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Patient Convenience Study (RE-SONANCE)

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ClinicalTrials.gov Identifier: NCT02684981
Recruitment Status : Completed
First Posted : February 18, 2016
Results First Posted : July 24, 2019
Last Update Posted : July 24, 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 milligrams or 150 milligrams twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).

Condition or disease
Atrial Fibrillation Stroke

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Study Type : Observational
Actual Enrollment : 9472 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 Vitamine K Antagonist for Stroke Prevention in Non-Valvular Atrial Fibrillation
Actual Study Start Date : November 11, 2015
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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.
Cohort B - newly assigned to treatment
Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).



Primary Outcome Measures :
  1. Convenience PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment [ Time Frame: From baseline up to 210 days ]
    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.

  2. Satisfaction PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment [ Time Frame: From baseline up to 210 days ]
    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.

  3. Convenience PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups [ Time Frame: Day 30 up to Day 210 ]
    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.

  4. Satisfaction PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups [ Time Frame: Day 30 up to Day 210 ]
    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.

  5. 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 [ Time Frame: Baseline ]
    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.

  6. 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 [ Time Frame: Baseline ]
    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.

  7. Characterization of Patients With Respect to Kidney Function (Creatinine Clearance) [ Time Frame: Baseline and up to 210 days ]
    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).

  8. Characterization of Patients With Respect to Comorbidities [ Time Frame: Baseline ]
    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.

  9. Characterization of Patients With Respect to Concomitant Therapies [ Time Frame: Baseline ]
    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.

  10. Characterization of Patients With Respect to Dosing of Pradaxa [ Time Frame: Baseline and up to 210 days ]
    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).

  11. Duration in Months of Previous VKA Treatment [ Time Frame: Baseline ]
    The data presented in this outcome measure are Mean (SD) of duration in months of previous VKA treatment in total patients in cohort A.

  12. Stroke- and/or Bleeding Related Risk Factors in Medical History and at Baseline (Not Applicable) [ Time Frame: Baseline ]
    This endpoint is not assessable as the necessary data was not collected in the database


Secondary Outcome Measures :
  1. PACT-Q2 Scores at Last Assessment Compared to Second Assessment [ Time Frame: From 30 days up to 210 days ]
    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).

  2. Description of PACT-Q1 Items at Baseline [ Time Frame: Baseline ]
    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.



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
European patients with non valvular atrial fibrillation
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): NCT02684981


Locations
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Austria
Multiple Locations, Austria
Bulgaria
Multiple Locations, Bulgaria
Czechia
Multiple Locations, Czechia
Estonia
Multiple Locations, Estonia
Hungary
Multiple Locations, Hungary
Israel
Multiple Locations, Israel
Latvia
Multiple Locations, Latvia
Poland
Multiple Locations, Poland
Romania
Multiple Locations, Romania
Russian Federation
Multiple Locations, Russian Federation
Serbia
Multiple Locations, Serbia
Slovenia
Multiple Locations, Slovenia
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] November 21, 2017
Study Protocol  [PDF] July 23, 2015

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02684981    
Other Study ID Numbers: 1160.249
First Posted: February 18, 2016    Key Record Dates
Results First Posted: July 24, 2019
Last Update Posted: July 24, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Atrial Fibrillation
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes