NCT02219984|RecruitingDMC
START-Register: Survey on Anticoagulated Patients Register
Phase 4 Study on Clinical History of Patients Who Start a Chronic Anticoagulant Treatment
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Phase 4 Study on Clinical History of Patients Who Start a Chronic Anticoagulant Treatment
Sponsor study identifier
observational
15,410
1 country
1
Study Start
October 2011
Actual (reported)Primary Completion
July 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2011
Actual (reported)August 12, 2014
Actual (reported)August 19, 2014
Actual (reported)July 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Percentage of Time in the therapeutic range (TTR)
at 1 year
percentage of patients who stop anticoagulant treatment
at 1 year
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
S. Orsola-Malpighi University hospital
Bologna, BO, 40138, Italy
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.
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.
plasma samples for measurements of anticoagulant drug activity
First Submitted
August 12, 2014
First Posted
August 19, 2014
Study Start
October 2011
Actual (reported)Primary Completion
July 2025
Estimated (date passed)DOCE Study Interaction Between Direct Oral Anticoagulants and Drug-metabolizing Enzyme Inducers
Contact the study team to confirm eligibility.
De Sio V, Gragnano F, Capolongo A, Guarnaccia N, Maddaluna P, Acerbo V, Galli M, Berteotti M, Sperlongano S, Cesaro A, Moscarella E, Pelliccia F, Patti G, Antonucci E, Cirillo P, Pignatelli P, Palareti G, Pengo V, Gresele P, Marcucci R, Calabro P. Eligibility for and practical implications of Semaglutide in overweight and obese patients with acute coronary syndrome. Int J Cardiol. 2025 Mar 15;423:133028. doi: 10.1016/j.ijcard.2025.133028. Epub 2025 Jan 29.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 2, 2023
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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