Patient Convenience Study- NIS RELATE

Atrial Fibrillation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849509
• Other study ID #: 1160.261
• Status: Completed
• Start date: June 20, 2016
• Est. completion date: December 30, 2017

Study information

• Verified date: April 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1313
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Pradaxa (dabigatran)
Pradaxa (dabigatran etexilate)110mg or 150mg
• Vitamin K antagonist
Vitamin K antagonist or Pradaxa

Locations

Country	Name	City	State
Indonesia	Harapan Kita National Cardiovascular Center	Jakarta Barat
Indonesia	Rumah Sakit Bina Waluya	Jakarta Timur
Indonesia	Rumah Sakit Siloam Lippo Karawaci, Tangerang	Tangerang
Korea, Republic of	Korea University Ansan Hospital	Ansan
Korea, Republic of	Sejong General Hospital	Bucheon
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Pusan National Univ. Hosp	Busan
Korea, Republic of	Dankook University Hospital	Cheonan
Korea, Republic of	Soon Chun Hyang University Hospital Cheonan	Cheonan
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Kyungpook National Univ. Hosp	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejoen
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Chosun University Hospital	Gwangju
Korea, Republic of	Wonkwang University School of Medicine & Hospital	Iksan
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Jeju National University Hospital	Jeju
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Gyeongsang National University Hospital	Jinju
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St.Mary's Hospital	Seoul
Korea, Republic of	VHS Medical Center	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	Wonju Severance Christian Hosp	Wonju
Malaysia	Hospital Sultanah Bahiyah	Alor Setar
Malaysia	Hospital University Kebangsaan Malaysia	Kuala Lumpur
Malaysia	Institut Jantung Negara	Kuala Lumpur
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Hospital Tengku Ampuan Afzan	Kuantan
Malaysia	UiTM Sg Buloh Campus	Sg Buloh
Singapore	Changi General Hospital	Singapore
Singapore	National Heart Center	Singapore
Thailand	Bhumibol Adulyadej Hospital	Bangkok
Thailand	King Chulalongkorn Hospital	Bangkok
Thailand	Pramongkutklao Hospital	Bangkok
Thailand	Ramathibodi Hospital	Bangkok
Thailand	Chiangmai University	Chiangmai
Thailand	Thammasat University Hospital	Pathum Tani

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Indonesia,  Korea, Republic of,  Malaysia,  Singapore,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

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