- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02839746
Treatment Convenience in Patients Treated With Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF)
Non-interventional Study Describing Treatment Convenience in Patients Treated With Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF)
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Multiple Locations, Spania
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Dabigatran
Patients switched from vitamin K antagonist (VKA) to dabigatran
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Second Assessment Compared to Baseline Assessment
Tidsramme: 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)
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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).
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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)
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Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Last Assessment Compared to Baseline Assessment
Tidsramme: 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)
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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)
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Mean of Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) Score at Last Assessment Compared to Second Assessment
Tidsramme: 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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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)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score
Tidsramme: Baseline
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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.
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Baseline
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Patient Characteristics at Baseline - Categorical Parameters
Tidsramme: Baseline
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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
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Patient Characteristics at Baseline - Creatinine Clearance
Tidsramme: Baseline
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Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.
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Baseline
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Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration
Tidsramme: Baseline
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Vitamin K Antagonist (VKA) treatment duration is one of the baseline patient characteristics.
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Baseline
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Patient Characteristics at Baseline - Reasons for Switching From VKAs to Pradaxa®
Tidsramme: Baseline
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Categories of reasons for switching from VKAs to Pradaxa® are as below:
A single patient may have specified more than one reason |
Baseline
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Reason for Changing the Dose of Pradaxa®: 150 mg/ Twice Daily (Bid) to 110 mg/Bid
Tidsramme: 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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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)
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Reason for Changing the Dose of Pradaxa®: 110 mg/Bid to 150 mg/Bid
Tidsramme: 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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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)
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Reasons for no Longer Receiving Pradaxa® Treatment
Tidsramme: 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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Reasons for no longer receiving Pradaxa® treatment categorized as below:
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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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Samarbeidspartnere og etterforskere
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Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1160.253
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