Atrial FibrillationNCT02219984
START-Register: Survey on Anticoagulated Patients Register
An observational study of Atrial Fibrillation and Venous Thromboembolism, run by GUALTIERO PALARETI at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Venous Thromboembolism, Heart Valve Diseases or Prosthesis
- What is being tested?
- Anticoagulants
- How many people
- 15,410 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2011to Nov 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- age >= 18 years
Who cannot join
- < 18 years
- not willing to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
S. Orsola-Malpighi University hospital
Bologna, BO, 40138
Emilia Antonucci, +39 051 4291116, e.antonucci@fondazionearianna.org
Benilde Cosmi, MD
About this study
Official title: Phase 4 Study on Clinical History of Patients Who Start a Chronic Anticoagulant Treatment
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.
Read more
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.
Read the detailed description
Participants can include patients with 18 years or more who satisfy the following preset criteria:
- Participants should included patients consecutively to avoid selection bias; criteria to avoid selection bias are proposed to Participants, which should decide the one they want to adopt.
- Patients should have been receiving anticoagulation therapy for no more than 30 days at the time of inclusion, regardless of age, clinical indication for treatment, therapeutic range expected (in cases of treatment with VKAs) and expected duration of the treatment (providing a duration of at least 3 months is foreseen). Patients who have already been receiving chronic anticoagulation therapy for some time may be included if they are switched from VKAs to DOACs or to low molecular weight heparin or to fondaparinux
- Patients not prepared to undergo constant monitoring at their enrolling centres or who take part in phase II or III clinical studies should not be included. Patients who participate in other observational or phase IV studies can be included in the Register.
- All patients must give their informed written consent -- following procedures laid down by local Ethical Committees - for the compilation and conservation on the Register's central database of data regarding their personal clinical histories and anticoagulation treatment patterns and for use of said data.
- All the patients inserted must be followed for at least 1 year, even though an indefinite follow-up of all patients continuing anticoagulation therapy is highly recommended. If in single patients anticoagulation treatment is discontinued within 1 year of inclusion, active participating members should nonetheless keep on compiling (telephonically too) information regarding the possible onset of complications (thrombotic, bleeding clinical events of another nature) till 1 year -follow-up.
- The Participants of the Register must use a computer programme as database - for all the information to be collected. The computer programme must meet the features requested by the Executive Committee of the Registry and must be able to send the information to the centralised database via internet and connection to the web site. By way of alternative the Participants can use the "Simple-START" software provided free by the Registry.
- As criterion for safeguarding the privacy of patients, every patient inserted in the Registry is identified by a "Patient log" which includes the identification code of the enrolling Participant and the identification code of each single patient, using the computer database programme used by the Participant. The enrolling Participant is committed to keeping for the whole duration of the Register the whole demographic data of each patient associated with the Patient log".
- Are excluded patients who: have < 18 years age, are not willing to sign informed consent, are not ready to submit to constant monitoring, participate in phase II or III clinical studies
- Follow-Up All the patients inserted must be followed for at least 1 year even though an indefinite follow up of all patients continuing anticoagulation therapy is strongly recommended. If anticoagulation therapy is interrupted in single patients within 1 year of insertion the Participants must still continue to collect (even telephonically) data regarding the possible onset of complications (thrombotic, bleeding or other clinical events) for 1 year of follow-up.
- Being tested
- Anticoagulants
- Keywords
- Anticoagulation, vitamin K antagonists, Warfarin, low molecular weight heparin, fondaparinux, antithrombotics, Direct oral anticoagulants, dabigatran, rivaroxaban, apixaban, edoxaban, atrial fibrillation, venous thromboembolism
- Medical subject headings
- Atrial Fibrillation, Venous Thromboembolism, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnticoagulantsDrug
| Study group | Role | What they receive |
|---|---|---|
| patients anticoagulated | Not described Receives: Drug: Anticoagulants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 1 year of follow-up
Secondary outcomes (1)
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
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startOct 2011
- Primary completionJul 2025 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,410 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- GUALTIERO PALARETI
- Sponsor type
- University, hospital or other
- Collaborators
- Arianna Anticoagulazione Foundation
- Responsible party
- Sponsor-investigator, GUALTIERO PALARETI, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219984
- Sponsor's protocol ID
- 142/2010/O/Oss
- Status last verified
- Feb 2023
- First submitted
- 12 Aug 2014
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 41182346Menichelli 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.
PubMed 40519207De 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.
PubMed 39890028Antonucci 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.
PubMed 26001109
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study on Clinical History of Patients Who Start a Chronic Anticoagulant Treatment
- ClinicalTrials.gov ID
- NCT02219984
- Acronym / sponsor ID
- 142/2010/O/Oss
- Keywords
- Anticoagulation, vitamin K antagonists, Warfarin, low molecular weight heparin, fondaparinux, antithrombotics, Direct oral anticoagulants, dabigatran
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,410 participants (estimated)
- Lead sponsor
- GUALTIERO PALARETIUniversity, hospital or other
- Collaborators
- Arianna Anticoagulazione Foundation
- Study start
- Oct 2011 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants can include patients with 18 years or more who satisfy the following preset criteria:
- Participants should included patients consecutively to avoid selection bias; criteria to avoid selection bias are proposed to Participants, which should decide the one they want to adopt.
- Patients should have been receiving anticoagulation therapy for no more than 30 days at the time of inclusion, regardless of age, clinical indication for treatment, therapeutic range expected (in cases of treatment with VKAs) and expected duration of the treatment (providing a duration of at least 3 months is foreseen). Patients who have already been receiving chronic anticoagulation therapy for some time may be included if they are switched from VKAs to DOACs or to low molecular weight heparin or to fondaparinux
- Patients not prepared to undergo constant monitoring at their enrolling centres or who take part in phase II or III clinical studies should not be included. Patients who participate in other observational or phase IV studies can be included in the Register.
- All patients must give their informed written consent -- following procedures laid down by local Ethical Committees - for the compilation and conservation on the Register's central database of data regarding their personal clinical histories and anticoagulation treatment patterns and for use of said data.
- All the patients inserted must be followed for at least 1 year, even though an indefinite follow-up of all patients continuing anticoagulation therapy is highly recommended. If in single patients anticoagulation treatment is discontinued within 1 year of inclusion, active participating members should nonetheless keep on compiling (telephonically too) information regarding the possible onset of complications (thrombotic, bleeding clinical events of another nature) till 1 year -follow-up.
- The Participants of the Register must use a computer programme as database - for all the information to be collected. The computer programme must meet the features requested by the Executive Committee of the Registry and must be able to send the information to the centralised database via internet and connection to the web site. By way of alternative the Participants can use the "Simple-START" software provided free by the Registry.
- As criterion for safeguarding the privacy of patients, every patient inserted in the Registry is identified by a "Patient log" which includes the identification code of the enrolling Participant and the identification code of each single patient, using the computer database programme used by the Participant. The enrolling Participant is committed to keeping for the whole duration of the Register the whole demographic data of each patient associated with the Patient log".
- Are excluded patients who: have < 18 years age, are not willing to sign informed consent, are not ready to submit to constant monitoring, participate in phase II or III clinical studies
- Follow-Up All the patients inserted must be followed for at least 1 year even though an indefinite follow up of all patients continuing anticoagulation therapy is strongly recommended. If anticoagulation therapy is interrupted in single patients within 1 year of insertion the Participants must still continue to collect (even telephonically) data regarding the possible onset of complications (thrombotic, bleeding or other clinical events) for 1 year of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients anticoagulated | – | Drug: Anticoagulants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (1 listed)
- age >= 18 years
Key exclusion criteria (2 listed)
- < 18 years
- not willing to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticoagulants | Drug | patients anticoagulated |
Primary outcome
incidence of complications (number per cent patient-years of treatment)
Time frame: at 1 year of follow-up
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.
1 secondary outcome
Percentage of Time in the therapeutic range (TTR)
Time frame: at 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Derived from this study: PubMed 41182346Menichelli 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.
- Derived from this study: PubMed 40519207Menichelli 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.
- Derived from this study: PubMed 39890028De 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.
- Derived from this study: PubMed 26001109Antonucci 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Venous Thromboembolism, run by GUALTIERO PALARETI at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gualtiero Palareti, MD (+ 328 2279868, gualtiero.palareti@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of complications (number per cent patient-years of treatment) (time frame: at 1 year of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02219984, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.