START-Register: Survey on Anticoagulated Patients Register
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.
Heart Valve Diseases or Prosthesis
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||1 Year|
|Official Title:||Phase 4 Study on Clinical History of Patients Who Start a Chronic Anticoagulant Treatment|
- incidence of complications (number per cent patient-years of treatment) [ Time Frame: at 1 year of follow-up ] [ Designated as safety issue: No ]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.
- Percentage of Time in the therapeutic range (TTR) [ Time Frame: at 1 year ] [ Designated as safety issue: No ]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
- percentage of patients who stop anticoagulant treatment [ Time Frame: at 1 year ] [ Designated as safety issue: No ]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
Biospecimen Retention: Samples Without DNA
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||July 2019|
|Estimated Primary Completion Date:||November 2018 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02219984
|S. Orsola-Malpighi University hospital|
|Bologna, BO, Italy, 40138|