Trial Outcomes & Findings for Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation (NCT NCT02433366)

Results Overview

The Outcome measure is summarized using the following categories; A: Physicians who spontaneously remembered the receipt of the Patient alert card, B: Physicians who spontaneously remembered the receipt of the Prescriber Guide, C: Physicians who were satisfied with the information provided in the Prescriber guide, D: Physicians who were aware of the importance of determining and controlling of the Patients renal function for correct pradaxa dosing. This Outcome measure is applicable only for the Physicians group.

Recruitment status

COMPLETED

Target enrollment

1213 participants

Primary outcome timeframe

Day 1

Results posted on

2016-09-19

Participant Flow

This is a cross-sectional survey. Pradaxa® prescribing healthcare professionals and Pradaxa® treated patients were randomly selected and interviewed (face-to-face). 411 healthcare professionals and 802 patients with atrial fibrillation were enrolled and entered the study

Participant milestones

Participant milestones
Measure	Physicians Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).	Patients AF patients on treatment with Pradaxa®.
Overall Study STARTED	411	802
Overall Study COMPLETED	411	802
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Physicians n=411 Participants Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).	Patients n=802 Participants AF patients on treatment with Pradaxa®.	Total n=1213 Participants Total of all reporting groups
Age, Customized <75 years	NA Participants n=5 Participants	480 Participants n=7 Participants	NA Participants n=5 Participants
Age, Customized ≥ 75 years	NA Participants n=5 Participants	322 Participants n=7 Participants	NA Participants n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants	370 Participants n=7 Participants	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants	432 Participants n=7 Participants	NA Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Physicians who were current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF)

The Outcome measure is summarized using the following categories; A: Physicians who spontaneously remembered the receipt of the Patient alert card, B: Physicians who spontaneously remembered the receipt of the Prescriber Guide, C: Physicians who were satisfied with the information provided in the Prescriber guide, D: Physicians who were aware of the importance of determining and controlling of the Patients renal function for correct pradaxa dosing. This Outcome measure is applicable only for the Physicians group.

Outcome measures

Outcome measures
Measure	Physicians n=411 Participants Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).	Patients AF patients on treatment with Pradaxa®.
Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire) B	71 Percentage of Participants	—
Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire) A	65 Percentage of Participants	—
Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire) C	95 Percentage of Participants	—
Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire) D	100 Percentage of Participants	—

PRIMARY outcome

Timeframe: Day 1

Population: AF patients on treatment with Pradaxa®.

The Outcome measure is summarized using the following categories; A: Patients who received the Patient Alert Card, read it and understood its content, B: Patients who completed the Patient Alert Card with the patient specific information, C: Patients who were well informed about their treatment and the actions to be taken in case of serious complications, D: Patents who knew about the anticoagulant effect of Pradaxa®, E: Patients who were well aware of the potential side effect-bruising, F: Patients who were well aware of the potential side effect-bleeding. This Outcome measure is applicable only for the Patients group.

Outcome measures

Outcome measures
Measure	Physicians Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).	Patients n=802 Participants AF patients on treatment with Pradaxa®.
Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire) A	—	55 Percentage of Participants
Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire) B	—	83 Percentage of Participants
Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire) C	—	100 Percentage of Participants
Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire) D	—	89 Percentage of Participants
Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire) E	—	54 Percentage of Participants
Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire) F	—	52 Percentage of Participants

Adverse Events

Physicians

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights
Publication restrictions are in place

Restriction type: OTHER