Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF)

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

1600 AF patients receiving Pradaxa or VKA for stroke prevention will be followed up for 12 months in quarterly visits. Prescriptions, adverse events and (if applicable) reasons for definitive treatment discontinuation will be collected. At 6 months, patient adherence will be assessed, using the Morisky Score. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: Dabigatran etexilate and Vitamin K antagonists
Type of treatment: Pill or oral medicine
How many people: 1,506 participants
Where: 1 siteGermany
Study dates: 18 Sep 2014to 31 Dec 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: AF patients

Who may be able to join

Newly prescribed treatment with Pradaxa® (dabigatran etexilate)/VKA in the indication "Stroke prevention in non-valvular atrial fibrillation" (AF) respecting the indication and contraindications as described in the respective Summary of Product Characteristics for Pradaxa® 110 mg or 150 mg hard capsules or the appropriate VKA (patients are eligible for both Pradaxa® and VKA therapy).
Treatment with dabigatran etexilate or VKA is given in accordance with the respective Summaries of Product Characteristics. The routine diagnostic procedures and treatment that would be undertaken irrespective of the study are unaffected.
Only patients who are eligible both for therapy with Pradaxa® and for therapy with VKA in accordance with the respective Summaries of Product Characteristics will be documented (patients eligible for VKA and Pradaxa®)
Patients must have signed the patient consent form prior to inclusion in the Non-Interventional Study (NIS).

Who cannot join

Patients with the general and special contraindications mentioned in the packaging leaflet or Summary of Product Characteristics must not be included.
Patients participating at the same time or within the last 30 days in another Non-Interventional Study (NIS) or an interventional clinical trial must not be included.
Patients treated with anticoagulants for a condition other than non-valvular atrial fibrillation must not be included.
Pradaxa® and VKA should not be used during pregnancy and lactation. Pregnant or breastfeeding women must therefore not be included in the NIS.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Multiple Locations

Other trials in Germany

About this study

Official title: Drug Persistence/Adherence in Patients Being Treated With Dabigatran Etexilate or VKA for Stroke Prevention in Non-valvular Atrial Fibrillation (SPAF)

Conditions: Atrial Fibrillation
Being tested: Dabigatran etexilate, Vitamin K antagonists
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dabigatran etexilateDrug
150 mg or 110 mg capsules twice daily
Vitamin K antagonistsDrug
Also called Phenprocoumon
International Normalized Ratio (INR) 2-3

Study groups in NCT02240667
Study group	Role	What they receive
Subjects with atrial fibrillation		Not described Receives: Drug: Dabigatran etexilate; Drug: Vitamin K antagonists

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month
Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy.
Measured: 12 month (Visit 5)

Secondary outcomes (2)

Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit.
Percentage of patients with low, medium or high adherence at the 6-month visit, stratified for dabigatran etexilate and VKA; categorisation is done on the basis of the Morisky questionnaire (high, medium and low adherence with a Morisky score of 0, 1 to 2, and > 2, respectively).
Measured: 6 month (visit 3)
Number of Patients With the Reason for Definitive Treatment Discontinuation
Number of patients with the reason for definitive treatment discontinuation
Measured: Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Sep 201431 Dec 2017

First posted16 Sep 2014 (estimated)
Study start18 Sep 2014
Primary completion31 Dec 2017
Study completion31 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,506 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02240667
Sponsor's protocol ID: 1160.218
Status last verified: Apr 2019
First submitted: 15 Sep 2014
Last updated: 19 Apr 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Drug Persistence/Adherence in Patients Being Treated With Dabigatran Etexilate or VKA for Stroke Prevention in Non-valvular Atrial Fibrillation (SPAF)
ClinicalTrials.gov ID: NCT02240667
Acronym / sponsor ID: 1160.218
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 1,506 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 18 Sep 2014 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 31 Dec 2017 (actual)
First posted: 16 Sep 2014 (estimated)
Results: Posted 19 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Subjects with atrial fibrillation	–	Drug: Dabigatran etexilate, Drug: Vitamin K antagonists

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: AF patients

Key inclusion criteria (4 listed)

Newly prescribed treatment with Pradaxa® (dabigatran etexilate)/VKA in the indication "Stroke prevention in non-valvular atrial fibrillation" (AF) respecting the indication and contraindications as described in the respective Summary of Product Characteristics for Pradaxa® 110 mg or 150 mg hard capsules or the appropriate VKA (patients are eligible for both Pradaxa® and VKA therapy).
Treatment with dabigatran etexilate or VKA is given in accordance with the respective Summaries of Product Characteristics. The routine diagnostic procedures and treatment that would be undertaken irrespective of the study are unaffected.
Only patients who are eligible both for therapy with Pradaxa® and for therapy with VKA in accordance with the respective Summaries of Product Characteristics will be documented (patients eligible for VKA and Pradaxa®)
Patients must have signed the patient consent form prior to inclusion in the Non-Interventional Study (NIS).

Key exclusion criteria (4 listed)

Patients with the general and special contraindications mentioned in the packaging leaflet or Summary of Product Characteristics must not be included.
Patients participating at the same time or within the last 30 days in another Non-Interventional Study (NIS) or an interventional clinical trial must not be included.
Patients treated with anticoagulants for a condition other than non-valvular atrial fibrillation must not be included.
Pradaxa® and VKA should not be used during pregnancy and lactation. Pregnant or breastfeeding women must therefore not be included in the NIS.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dabigatran etexilate150 mg or 110 mg capsules twice daily	Drug	Subjects with atrial fibrillation
Vitamin K antagonistsAlso: PhenprocoumonInternational Normalized Ratio (INR) 2-3	Drug	Subjects with atrial fibrillation

Primary outcome

Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month
Time frame: 12 month (Visit 5)
Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy.

2 secondary outcomes

Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit.
Time frame: 6 month (visit 3)
Number of Patients With the Reason for Definitive Treatment Discontinuation
Time frame: Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment)

Results and safety

Results posted to the registry on 19 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dabigatran (Dabigatran vs VKA)	771	771
Vitamin K Antagonists (VKA)	650	650

Primary outcome: Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month

Time frame: 12 month (Visit 5). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Dabigatran (Dabigatran vs VKA) n = 476	VKA (Dabigatran vs VKA) n = 476
Value	89.5 (86.3 to 91.9)	89.5 (86.3 to 92.0)

Dabigatran (Dabigatran vs VKA) vs VKA (Dabigatran vs VKA): p = 0.8496, stratified log-rank test

Population analysed: Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of treatment until six days after permanent treatment discontinuation or end of study, up to 12 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran (Dabigatran vs VKA)	45 of 771 (5.8%)	0 of 771 (0%)	10 of 771
Vitamin K Antagonists (VKA)	39 of 650 (6%)	0 of 650 (0%)	5 of 650

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month (time frame: 12 month (Visit 5)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02240667.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.