Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000786291
Ethics application status
Approved
Date submitted
13/04/2018
Date registered
9/05/2018
Date last updated
9/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patient Satisfaction after Conversion from Warfarin to a Newer Oral Anticoagulant (NOAC)
Scientific title
A Single-centre, Observational, Retrospective Study assessing Patient Satisfaction after Conversion from Warfarin to a Newer Oral Anticoagulant (NOAC)
Secondary ID [1] 294579 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SWAN study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prophylaxis of Venous thromboembolism 307364 0
Condition category
Condition code
Blood 306471 306471 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Retrospective cohort study with prospective assessment of medication satisfaction during NOAC therapy using the Anti-Clot Treatment Scale (ACTS). In addition, a supplementary questionnaire assessed patient’s relative satisfaction with NOAC therapy with their previous warfarin therapy. Retrospective review of patient medical records identified basic demographics and new adverse events.
Intervention code [1] 300869 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305482 0
To assess patient satisfaction with NOAC therapy after conversion from warfarin to a non-vitamin K antagonist oral anticoagulant. Patient-reported satisfaction with NOAC therapy was prospectively assessed using the validated Anti-Clot Treatment Scale (ACTS)
Timepoint [1] 305482 0
Questionnaires were completed at least two months post commencement of NOAC therapy.
Primary outcome [2] 305687 0
To compare patient satisfaction with current NOAC therapy to previous warfarin therapy. A supplementary questionnaire (SWAN survey) was used that directly compared satisfaction with previous warfarin therapy to current NOAC therapy,
Timepoint [2] 305687 0
Atleast two months post commencement of NOAC therapy.
Primary outcome [3] 305688 0
To document the patients preferred anticoagulant therapy based on their previous experience with warfarin and NOAC, At the end of the Swan survey which was specifically designed for this study, participants were asked to mention with reasons, their preferred anticoagulant therapy
Timepoint [3] 305688 0
Atleast two months post commencement of NOAC therapy.
Secondary outcome [1] 346620 0
To document NOAC related adverse events including bleeding-related AEs, thrombotic complications and other AEs from retrospective review of medical records
Timepoint [1] 346620 0
Adverse events were identified from the retrospective review of medical records from the time of commencement of NOAC therapy until the questionnaires were completed. Mean duration of NOAC therapy prior to the survey was 26 months, median 29 months.
Secondary outcome [2] 346622 0
To compare ex-vivo thrombin generation tests in patients who were previously treated on warfarin but are now anticoagulated with rivaroxaban or apixaban. Thrombin generation was assessed by calibrated automated thrombography using 5pM TF (CAT; Thrombinoscope®) wherein lag time, endogenous thrombin potential (ETP), peak thrombin, time to peak thrombin(TTP) and thrombin velocity index were studied.
Timepoint [2] 346622 0
Paired plasma samples were taken within 3 months prior to commencing NOAC and 6 months post switch to NOAC. Laboratory results were identified from the retrospective review of medical records. All patients had received at least 3 months of warfarin therapy and at least 2 weeks of NOAC therapy prior to the respective paired plasma samples.
Secondary outcome [3] 346623 0
To compare in-vivo markers of clotting activation in patients who were previously treated on warfarin but are now anticoagulated with rivaroxaban or apixaban. . Markers of clotting activation were assessed by comparing d-dimer, thrombin-antithrombin III complex and prothrombin fragment 1+2 (PF1+2) plasma concentrations.
Timepoint [3] 346623 0
Paired plasma samples were taken within 3 months prior to commencing NOAC and 6 months post switch to NOAC. Laboratory results were identified from the retrospective review of medical records. All patients had received at least 3 months of warfarin therapy and at least 2 weeks of NOAC therapy prior to the respective paired plasma samples.

Eligibility
Key inclusion criteria
The population for this study consists of patients that have been changed from warfarin to a non-vitamin K antagonist oral anticoagulant (NOAC), rivaroxaban or apixaban, and are currently on one of these two medications. The population will be sourced from the patient pool of Professor Ross Baker at Haematology West, a private haematology practice in Nedlands, Western Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients discontinued or withheld NOAC treatment, re-switched to warfarin or other anticoagulants at the time of enrolment due to various reasons, and participants not willing to participate in the study or declined to answer the survey were excluded from the study.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Patients identified as being currently treated on rivaroxaban or apixaban for the treatment and prevention of recurrence of VTE, and had been switched over to one of these NOACs from warfarin between August 2011 to January 2017 were included in the study. Patient reported satisfaction was prospectively assessed using the Anti-Clot Treatment Scale (ACTS) in addition to a supplementary questionnaire (SWAN survey)
ACTS consists of benefits score (linear scale) and burdens score (inverse scale), Benefits scale comprising 3 questions on benefits and 1 global question and burden scale consisting of 12 questions on burdens and 1 global question. The maximum score is 60, with higher scores indicative of greater satisfaction with the therapy. SWAN survey was composed of seven-item questionnaire, comparing between anticoagulants with regards to side effects, reduced medical contact, dietary restriction, medication interactions, changes in travel, changes in cost and overall satisfaction. Finally the patients were asked to state the preferred anticoagulant with reasons.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/05/2016
Date of last participant enrolment
Anticipated
Actual
30/01/2017
Date of last data collection
Anticipated
Actual
30/03/2017
Sample size
Target
100
Accrual to date
Final
173
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 10632 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 22351 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 299197 0
Other
Name [1] 299197 0
The Perth Blood Institute
Country [1] 299197 0
Australia
Primary sponsor type
Other
Name
The Perth Blood Institute
Address
3/95 Monash Avenue
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 298459 0
None
Name [1] 298459 0
Address [1] 298459 0
Country [1] 298459 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300121 0
Hollywood Private Hospital Research Ethics Committee (HREC)
Ethics committee address [1] 300121 0
Ethics committee country [1] 300121 0
Australia
Date submitted for ethics approval [1] 300121 0
11/03/2016
Approval date [1] 300121 0
02/05/2016
Ethics approval number [1] 300121 0
HPH462

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2592 2592 0 0
/AnzctrAttachments/374894-Swan Study-HREC Approval letter.pdf (Ethics approval)
Attachments [2] 2593 2593 0 0
/AnzctrAttachments/374894-Participant Information Sheet re-formatted 12Aug2016.pdf (Participant information/consent)
Attachments [3] 2594 2594 0 0
/AnzctrAttachments/374894-Anticoagulation QUESTIONAAIRE 11March2016 (1).pdf (Other)

Contacts
Principal investigator
Name 82634 0
Prof Ross Baker
Address 82634 0
The Perth Blood Institute
3/95 Monash Avenue
Nedlands
WA 6009
Country 82634 0
Australia
Phone 82634 0
+61892004904
Fax 82634 0
+61892004905
Email 82634 0
[email protected]
Contact person for public queries
Name 82635 0
Scott McGregor
Address 82635 0
The Perth Blood Institute
3/95 Monash Avenue
Nedlands
WA 6009
Country 82635 0
Australia
Phone 82635 0
+61892004904
Fax 82635 0
+61892004905
Email 82635 0
[email protected]
Contact person for scientific queries
Name 82636 0
Ross Baker
Address 82636 0
The Perth Blood Institute
3/95 Monash Avenue
Nedlands
WA 6009
Country 82636 0
Australia
Phone 82636 0
+61892004904
Fax 82636 0
+61892004905
Email 82636 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePatient satisfaction after conversion from warfarin to direct oral anticoagulants for patients on extended duration of anticoagulation for venous thromboembolism - the SWAN study.2020https://dx.doi.org/10.1371/journal.pone.0234048
N.B. These documents automatically identified may not have been verified by the study sponsor.