Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation


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Verified June 2017 by Boehringer Ingelheim

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT03187197

First received: June 13, 2017

Last updated: June 13, 2017

Last verified: June 2017

To describe the treatment perception from patients with non-valvular atrial fibrillation (NVAF) receiving Pradaxa® or VKA for stroke prevention by using the self-estimation questionnaire of PACT-Q during a 6-month study period.

Atrial Fibrillation Drug: Pradaxa®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patients’ Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation — Impact of Conventional Oral Anticoagulant (OAC) Compared With Novel Oral Anticoagulant (NOAC)

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment: 1000
Anticipated Study Start Date: June 19, 2017
Estimated Study Completion Date: March 29, 2019
Estimated Primary Completion Date: March 29, 2019 (Final data collection date for primary outcome measure)
Cohort A

consented patients with NVAF in Taiwan with a previous VKA therapy, followed by switching to Pradaxa®

Drug: Pradaxa®

Dabigatran etexilate

Other Name: Dabigatran etexilate

Cohort B

patients being newly diagnosed with NVAF and initiated on Pradaxa®

Drug: Pradaxa®

Dabigatran etexilate

Other Name: Dabigatran etexilate

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Patients 20 years of age or older with a diagnosis of non-valvular atrial fibrillation (NVAF).

Inclusion criteria:

Cohort A (patients switched from VKA to Pradaxa)

  • Written informed consent prior to participation.
  • Female or male patients ≥ 20 years of age with a diagnosis of non-valvular atrial fibrillation (NVAF).
  • At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
  • Patients switched to Pradaxa prior to baseline assessment according to the physician’s discretion and the Summary of Product Characteristics (SmPCs)/reimbursement criteria.

OR Cohort B (patients newly initiated Pradaxa or VKA)

  • Written informed consent prior to participation.
  • Female or male patients ≥ 20 years of age, newly diagnosed with NVAF, and no previous treatment for stroke prevention (no use of any OAC within 1 year prior to enrolment).
  • Patients initiated stroke prevention treatment with Pradaxa or VKA according to the physician’s discretion and the SmPCs/reimbursement criteria.

Exclusion criteria:

  • Contraindication to the use of Pradaxa® or VKA as described in the SmPCs.
  • Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in NVAF.
  • Current participation in any clinical trial of a drug or device.
  • Current participation in an AF-related registry, e.g. the Gloria AF program.

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, see Learn About Clinical Studies.

No Contacts or Locations Provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03187197     History of Changes
Other Study ID Numbers: 1160-0286
Study First Received: June 13, 2017
Last Updated: June 13, 2017

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants

ClinicalTrials.gov processed this record on June 14, 2017