Patient Convenience Study- NIS RELATE

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.

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).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Pradaxa (dabigatran); Drug: Vitamin K antagonist

• Study Type: Observational
• Enrollment (Actual): 1313

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta Barat, Indonesia, 11420
    • Harapan Kita National Cardiovascular Center
  • Jakarta Timur, Indonesia, 13750
    • Rumah Sakit Bina Waluya
  • Tangerang, Indonesia, 15811
    • Rumah Sakit Siloam Lippo Karawaci, Tangerang
• Korea, Republic of
  • Ansan, Korea, Republic of, 136-705
    • Korea University Ansan Hospital
  • Bucheon, Korea, Republic of, 422-711
    • Sejong General Hospital
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital
  • Busan, Korea, Republic of, 47392
    • Inje University Busan Paik Hospital
  • Busan, Korea, Republic of, 602-739
    • Pusan National Univ. Hosp
  • Cheonan, Korea, Republic of, 31151
    • Soon Chun Hyang University Hospital Cheonan
  • Cheonan, Korea, Republic of, 330-715
    • Dankook University Hospital
  • Daegu, Korea, Republic of, 700-712
    • Keimyung University Dongsan Medical Center
  • Daegu, Korea, Republic of, 705-703
    • Yeungnam University Medical Center
  • Daegu, Korea, Republic of, 42472
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of, 700-721
    • Kyungpook National Univ. Hosp
  • Daejoen, Korea, Republic of, 301721
    • Chungnam National University Hospital
  • Gwangju, Korea, Republic of, 501-757
    • Chonnam National University Hospital
  • Gwangju, Korea, Republic of, 61453
    • Chosun university hospital
  • Iksan, Korea, Republic of, 570-711
    • Wonkwang University School of Medicine & Hospital
  • Incheon, Korea, Republic of, 405-760
    • Gachon University Gil Medical Center
  • Incheon, Korea, Republic of, 400 711
    • Inha University Hospital
  • Jeju, Korea, Republic of, 690-767
    • Jeju National University Hospital
  • Jeonju, Korea, Republic of, 561-712
    • Chonbuk National University Hospital
  • Jinju, Korea, Republic of, 660-702
    • Gyeongsang National University Hospital
  • Seongnam, Korea, Republic of, 463-707
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 156-755
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of, 135-720
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of, 152-703
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 136-705
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St.Mary's Hospital
  • Seoul, Korea, Republic of, 134-791
    • VHS Medical Center
  • Seoul, Korea, Republic of, 158-710
    • Ewha Womans University Mokdong Hospital
  • Suwon, Korea, Republic of, 443-380
    • Ajou University Hospital
  • Wonju, Korea, Republic of, 220-701
    • Wonju Severance Christian Hosp
• Malaysia
  • Alor Setar, Malaysia, 05460
    • Hospital Sultanah Bahiyah
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
  • Kuala Lumpur, Malaysia, 50400
    • Institut Jantung Negara
  • Kuala Lumpur, Malaysia, 56000
    • Hospital University Kebangsaan Malaysia
  • Kuantan, Malaysia, 25100
    • Hospital Tengku Ampuan Afzan
  • Sg Buloh, Malaysia, 47000
    • UiTM Sg Buloh Campus
• Singapore
  • Singapore, Singapore, 529889
    • Changi General Hospital
  • Singapore, Singapore, 169609
    • National Heart Center
• Thailand
  • Bangkok, Thailand, 10400
    • Pramongkutklao Hospital
  • Bangkok, Thailand, 10220
    • Bhumibol Adulyadej Hospital
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Hospital
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital
  • Chiangmai, Thailand, 50200
    • Chiangmai University
  • Pathum Tani, Thailand, 12120
    • Thammasat University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

SEASK Patients with Non valvuar Atrial Fribrillation

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Switch Patients / A; Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa.	Drug: Pradaxa (dabigatran); Pradaxa (dabigatran etexilate)110mg or 150mg
New Patients / B; Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).	Drug: Vitamin K antagonist; Vitamin K antagonist or Pradaxa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment	Mean Perception of Anticoagulant treatment Questionnaire, part 2 (PACT-Q2) scores, for patients in cohort A, at second assessment compared to baseline assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease & treatment (2 items), & anticoagulant treatment satisfaction (7 items). In this outcome the mean convenience & satisfaction dimension scores of PACT-Q2 at second assessment (Visit 2) were compared with baseline assessment (Visit 1). Within the PACT-Q2, items for convenience & for burden of disease and treatment were reversed (reversed score = 6 - item score), added together & rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed & rescaled on 0-100 scale to determine satisfaction score. High scores are more favorable. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from analysis.	Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment	Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to baseline assessment. The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). Within the PACT-Q2, items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction score. High scores are more favorable. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.	Visit 1 (Baseline) and last assessment Visit 3 (125-365 days after initiation on Pradaxa or VKA)
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups	Mean PACT-Q2 scores, for patients in cohort B, at second assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome. Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.	Second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)
Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups	Mean PACT-Q2 scores, for patients in cohort B, at last assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome. Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the last assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement.	Last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)
Patient Characterization at Baseline - Categorical Parameters	Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).	Baseline (Visit1)
Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A	Duration of continuous VKA treatment for stroke prevention prior to baseline assessment (Cohort A)	Baseline (Visit1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score	CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.	Baseline (Visit1)
Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score	HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome.	Baseline (Visit1)
Patient Characteristics at Baseline - Creatinine Clearance	Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.	Baseline (Visit1)
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment	Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to second assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3)were compared with the second assessment (Visit 2). Within the PACT-Q2, items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction score.	Second assessment - Visit 2 (7-124 days after initiation on Pradaxa or VKA) and last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)
Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B	For Cohort B, scores of PACT-Q1 at baseline were summarised descriptively. The PACT-Q1 is composed of a single dimension (7 items) covering the expectations of patients regarding their anticoagulant treatment and is to be administered before treatment initiation. The PACT-Q1 scores ranged from 1 (Not at all) to 5 (Extremely/Completely/ Very much).	Baseline (Visit1)

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• Lee YS, Oh YS, Choi EK, Chern AKC, Jiampo P, Chutinet A, Hanafy DA, Trivedi P, Zhai D. Patient perception and treatment convenience of dabigatran versus vitamin K antagonist when used for stroke prophylaxis in atrial fibrillation: Real-world Evaluation of Long-term Anticoagulant Treatment Experience (RE-LATE) study. Open Heart. 2021 Dec;8(2). pii: e001745. doi: 10.1136/openhrt-2021-001745.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2016
• Primary Completion (Actual): December 30, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrin Modulating Agents; Protease Inhibitors; Micronutrients; Vitamins; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Antifibrinolytic Agents; Hemostatics; Coagulants; Vitamin K; Dabigatran
• Other Study ID Numbers: 1160.261