Integrated Approach in Frail Older People with Atrial Fibrillation (AFFIRMO)
AFFIRMO - Atrial Fibrillation Integrated Approach in Frail, Multimorbid and Polymedicated Older People
The study will verify if a structured multidisciplinary approach (called iABC), aimed to improve the appropriate management of elderly AF patients with multimorbidity (the i-ABC group), would provide a clear evidence of an improvement in clinical conditions and quality of life compared to usual clinical care. The i-ABC group in AFFIRMO will follow the ABC pathway, focused on three domains: avoid stroke with anticoagulation (with optimized VKA or label-adherent DOAC use); better symptom management; and optimized management of associated cardiovascular and non cardiovascular comorbidities.
The study will be conducted in Bulgaria, Denmark, Italy, Romania, Serbia and Spain .
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Controlled study, testing a structured implementation of an appropriate management of elderly AF patients with multimorbidity in clinical practice (adapting the ABC pathway and integrating the means of CGA) versus usual care; it is designed to provide reliable evidence of an active holistic integrated management approach to a common, multimorbid and 'high risk' clinical condition.
AFFIRMO use a novel platform (iABC) in a cluster randomized trial design, randomizing centres to iABC versus usual care.
Centres will be selected in each participating country (Bulgaria, Denmark, Italy, Romania, Serbia and Spain) under the responsibility of National Coordinators on the basis of a demonstrated interest in managing patients with AF. The 8-10 participating clusters in each country (see study size below) will be randomized in a 1:1 ratio to receive a quality-improvement intervention (iABC, experimental group) or 'usual care' practice (control group). The randomization will occur in each Country once all clusters selected in the Country have obtained IRB approval. The allocation schedule for random assignment of care models (iABC or usual care) to sites will be computer generated at the Central Coordinating Centre. The clusters in each Country will be stratified in 2 groups: Centres with or without interventional electrophysiology laboratory for AF ablation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aldo P Maggioni, MD
- Phone Number: +390555101211
- Email: affirmo@heartcarefoundation.it
Study Locations
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Haskovo, Bulgaria
- Recruiting
- MHAT Haskovo AD-Cardiology
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Contact:
- ANTONY GOGOV, MD
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Pernik, Bulgaria
- Recruiting
- SHATS Sveti Georgi - Pernik-Cardiology
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Contact:
- KOSTADIN KICHUKOV, MD
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Plovdiv, Bulgaria
- Recruiting
- MBAL Sv. Ivan Rilski-Cardiology
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Contact:
- KRASTYU PENCHEV, MD
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Plovdiv, Bulgaria
- Recruiting
- UMBAL Sveti Georgi EAD-Clinic of Cardiology
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Contact:
- MARIYA TOKMAKOVA, MD
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Plovdiv, Bulgaria
- Recruiting
- UMHAT Pulmed Plovdiv-Cardiology
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Contact:
- VLADIMIR IVANOV, MD
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Sofia, Bulgaria
- Recruiting
- Acibadem City Clinic Tokuda Hospital-Dept of Electrophysiology Clinic of Cardiology
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Contact:
- VASSIL TRAYKOV, MD
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Sofia, Bulgaria
- Recruiting
- Acibadem City Clinic UMBAL Cardiovascular Center-CARDIOLOGY
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Contact:
- ISKREN GARVANSKI, MD
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Sofia, Bulgaria
- Recruiting
- National Heart Hospital-ICCU
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Contact:
- ELENA KOSTOVA-DIMITROVA, MD
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Herlev, Denmark
- Recruiting
- Herlev Hospital-Department of Cardiology
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Contact:
- MORTEN K LAMBERTS, MD
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Hjoerring, Denmark
- Recruiting
- North Denmark Regional Hospital-Department of Cardiology
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Contact:
- ALBERT MARNI JOENSEN, MD
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Horsens, Denmark
- Recruiting
- Horsens Regional Hospital-Department of Medicine
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Contact:
- KAREN KAAE DODT, MD
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Silkeborg, Denmark
- Recruiting
- Silkeborg Regional Hospital-Diagnostic Centre, University Clinic for Development of Innovative Patient Pathways
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Contact:
- LARS FROST, MD
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Napoli, Italy, 80131
- Recruiting
- Aou Federico Ii-Medicina Metabolico-Riabilitativa
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Contact:
- Alberto Maria Marra, MD
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CE
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Caserta, CE, Italy, 81100
- Recruiting
- Azienda Ospedaliera S. Anna E S. Sebastiano-Cardiologia Clinica Universitaria
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Contact:
- Paolo Calabro', MD
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FI
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Firenze, FI, Italy, 50122
- Recruiting
- Ospedale Santa Maria Nuova-Cardiologia - Firenze 1
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Contact:
- Alessandro Paoletti Perini
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GE
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Genova, GE, Italy, 16100
- Recruiting
- Als Genovese Palazzo Della Salute-Cardiologia Quarto
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Contact:
- Maria Luisa Biorci, MD
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GR
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Grosseto, GR, Italy, 58100
- Recruiting
- Ospedale Della Misericordia-U.O. Di Cardiologia
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Contact:
- Luigi Addonisio, MD
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MB
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Monza, MB, Italy, 20900
- Recruiting
- Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia
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Contact:
- Elena Pazzi, MD
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MI
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Milano, MI, Italy, 20138
- Recruiting
- Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano-Uo Cure Subacute
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Contact:
- Marco Proietti, MD
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PC
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Piacenza, PC, Italy, 29100
- Recruiting
- Ospedale Civile 'Guglielmo Da Saliceto'-Uoc Cardiologia E Utic
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Contact:
- Daniela Aschieri, MD
- Phone Number: +390523303209
- Email: d.aschieri@ausl.pc.it
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PG
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Gubbio, PG, Italy, 06024
- Recruiting
- Ospedale Gubbio-Gualdo Tadino-U.O. Di Utic E Cardiologia
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Contact:
- Deborah Cosmi, MD
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RM
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Roma, RM, Italy, 00161
- Recruiting
- Policlinico Umberto Primo-Medicina Interna E Immunologia Clinica
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Contact:
- Stefania Basili, MD
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TR
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Terni, TR, Italy, 05100
- Recruiting
- Azienda Ospedaliera Santa Maria-Medicina Interna
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Contact:
- Giacomo Pucci, MD
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UD
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Udine, UD, Italy, 33100
- Recruiting
- Pou "Santa Maria Della Misericordia"-S.O.C. Cardiologia
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Contact:
- Marzia De Biasio, MD
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Bucuresti, Romania
- Recruiting
- Spitalul Clinic Colentina-Cardiology
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Contact:
- ANCA RODICA DAN, MD
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Bucuresti, Romania
- Recruiting
- Spitalul Clinic Colentina-Internal Medicine
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Contact:
- CRISTIAN RASVAN BAICUS, MD
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Bucuresti, Romania
- Recruiting
- Spitalul Clinic Coltea-Internal Medicine and Cardiology
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Contact:
- ILINCA MIHAELA SAVULESCU-FIEDLER, MD
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Bucuresti, Romania
- Recruiting
- Spitalul Clinic de Urgenta 'Bagdasar-Arseni'-Cardiology
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Contact:
- CRINA SINESCU, MD
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Bucuresti, Romania
- Recruiting
- Spitalul Clinic de Urgenta Bucuresti-Cardiology
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Contact:
- ALEXANDRU SCAFA-UDRISTE, MD
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Bucuresti, Romania
- Recruiting
- Spitalul Clinic Prof.Dr.Th.Burghele-Internal Medicine and Cardiology
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Contact:
- ANA MARIA BALAHURA, MD
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Bucuresti, Romania
- Recruiting
- Spitalul Universitar de Urgenta Elias-Cardiology
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Contact:
- SERBAN BALANESCU, MD
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Bucuresti, Romania
- Recruiting
- Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila-Cardiac Function Laboratory
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Contact:
- SILVIU STANCIU, MD
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Belgrade, Serbia
- Recruiting
- Institute for Cardiovascular Diseases Dedinje-Pacemaker and electrophysiology department
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Contact:
- DEJAN KOJIC, MD
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Belgrade, Serbia
- Recruiting
- KBC Bezanijska Kosa-Cardiology Department
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Contact:
- MARIJA ZDRAVKOVIC, MD
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Belgrade, Serbia
- Recruiting
- KBC Zemun-Cardiology Department
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Contact:
- RADOSAV VIDAKOVIC, MD
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Belgrade, Serbia
- Recruiting
- University Clinical Centre of Serbia-Department for cardiac arrhythmias
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Contact:
- TATJANA POTPARA, MD
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Belgrade, Serbia
- Recruiting
- University Clinical Centre of Serbia-Department for invasive electrophysiology
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Contact:
- NEBOJSA MUJOVIC, MD
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Belgrade, Serbia
- Recruiting
- University Clinical Centre of Serbia-Emergency centre
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Contact:
- TANJA JOZIC, MD
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Kragujevac, Serbia
- Recruiting
- University Clinical Centre of Kragujevac-Cardiology Department
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Contact:
- STEFAN SIMOVIC, MD
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NIS, Serbia
- Recruiting
- University Clinical Centre of Nis-Cardiology Department
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Contact:
- TOMISLAV KOSTIC, MD
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Alicante, Spain
- Recruiting
- Hospital General Universitario de Alicante Doctor Balmis-CARDIOLOGY
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Contact:
- AMAYA GARCÍA-FERNÁNDEZ, MD
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Cartagena, Spain
- Recruiting
- Hospital General Universitario Santa Lucía-CARDIOLOGY
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Contact:
- IGNACIO GIL-ORTEGA, MD
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Cartama, Spain
- Recruiting
- Hospital Valle del Guadalhorce-CARDIOLOGY
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Contact:
- JORGE RODRÍGUEZ CAPITÁN, MD
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Elche, Spain
- Recruiting
- Hospital General Universitario de Elche-CARDIOLOGY
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Contact:
- ANTONIO GARCÍA-HONRUBIA, MD
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Malaga, Spain
- Recruiting
- Hospital Universitario Virgen de la Victoria-CARDIOLOGY
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Contact:
- ALEJANDRO ISIDORO PÉREZ CABEZA, MD
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Murcia, Spain
- Recruiting
- Hospital Clínico Universitario Virgen de la Arrixaca-CARDIOLOGÍA
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Contact:
- FRANCISCO MARIN, MD
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Murcia, Spain
- Recruiting
- Hospital General Universitario Reina Sofía-CARDIOLOGY
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Contact:
- TOMÁS VICENTE VERA, MD
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Sant Joan D'alacant, Spain
- Recruiting
- Hospital Universitario San Juan de Alicante-CARDIOLOGY
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Contact:
- JOSE MORENO ARRIBAS, MD
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Tarragona, Spain
- Recruiting
- Hospital Universitario de Tarragona Joan XXIII-Cardiology
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Contact:
- JOSÉ LUÍS FERREIRO-GUTIÉRREZ, MD
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Valls, Spain
- Recruiting
- Pius Hospital de Valls-Cardiology
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Contact:
- LEYDIMAR ADEL ANMAD SHIHADEH MUSA, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Outpatients of both sexes with age ≥65 years;
- First diagnosed, paroxysmal, persistent, long-standing persistent or permanent AF, confirmed as per guideline-recommended diagnostic criteria for AF, e.g. with electrocardiogram (ECG) or Holter monitoring;
- ≥1 additional long-term comorbidity, thus fulfilling the definition of multimorbidity: hypertension (treated with at least 2 antihypertensive drugs), coronary artery disease (CAD), peripheral artery disease, heart failure, stroke/TIA, diabetes mellitus, COPD, CKD.
Exclusion Criteria:
- Mechanical prosthetic heart valve or moderate/severe mitral stenosis;
- Patient unwilling to be enrolled and sign written informed consent;
- Patient unable to understand the study and attend the follow-up;
- Serious diseases with a life expectancy inferior to 12 months;
- Patients included in other interventional studies.
Only for sites randomized to the iABC group:
- Patient without a device suitable for iABC use.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Quality-improvement intervention (iABC)
The novel platform (iABC) that will be used in AFFIRMO will consist of an educational program, a healthy or functional diet/physical activity, guideline-adherent drug treatments, periodic (re)assessment. iABC will provide guidance to obtain a more personalized care to AF patients in the experimental cluster implementing specific strategies to obtain clinical control for all the three pillars of the ABC pathway. During the entire follow-up the physician will be able to check the data imputed by the patients and, eventually, contact the patient to provide recommendations and to discuss changes to the treatments and lifestyle habits. |
The novel platform (iABC) that will be used in AFFIRMO will consist of an educational program, a healthy or functional diet/physical activity, guideline-adherent drug treatments, periodic (re)assessment.
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No Intervention: Usual care
Patients followed in the centers randomized to the control arm will be managed by usual care in accordance with local clinical guidance
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of iABC on all cause unplanned hospitalization
Time Frame: 12 months
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All-cause unplanned hospitalization
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of iABC on the composite endpoint of non ischemic stroke, transient ischemic attack and cardiovascular death
Time Frame: 12 months
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A 'composite endpoint' of nonfatal ischemic stroke, transient ischemic attack, and cardiovascular death
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12 months
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Impact of iABC on secondary outcome measures
Time Frame: 12 months
|
all-cause mortality
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12 months
|
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Impact of iABC on secondary outcome measures
Time Frame: 12 months
|
all-cause mortality and all-cause (planned and unplanned) hospitalizations
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12 months
|
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Impact of iABC on secondary outcome measures
Time Frame: 12 months
|
new diagnosis of HF or worsening HF requiring hospitalizations
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12 months
|
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Impact of iABC on secondary outcome measures
Time Frame: 12 months
|
quality of life assessed with EQ-5D-5L questionnaire
|
12 months
|
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Impact of iABC on secondary outcome measures
Time Frame: 12 months
|
major bleeds defined according to the ISTH definitions
|
12 months
|
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Impact of iABC on secondary outcome measures
Time Frame: 12 months
|
intracranial bleeds
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12 months
|
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Impact of iABC on secondary outcome measures
Time Frame: 12 months
|
occurrence of renal dysfunction or worsening renal function
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12 months
|
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Level of adherence to iABC pathway
Time Frame: 12 months
|
Level of adherence to iABC pathway will be evaluated by:
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12 months
|
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Impact of iABC on self reported physical activity
Time Frame: 12 months
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Impact of iABC on self reported physical activity
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12 months
|
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Level of empowerment and engagement of patient assessed with PHE-S questionnaire
Time Frame: 12 months
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Level of empowerment and engagement of patient assessed with PHE-S questionnaire
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12 months
|
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Therapy adherence
Time Frame: 12 months
|
Will be evaluated by persistence medical treatment at 12 month follow-up as reported in the e-CRF
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Arrhythmias, Cardiac
- Brain Ischemia
- Atherosclerosis
- Arteriosclerosis
- Arterial Occlusive Diseases
- Ischemic Attack, Transient
- Atrial Fibrillation
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
Other Study ID Numbers
- K23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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