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Patient Convenience Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02597920
First Posted: November 5, 2015
Last Update Posted: February 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 mg or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).

Condition
Atrial Fibrillation

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 Vitamin K Antagonist for Stroke Prophylaxis in Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]
  • Patient characterization at baseline [ Time Frame: 1 day ]
  • 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 ]

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) items at baseline [ Time Frame: 1 day ]

Enrollment: 1852
Study Start Date: November 2015
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Switch patients / A
Patients with non-valvular atrial fibirillation (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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): NCT02597920


  Show 93 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02597920     History of Changes
Other Study ID Numbers: 1160.247
First Submitted: November 4, 2015
First Posted: November 5, 2015
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular 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