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Trial record 97 of 333 for:    DABIGATRAN

Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation

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.
 
ClinicalTrials.gov Identifier: NCT03187197
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Pradaxa®

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Study Type : Observational
Actual Enrollment : 1317 participants
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)
Actual Study Start Date : June 20, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : January 11, 2019


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Mean PACT-Q2 scores compared to baseline [ Time Frame: 30-45 days and 150-210 days ]
    Cohort A (patients switched from VKA to Pradaxa)

  2. Mean PACT-Q2 scores compared between 2 treatment groups. [ Time Frame: 30-45 days and 150-210 days ]
    Cohort B (patients newly initiated Pradaxa or VKA)


Secondary Outcome Measures :
  1. Mean PACT-Q2 score at the last assessment (150-210 days) compared to the second assessment (30-45 days) [ Time Frame: 30-45 days and 150-210 days ]
    Cohort A (patients switched from VKA to Pradaxa)

  2. Description of mean PACT-Q1 score at baseline [ Time Frame: day 1 ]
    Cohort B (patients newly initiated Pradaxa or VKA)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients 20 years of age or older with a diagnosis of non-valvular atrial fibrillation (NVAF).
Criteria

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.

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): NCT03187197


Locations
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Taiwan
Chang-Hua Christian Hospital
Changhua, Taiwan, 500
Show Chwan Memorial Hospital
Changhua, Taiwan
Chia-Yi Christian Hospital
Chia-Yi City, Taiwan, 40705
Hsinchu MacKay Memorial Hospital
Hsinchu, Taiwan
National Taiwan University Hospital-Hsin-Chu Branch
Hsinchu, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 80756
E-Da Hospital
Kaohsiung, Taiwan, 824
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 83301
Far Eastern Memorial Hospital
New Taipei City, Taiwan, 220
Taipei Medical University-Shuang Ho Hospital
New Taipei City, Taiwan, 235
China Medical University Hospital
Taichung, Taiwan, 40447
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
NCKUH
Tainan, Taiwan, 704
Chi Mei Medical Center
Tainan, Taiwan, 710
Tainan Municipal An-Nan Hospital
Tainan, Taiwan
Taipei Medical University Hospital
Taipei City, Taiwan, 110
Taipe Veterans General Hospital
Taipei City, Taiwan, 11217
National Taiwan University Hospital
Taipei, Taiwan, 10048
Mackay Memorial Hospital
Taipei, Taiwan, 10449
Tri-Service General Hospital
Taipei, Taiwan, 114
Shin Kong International HealthCare Center
Taipei, Taiwan
Taipei Municipal Wanfang Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital(TaoYuan)
Taoyuan, Taiwan, 330
National Taiwan University Hospital Yun-Lin Branch
Yunlin County, Taiwan, 632
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03187197     History of Changes
Other Study ID Numbers: 1160-0286
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dabigatran
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action