START-Register: Survey on Anticoagulated Patients Register

NCT02219984 | Recruiting DMC

• 1 other identifier: 142/2010/O/Oss
• Study Type: observational
• Target: 15,410
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Venous Thromboembolism; Heart Valve Diseases or Prosthesis

Keywords

Anticoagulation; vitamin K antagonists; Warfarin; low molecular weight heparin; fondaparinux; antithrombotics; Direct oral anticoagulants; dabigatran; rivaroxaban; apixaban; edoxaban; atrial fibrillation; venous thromboembolism

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Percentage of Time in the therapeutic range (TTR)

  at 1 year

Other Outcomes (1)

• percentage of patients who stop anticoagulant treatment

  at 1 year

Study Arms (1)

patients anticoagulated

Drug: Anticoagulants

Interventions

Anticoagulants DRUG

patients anticoagulated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• age \>= 18 years

You may not qualify if:

• \< 18 years
• not willing to sign informed consent

Sponsors & Collaborators

• GUALTIERO PALARETI: lead
• Arianna Anticoagulazione Foundation: collaborator

Study Sites (1)

S. Orsola-Malpighi University hospital

Bologna, BO, 40138, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 41182346 DERIVED

• 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.

  PMID: 40519207 DERIVED

• 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.

  PMID: 26001109 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples for measurements of anticoagulant drug activity

MeSH Terms

Conditions

Atrial Fibrillation; Venous Thromboembolism; Heart Valve Diseases

Interventions

Anticoagulants

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Gualtiero Palareti, MD

CONTACT

+ 328 2279868; gualtiero.palareti@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in Vascular Medicine

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 19, 2014
• Study Start: October 1, 2011
• Primary Completion: July 1, 2025
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 2, 2023

Record last verified: 2023-02

Locations

IT (1)