- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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)
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Multiple Locations, Spanien
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
---|
Dabigatran
Patients switched from vitamin K antagonist (VKA) to dabigatran
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Second Assessment Compared to Baseline Assessment
Tidsram: 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).
|
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)
|
Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Last Assessment Compared to Baseline Assessment
Tidsram: 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). |
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)
|
Mean of Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) Score at Last Assessment Compared to Second Assessment
Tidsram: 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). |
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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score
Tidsram: 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.
|
Baseline
|
Patient Characteristics at Baseline - Categorical Parameters
Tidsram: 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). |
Baseline
|
Patient Characteristics at Baseline - Creatinine Clearance
Tidsram: Baseline
|
Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.
|
Baseline
|
Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration
Tidsram: Baseline
|
Vitamin K Antagonist (VKA) treatment duration is one of the baseline patient characteristics.
|
Baseline
|
Patient Characteristics at Baseline - Reasons for Switching From VKAs to Pradaxa®
Tidsram: Baseline
|
Categories of reasons for switching from VKAs to Pradaxa® are as below:
A single patient may have specified more than one reason |
Baseline
|
Reason for Changing the Dose of Pradaxa®: 150 mg/ Twice Daily (Bid) to 110 mg/Bid
Tidsram: 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 |
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)
|
Reason for Changing the Dose of Pradaxa®: 110 mg/Bid to 150 mg/Bid
Tidsram: 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 |
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
Tidsram: 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:
|
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)
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1160.253
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Förmaksflimmer
-
Pusan National University HospitalHar inte rekryterat ännuHjärtimplanterbar elektronisk enhet | Atrial High Rate EpisodKorea, Republiken av
-
Atrial Fibrillation NetworkDaiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company; Deutsches Zentrum...AvslutadAtrial High Rate EpisoderÖsterrike, Belgien, Bulgarien, Tjeckien, Frankrike, Tyskland, Grekland, Ungern, Italien, Nederländerna, Polen, Portugal, Rumänien, Spanien, Sverige, Ukraina, Storbritannien, Danmark
-
Centre Chirurgical Marie LannelongueRekryteringMedfödd hjärtsjukdom | Sinus Venosus Defekt | Sinus Venosus Atrial Septum DefektFrankrike
-
Assiut UniversityIndragenASD2 (Secundum Atrial Septal Defect)
-
Karolinska InstitutetDanderyd HospitalRekryteringFörmaksflimmer | Förmaksfladder | Supraventrikulärt slag, för tidigt | För tidiga supraventrikulära beats | För tidigt förmakskomplex | Extrasystole, AtrialSverige