [ Time Frame: Baseline (Visit1) ]
    Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.

  4. Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment [ Time Frame: Second assessment - Visit 2 (7-124 days after initiation on Pradaxa or VKA) and last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA) ]

    Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to second assessment.

    The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items).

    The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3)were compared with the second assessment (Visit 2). Within the PACT-Q2, 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 were summed and rescaled on a 0-100 scale to determine the satisfaction score.


  5. Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B [ Time Frame: Baseline (Visit1) ]

    For Cohort B, scores of PACT-Q1 at baseline were summarised descriptively.

    The PACT-Q1 is composed of a single dimension (7 items) covering the expectations of patients regarding their anticoagulant treatment and is to be administered before treatment initiation.

    The PACT-Q1 scores ranged from 1 (Not at all) to 5 (Extremely/Completely/ Very much).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
SEASK Patients with Non valvuar Atrial Fribrillation
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849509


  Show 50 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Statistical Analysis Plan  [PDF] January 2, 2018
Study Protocol  [PDF] January 25, 2016


Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02849509     History of Changes
Other Study ID Numbers: 1160.261
First Posted: July 29, 2016    Key Record Dates
Results First Posted: July 8, 2019
Last Update Posted: July 8, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vitamins
Vitamin K
Dabigatran
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants