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START-Register: Survey on Anticoagulated Patients Register

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02219984
Recruitment Status : Recruiting
First Posted : August 19, 2014
Last Update Posted : March 17, 2020
Information provided by (Responsible Party):

Brief 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). 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.

Condition or disease Intervention/treatment
Atrial Fibrillation Venous Thromboembolism Heart Valve Diseases or Prosthesis Drug: Anticoagulants

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 15410 participants
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
Actual Study Start Date : October 2011
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort Intervention/treatment
patients anticoagulated Drug: Anticoagulants

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Percentage of Time in the therapeutic range (TTR) [ Time Frame: at 1 year ]
    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

Other Outcome Measures:
  1. percentage of patients who stop anticoagulant treatment [ Time Frame: at 1 year ]
    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
plasma samples for measurements of anticoagulant drug activity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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


Inclusion Criteria:

  • age >= 18 years

Exclusion Criteria:

  • < 18 years
  • not willing to sign informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02219984

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Contact: Gualtiero Palareti, MD + 328 2279868

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S. Orsola-Malpighi University hospital Recruiting
Bologna, BO, Italy, 40138
Contact: Emilia Antonucci    +39 051 4291116   
Principal Investigator: Benilde Cosmi, MD         
Sponsors and Collaborators
St. Orsola Hospital
Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: GUALTIERO PALARETI, Professor in Vascular Medicine, St. Orsola Hospital Identifier: NCT02219984    
Other Study ID Numbers: 142/2010/O/Oss
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by GUALTIERO PALARETI, St. Orsola Hospital:
vitamin K antagonists
low molecular weight heparin
Direct oral anticoagulants
atrial fibrillation
venous thromboembolism
Additional relevant MeSH terms:
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Atrial Fibrillation
Venous Thromboembolism
Heart Valve Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases