START-Register: Survey on Anticoagulated Patients Register

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by St. Orsola Hospital
Sponsor:
Information provided by (Responsible Party):
GUALTIERO PALARETI, St. Orsola Hospital
ClinicalTrials.gov Identifier:
NCT02219984
First received: August 12, 2014
Last updated: August 16, 2014
Last verified: August 2014
  Purpose

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 Intervention
Atrial Fibrillation
Venous Thromboembolism
Heart Valve Diseases or Prosthesis
Other Heart or Peripheral Vascular Diseases Leading to Chronic Anticoagulation
Drug: Anticoagulants
Drug: anticoagulants

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

Resource links provided by NLM:


Further study details as provided by St. Orsola Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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

plasma samples for measurements of anticoagulant drug activity


Estimated Enrollment: 10000
Study Start Date: October 2011
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patients anticoagulated Drug: Anticoagulants Drug: anticoagulants
Other Names:
  • warfarin
  • acenocoumarol
  • LMWH
  • dabigatran
  • rivaroxaban
  • apixaban
  • edoxaban

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

  • age >= 18 years

Exclusion Criteria:

  • < 18 years
  • not willing to sign informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02219984

Contacts
Contact: Gualtiero Palareti, MD + 328 2279868 gualtiero.palareti@unibo.it

Locations
Italy
S. Orsola-Malpighi University hospital Recruiting
Bologna, BO, Italy, 40138
Contact: Serena Zorzi    +39 051 636 ext 2482    angiologia@aosp.bo.it   
Principal Investigator: Giuliana Guazzaloca, MD         
Sponsors and Collaborators
St. Orsola Hospital
  More Information

No publications provided

Responsible Party: GUALTIERO PALARETI, Professor in Vascular Medicine, St. Orsola Hospital
ClinicalTrials.gov Identifier: NCT02219984     History of Changes
Other Study ID Numbers: 142/2010/O/Oss
Study First Received: August 12, 2014
Last Updated: August 16, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by St. Orsola Hospital:
Anticoagulation
vitamin K antagonists
Warfarin
low molecular weight heparin
fondaparinux
antithrombotics
Direct oral anticoagulants
dabigatran
rivaroxaban
apixaban
edoxaban
atrial fibrillation
venous thromboembolism

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Valve Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Thromboembolism
Vascular Diseases
Venous Thromboembolism
Venous Thrombosis
Arrhythmias, Cardiac
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Embolism and Thrombosis
Heart Diseases
Pathologic Processes
Thrombosis
Anticoagulants
Rivaroxaban
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014