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| Name | Class |
|---|---|
| Arianna Anticoagulazione Foundation | OTHER |
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This is a phase 4 cohort prospective, open, national, multicentre study that collects data on history of patients treated chronically with anticoagulant drugs, including the novel direct oral anticoagulants (DOACs). The Registry is designed solely for observational purposes and is not intended to have any influence on the treatment of the single patients included.
Patients are included when they start the anticoagulant treatment, whatever the drug used, or when they shift from a vitamin K antagonist (VKA) drug to one of the novel direct oral anticoagulants, provided that the therapy is expected to last at least 3 months.
The general aims of the study are to provide a better evaluation of efficacy and safety of different treatment options, and to improve our understanding of the risks/benefits of the various anticoagulant drugs and the different therapy options.
The Registry is open to the participation of clinical centres or individual professionals (now called Participants) that are involved with management of anticoagulated patients.
Participants can include patients with 18 years or more who satisfy the following preset criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients anticoagulated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anticoagulants | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of complications (number per cent patient-years of treatment) | from date of inclusion in the registry until the date of first documented major complication or date of death from any cause, whichever came first, assessed up to 5 years. | at 1 year of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time in the therapeutic range (TTR) | This only applies to patients who receive VKAs for treatment; from date of inclusion in the registry until the date of VKA treatment was stopped, or date of death from any cause, whichever came first, assessed up to 5 years | at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients who stop anticoagulant treatment | This applies only to patients anticoagulated for atrial fibrillation; from date of inclusion in the registry until the date anticoagulant treatment was discontinued, or date of death from any cause, whichever came first, assessed up to 5 years | at 1 year |
Inclusion Criteria:
Exclusion Criteria:
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Are included in the Registry patients who need chronic anticoagulation for atrial fibrillation, or venous thromboembolism, or heart valve diseases or prosthesis, or other clinical conditions requiring anticoagulation.
For the sampling method, participants are instructed to choose and declare one modality of inclusion for VKA treated patients: one week per month, or one day per week (always the same), etc. For patients treated with DOACs (low number in our country) it is recommended to include all patients progressively
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gualtiero Palareti, MD | Contact | + 328 2279868 | gualtiero.palareti@unibo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S. Orsola-Malpighi University hospital | Recruiting | Bologna | BO | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41182346 | Derived | Menichelli D, Gazzaniga G, Poli D, Palareti G, Antonucci E, Pani A, Pignatelli P, Pastori D; START2 Register Investigators. Real-world use of direct oral anticoagulants in atrial fibrillation patients with moderate/severe chronic kidney disease: a propensity score matched analysis from the START registry. Clin Res Cardiol. 2025 Nov 3. doi: 10.1007/s00392-025-02765-7. Online ahead of print. | |
| 40519207 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D054556 | Venous Thromboembolism |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000925 | Anticoagulants |
| ID | Term |
|---|---|
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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plasma samples for measurements of anticoagulant drug activity
| Derived |
| Menichelli D, Antonucci E, Gazzaniga G, Poli D, Armentaro G, di Carlo G, Marcucci R, Calabro P, Cesaro A, Palareti G, Sciacqua A, Pignatelli P, Pastori D; START 2 Collaborators *. Atrial Fibrillation, Heart Failure Phenotypes, and Mortality Risk in the Nationwide START Registry: A Propensity Score Matching Analysis. J Am Heart Assoc. 2025 Jun 17;14(12):e042586. doi: 10.1161/JAHA.125.042586. Epub 2025 Jun 16. |
| 26001109 | Derived | Antonucci E, Poli D, Tosetto A, Pengo V, Tripodi A, Magrini N, Marongiu F, Palareti G; START-Register. The Italian START-Register on Anticoagulation with Focus on Atrial Fibrillation. PLoS One. 2015 May 22;10(5):e0124719. doi: 10.1371/journal.pone.0124719. eCollection 2015. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |