Treatment Convenience in Patients Treated With Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF)

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02839746
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Describe patient and physician assessed factors for patient well-being when treated with Pradaxa for stroke and embolism prevention in atrial fibrillation either compared to previous antithrombotic treatment (switcher)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-02
• Study Start: 2016-06-13
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-21
• Primary Completion: 2018-10-10
• Study Completion: 2018-10-10
• Status Verified: 2019-10
• Results First Submitted: 2019-10-10
• Results First Submitted QC: 2019-10-10
• Last Update Submitted: 2019-10-10
• Results First Posted: 2019-11-01
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 671

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Second Assessment Compared to Baseline Assessment	When planned to be switched from VKA to Pradaxa® (At baseline, Visit 1), 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2)	The PACT-Q is self-administered quest. which was developed as means to investigate patients' satisfaction with anticoagulant treatment \& treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). PACT-Q2 quest. is made up of two domains: (1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question \& converting to a scale from 0 to 100. (2) Satisfaction with the anticoagulant treatment (7 items): This domain is calculated by adding scores for each of the 7 items in question \& converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of the dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction. The two domain scores are presented for Baseline, Visit 2 (second assessment) as mean \& standard deviation (SD).
Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Last Assessment Compared to Baseline Assessment	When planned to be switched from VKA to Pradaxa® (At baseline, Visit 1), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)	The PACT-Q is self-administered quest. which was developed as means to investigate patients satisfaction with anticoagulant treatment \& treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 quest. is made up of two domains: 1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question, \&converting to a scale from 0 to 100. 2) Satisfaction with the anticoagulant treatment (7 items):This domain is calculated by adding scores for each of the 7 items in question, \& converting to a scale from 0 to 100.; The missing items have been replaced by the mean of non-missing items of the dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction.; The two domain scores are presented for Baseline, Visit 3 (last assessment) as mean and standard deviation (SD).
Mean of Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) Score at Last Assessment Compared to Second Assessment	7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)	The PACT-Q is self-administered quest. which was developed as means to investigate patients satisfaction with anticoagulant treatment \& treatment convenience in patients with DVT, PE or AF. The PACT-Q2 quest. is made up of two domains: 1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question, \&converting to a scale from 0 to 100. 2) Satisfaction with the anticoagulant treatment (7 items):This domain is calculated by adding scores for each of the 7 items in question, \& converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction.; The two domain scores are presented for Visit 2( second assessment), Visit 3 (last assessment) as mean and standard deviation (SD).

Secondary Outcome Measures

Name	Time	Method
Patient Characteristics at Baseline - Categorical Parameters	Baseline	Categorical parameters of the patient characteristics at baseline included age, Risk factors associated with stroke and/or haemorrhage in the medical history (MH), co-morbidities (CoMo), concomitant medication (CM) and dosing of Pradaxa® (DoP).; Haemorrhagic risk (HAS-BLED) is categorized as Low risk (score 0), Moderate risk (score 1-2) and High Risk (score ≥3). Thromboembolic risk (CHA2DS2-VASc) is categorized as Low risk (score 0 in male and 1 in female), Moderate risk (score 1 in male and 2 in female) and High Risk (score ≥2 in male and ≥3 in female).; Stages of kidney disease are categorized based on Cockcroft-Gault review as below: No kidney failure (\> 80 ml/min), Mild kidney failure (50-80 ml/min), Moderate kidney failure (30-49 ml/min), Severe kidney failure (15-29 ml/min) and End-stage kidney failure/dialysis (\< 15 ml/min).
Patient Characteristics at Baseline - Creatinine Clearance	Baseline	Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score	Baseline	CHA2DS2-VASc stroke risk score is calculated based on following conditions: Congestive heart failure/left ventricular dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus,Stroke/Transient Ischaemic Attack (TIA)/thromboembolism,Vascular disease (history of myocardial infarction, peripheral artery disease or aortic plaque) ,Age 65-74, Sex category. HAS-BLED bleeding risk score is calculated based on following conditions: Uncontrolled hypertension with Systolic Blood pressure (SBP) ≥ 160 mmHg,Kidney failure,liver failure,History of stroke,History of bleeding, anaemia or predisposition to bleeding,Unstable/high or poor international normalized ratio (INR) (\<60% of time within therapeutic range),Elderly (\>65 years),Medications that affect haemostasis,Consumptions of ≥8 alcoholic drinks per week.CHA2DS2-VASc stroke risk score \& HAS-BLED bleeding risk score range from 0 to 9 with 0 being outcome with low stroke risk for CHA2DS2-VASc and being with low bleeding risk for HAS-BLED.
Reason for Changing the Dose of Pradaxa®: 150 mg/ Twice Daily (Bid) to 110 mg/Bid	7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)	Reasons for for changing the dose of Pradaxa®: 150 mg/bid to 110 mg/bid are categorized as below: 1\] High risk of bleeding 2\] Moderate renal failure 3\] \>80 years 4\] Other reason
Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration	Baseline	Vitamin K Antagonist (VKA) treatment duration is one of the baseline patient characteristics.
Patient Characteristics at Baseline - Reasons for Switching From VKAs to Pradaxa®	Baseline	Categories of reasons for switching from VKAs to Pradaxa® are as below: 1. Hypersensitivity (Hypersensitivity to the drug); 2. Intracranial haemorrhage (Patients with a history of intracranial haemorrhage (ICH) (except during the acute phase) in whom the benefits of anticoagulation were deemed to outweigh the risk of haemorrhage); 3. Ischaemic stroke (Patients with ischaemic stroke who present clinical and neuroimaging criteria indicating a high risk of ICH); 4. Arterial thromboembolic episodes (Patients undergoing treatment with VKAs, suffering from severe arterial thromboembolic episodes despite good INR control); 5. INR not in range (Patients who have started treatment with VKAs in whom it is not possible to keep the INR in range (2-3) despite good therapeutic compliance); 6. INR management (Lack of access to conventional INR management); 7. Pts decision (Patient's decision); 8. Others.; A single patient may have specified more than one reason
Reason for Changing the Dose of Pradaxa®: 110 mg/Bid to 150 mg/Bid	7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)	Reasons for for changing the dose of Pradaxa®: 110 mg/bid to 150 mg/bid are categorized as below: 1\] High risk of bleeding 2\] Moderate renal failure 3\] \>80 years 4\] Other reason
Reasons for no Longer Receiving Pradaxa® Treatment	7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)	Reasons for no longer receiving Pradaxa® treatment categorized as below: 1. Treatment change (Change of treatment (by patient or by investigator); 2. Adverse event (Diarrhea, gastrointestinal discomfort, rectorrhagia, dyspepsia); 3. Exitus; 4. Others