Patient Convenience Study (RE-SONANCE)

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684981
• Other study ID #: 1160.249
• Status: Completed
• Start date: November 11, 2015
• Est. completion date: June 1, 2017

Study information

• Verified date: May 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9472
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Bulgaria,  Czechia,  Estonia,  Hungary,  Israel,  Latvia,  Poland,  Romania,  Russian Federation,  Serbia,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Convenience PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment	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.	From baseline up to 210 days
Primary	Satisfaction PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment	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.	From baseline up to 210 days
Primary	Convenience PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups	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.	Day 30 up to Day 210
Primary	Satisfaction PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups	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.	Day 30 up to Day 210
Primary	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	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.	Baseline
Primary	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	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.	Baseline
Primary	Characterization of Patients With Respect to Kidney Function (Creatinine Clearance)	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).	Baseline and up to 210 days
Primary	Characterization of Patients With Respect to Comorbidities	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.	Baseline
Primary	Characterization of Patients With Respect to Concomitant Therapies	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.	Baseline
Primary	Characterization of Patients With Respect to Dosing of Pradaxa	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).	Baseline and up to 210 days
Primary	Duration in Months of Previous VKA Treatment	The data presented in this outcome measure are Mean (SD) of duration in months of previous VKA treatment in total patients in cohort A.	Baseline
Primary	Stroke- and/or Bleeding Related Risk Factors in Medical History and at Baseline (Not Applicable)	This endpoint is not assessable as the necessary data was not collected in the database	Baseline
Secondary	PACT-Q2 Scores at Last Assessment Compared to Second Assessment	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).	From 30 days up to 210 days
Secondary	Description of PACT-Q1 Items at 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.	Baseline

External Links

•   Link