Patient Convenience Study- NIS RELATE

NCT02849509 | Completed Results

• 1 other identifier: 1160.261
• Study Type: observational
• Target: 1,313
• Locations: 5 countries
• Sites: 50

Brief Summary

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).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score

  Baseline (Visit1)

• Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score

  Baseline (Visit1)

• Patient Characteristics at Baseline - Creatinine Clearance

  Baseline (Visit1)

• Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment

  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

  Baseline (Visit1)

Study Arms (2)

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)

New Patients / B

Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).

Drug: Vitamin K antagonist

Interventions

Pradaxa (dabigatran) DRUG

Pradaxa (dabigatran etexilate)110mg or 150mg

Switch Patients / A

Vitamin K antagonist DRUG

Vitamin K antagonist or Pradaxa

New Patients / B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SEASK Patients with Non valvuar Atrial Fribrillation

You may qualify if:

• Cohort A:
• A. Written informed consent prior to participation
• A. Female and male patients \>= 18 years of age with a diagnosis of non-valvular atrial fibrillation.
• A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
• A. Patients switched to Pradaxa® according Summary of Product Characteristics and physician's discretion.
• Cohort B:
• B. Written informed consent prior to participation.
• 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).
• B. Stroke prevention treatment initiated with Pradaxa® or VKA according to Summary of Product Characteristics and physician's discretion.

You may not qualify if:

• Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC).
• Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in atrial fibrillation.
• Current participation in any clinical trial of a drug or device.
• Current participation in an European registry on the use of oral anticoagulation in AF.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (50)

Harapan Kita National Cardiovascular Center

Jakarta Barat, 11420, Indonesia

Location

Rumah Sakit Bina Waluya

Jakarta Timur, 13750, Indonesia

Location

Rumah Sakit Siloam Lippo Karawaci, Tangerang

Tangerang, 15811, Indonesia

Location

Hospital Sultanah Bahiyah

Alor Star, 05460, Malaysia

Location

Institut Jantung Negara

Kuala Lumpur, 50400, Malaysia

Location

Hospital University Kebangsaan Malaysia

Kuala Lumpur, 56000, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Hospital Tengku Ampuan Afzan

Kuantan, 25100, Malaysia

Location

UiTM Sg Buloh Campus

Sg Buloh, 47000, Malaysia

Location

National Heart Center

Singapore, 169609, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

Korea University Ansan Hospital

Ansan, 136-705, South Korea

Location

Sejong General Hospital

Bucheon-si, 422-711, South Korea

Location

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Pusan National Univ. Hosp

Busan, 602-739, South Korea

Location

Soon Chun Hyang University Hospital Cheonan

Cheonan, 31151, South Korea

Location

Dankook University Hospital

Cheonan, 330-715, South Korea

Location

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Location

Kyungpook National Univ. Hosp

Daegu, 700-721, South Korea

Location

Yeungnam University Medical Center

Daegu, 705-703, South Korea

Location

Chungnam National University Hospital

Daejoen, 301721, South Korea

Location

Chonnam National University Hospital

Gwangju, 501-757, South Korea

Location

Chosun University Hospital

Gwangju, 61453, South Korea

Location

Wonkwang University School of Medicine & Hospital

Iksan, 570-711, South Korea

Location

Inha University Hospital

Incheon, 400 711, South Korea

Location

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

Location

Jeju National University Hospital

Jeju City, 690-767, South Korea

Location

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Location

Gyeongsang National University Hospital

Jinju, 660-702, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

Location

The Catholic University of Korea, Seoul St.Mary's Hospital

Seoul, 06591, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

VHS Medical Center

Seoul, 134-791, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Gangnam Severance Hospital

Seoul, 135-720, South Korea

Location

Korea University Anam Hospital

Seoul, 136-705, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Chung-Ang University Hospital

Seoul, 156-755, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, 158-710, South Korea

Location

Ajou University Hospital

Suwon, 443-380, South Korea

Location

Wonju Severance Christian Hosp

Wŏnju, 220-701, South Korea

Location

Bhumibol Adulyadej Hospital

Bangkok, 10220, Thailand

Location

King Chulalongkorn Hospital

Bangkok, 10330, Thailand

Location

Pramongkutklao Hospital

Bangkok, 10400, Thailand

Location

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Chiangmai University

Chiang Mai, 50200, Thailand

Location

Thammasat University Hospital

Pathum Tani, 12120, Thailand

Location

Related Publications (1)

• 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):e001745. doi: 10.1136/openhrt-2021-001745.

  PMID: 34857666 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran; acarboxyprothrombin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The choice of anticoagulant treatment was at the discretion of the treating physician and independent from study participation. The planned between-country comparisons of study results could not be performed or were not meaningful when performed.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: July 29, 2016
• Study Start: June 20, 2016
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: July 8, 2019
• Results First Posted: July 8, 2019

Record last verified: 2019-04

Locations

TH (6); MY (6); SG (2); ID (3); KR (33)