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

Atrial Fibrillation Clinical Trial

Official title:

Non-interventional Study Describing Treatment Convenience in Patients Treated With Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02839746
• Other study ID #: 1160.253
• Status: Completed
• Start date: June 13, 2016
• Est. completion date: October 10, 2018

Study information

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

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 671
• Est. completion date: October 10, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion criteria:

• Written informed consent prior to participation

• Female and male patients 18 years of age or older with a diagnosis of non-valvular atrial fibrillation.

• At least 6 months of continuous vitamin K antagonist (VKA) treatment for stroke prevention prior to baseline assessment.

• Patients switched to Pradaxa® according to Summary of Product Characteristics, therapeutic positioning report from Spanish competent authorities and visa from each autonomous community.

Exclusion criteria:

• Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC)

• Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in non-valvular atrial fibrillation.

• Current participation in any clinical trial of a drug or device

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Second Assessment Compared to Baseline Assessment	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).	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)
Primary	Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Last Assessment Compared to Baseline Assessment	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).	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)
Primary	Mean of Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) Score at Last Assessment Compared to Second Assessment	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).	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)
Secondary	Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score	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.	Baseline
Secondary	Patient Characteristics at Baseline - Categorical Parameters	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).	Baseline
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
Secondary	Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration	Vitamin K Antagonist (VKA) treatment duration is one of the baseline patient characteristics.	Baseline
Secondary	Patient Characteristics at Baseline - Reasons for Switching From VKAs to Pradaxa®	Categories of reasons for switching from VKAs to Pradaxa® are as below: Hypersensitivity (Hypersensitivity to the drug); 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); Ischaemic stroke (Patients with ischaemic stroke who present clinical and neuroimaging criteria indicating a high risk of ICH); Arterial thromboembolic episodes (Patients undergoing treatment with VKAs, suffering from severe arterial thromboembolic episodes despite good INR control); 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); INR management (Lack of access to conventional INR management); Pts decision (Patient's decision); Others.; A single patient may have specified more than one reason	Baseline
Secondary	Reason for Changing the Dose of Pradaxa®: 150 mg/ Twice Daily (Bid) to 110 mg/Bid	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	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)
Secondary	Reason for Changing the Dose of Pradaxa®: 110 mg/Bid to 150 mg/Bid	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	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)
Secondary	Reasons for no Longer Receiving Pradaxa® Treatment	Reasons for no longer receiving Pradaxa® treatment categorized as below: Treatment change (Change of treatment (by patient or by investigator); Adverse event (Diarrhea, gastrointestinal discomfort, rectorrhagia, dyspepsia); Exitus; Others	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)

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