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Patient Convenience Study (RE-SONANCE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02684981
First Posted: February 18, 2016
Last Update Posted: June 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
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
Atrial Fibrillation Stroke

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Mean Perception of Anticoagulant treatment Questionnaire, part 2 (PACT-Q2) scores, for patients in cohort A, at last assessment compared to baseline assessment [ Time Frame: 180 days ]
  • Mean PACT-Q2 scores, for patients in cohort A, at second assessment compared to baseline assessment [ Time Frame: 40 days ]
  • Mean PACT-Q2 scores, for patients in cohort B, at last assessment compared between treatment groups [ Time Frame: 180 days ]
  • Mean PACT-Q2 scores, for patients in cohort B, at second assessment compared between treatment groups [ Time Frame: 40 days ]
  • Gender [ Time Frame: 1 day ]
  • CHA2DS2-VASc score [ Time Frame: 1 day ]
  • HAS-BLED score (modified HAS-BLED for newly initiated patients) [ Time Frame: 1 day ]
  • Kidney function (creatinine clearance) [ Time Frame: 1 day ]
  • Co-morbidities [ Time Frame: 1 day ]
  • Concomitant therapies [ Time Frame: 1 day ]
  • Dosing of Pradaxa [ Time Frame: 1 day ]
  • Duration of previous VKA treatment (for Cohort A) [ Time Frame: 1 day ]
  • Age [ Time Frame: 1 day ]
  • Stroke- and/or bleeding related risk factors in medical history and at baseline [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to second assessment [ Time Frame: 180 days ]
  • Description of perception of anticoagulant treatment questionnaire, Part 1 (PACT-Q1) at baseline [ Time Frame: 1 day ]

Enrollment: 9513
Actual Study Start Date: November 11, 2015
Study Completion Date: June 1, 2017
Primary Completion Date: June 1, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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
Austria
One or multiple investigational sites, Austria
Bulgaria
One or multiple investigational sites, Bulgaria
Czechia
One or multiple investigational sites, Czechia
Estonia
One or multiple investigational sites, Estonia
Hungary
One or multiple investigational sites, Hungary
Israel
One or multiple investigational sites, Israel
Latvia
One or multiple investigational sites, Latvia
Poland
One or multiple investigational sites, Poland
Romania
One or multiple investigational sites, Romania
Russian Federation
One or multiple investigational sites, Russian Federation
Serbia
One or multiple investigational sites, Serbia
Slovenia
One or multiple investigational sites, Slovenia
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02684981     History of Changes
Other Study ID Numbers: 1160.249
First Submitted: November 11, 2015
First Posted: February 18, 2016
Last Update Posted: June 23, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Vitamin K
Dabigatran
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anticoagulants