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出境医 / 临床实验 / The Portuguese Survey on Anticoagulated Patients Register (START-Portugal-Register) (START-Portugal)

The Portuguese Survey on Anticoagulated Patients Register (START-Portugal-Register) (START-Portugal)

Study Description
Brief Summary:

Anticoagulants are used to prevent thrombotic events in patients with predisposing factors. However, the use of such therapies is associated with bleeding complications, which can be a serious safety issue. Thus, it is important to evaluate the safety and effectiveness of such therapies based on data collected in clinical practice in order to generate relevant scientific data that could be used to support clinical and regulatory decisions.

This is an open, prospective, multicenter, observational cohort study that aims to prospectively record the clinical history of adult patients receiving anticoagulant treatment, irrespectively of the prescribed drug and the indication for its use.


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

Detailed Description:
  • The Portuguese Survey on anTicoagulated pAtients RegisTer (START-Portugal-Register) is an open, prospective, multicenter, observational cohort study that intends to record the clinical history of adult patients receiving anticoagulant therapies, providing real-world data on the safety and effectiveness of such therapies, as well as to serve as the starting point of collaborative clinical studies, enabling their planning and execution.
  • The START-Portugal-Register is designed solely for observational purposes; it is not intended to have any influence on the treatment of included patients.

  • Objectives:

    • To prospectively record the clinical history of adult patients receiving anticoagulant treatment, irrespectively of the prescribed drug and the indication for its use.
    • To enhance the understanding of risks and benefits associated with the use of anticoagulant drugs in routine clinical practice;
    • To prospectively record decisions and reasons guiding physicians' decisions in order to manage anticoagulant treatment options in routine clinical practice;
    • To improve knowledge on the epidemiologic, diagnostic and clinical features of thrombotic diseases;
    • To generate real-world evidence on the safety and effectiveness of anticoagulant drugs, therefore contributing to support informed clinical decisions.
  • The START-Portugal-Register is open to the participation of clinical centers and individual physicians that are involved in the management of patients undergoing anticoagulant treatment.
  • Patients who sign the informed consent and fulfil the inclusion/exclusion criteria will be enrolled in the study and considered for data analysis.
  • Follow-up: mandatory for at least 12 months. Nevertheless, a long-term follow-up is recommended for patients who receive an indefinite anticoagulation treatment. The START-Portugal-Register sets itself an indefinite time limit.
  • A descriptive analysis will be conducted for all study variables. A propensity score model will be applied to compare the safety and efficacy of the different anticoagulant treatments.
Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: The Portuguese Survey on Anticoagulated Patients Register (START-Portugal-Register)
Actual Study Start Date : January 27, 2020
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2024
Arms and Interventions
Group/Cohort Intervention/treatment
Anticoagulated patients
Patients receiving anticoagulation treatment
 Drug: Anticoagulant drugs
Anticoagulant drugs
Outcome Measures
Primary Outcome Measures :
  1. Incidence of complications [ Time Frame: At least 12 months of follow-up ]
    From date of inclusion in the registry until the date of first documented complication or date of death from any cause, whichever came first.


Eligibility Criteria
Layout table for eligibility information
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
The START-Portugal-Register is open to the participation of clinical centers and individual physicians (called Participants) that are involved in the management of patients undergoing anticoagulant treatment. Participants are required to enroll patients consecutively, without any a-priori exclusion criteria other than life-expectancy,lack of availability for follow-up or geographical inaccessibility.
Criteria

Inclusion Criteria:

  • Aged ≥18 years;
  • Patients who, at the time of inclusion, have been receiving for no more than 30 days or are about to start anticoagulation therapy - irrespectively of the prescribed drug, the dosage, and the indication for its use;
  • Availability to sign an informed consent form.

Exclusion Criteria:

  • Not available for follow-up and constant monitoring;
  • Participation in phase II or III clinical studies*;
  • Life-expectancy <6 months, non-residents in the Participant region, or planning to leave in the next 6 months.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Francisco Batel Marques, PhD +351 239 480 138 batelmarques@aibili.pt
Contact: Diogo Mendes, PhD +351 239 480 138 dmendes@aibili.pt

Locations
Layout table for location information
Portugal
AIBILI - Association for Innovation and Biomedical Research on Light and Image Recruiting
Coimbra, Portugal
Contact: Joana Abrantes    +351 239 480 113    jrabrantes@aibili.pt   
Sponsors and Collaborators
CHAD
Investigators
Layout table for investigator information
Principal Investigator: Francisco Batel Marques, PhD AIBILI - Association for Innovation and Biomedical Research on Light and Image
Tracking Information
First Submitted Date June 5, 2019
First Posted Date June 6, 2019
Last Update Posted Date October 28, 2020
Actual Study Start Date January 27, 2020
Estimated Primary Completion Date July 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2019) 		Incidence of complications [ Time Frame: At least 12 months of follow-up ]
From date of inclusion in the registry until the date of first documented complication or date of death from any cause, whichever came first.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Portuguese Survey on Anticoagulated Patients Register (START-Portugal-Register)
Official Title The Portuguese Survey on Anticoagulated Patients Register (START-Portugal-Register)
Brief Summary

Anticoagulants are used to prevent thrombotic events in patients with predisposing factors. However, the use of such therapies is associated with bleeding complications, which can be a serious safety issue. Thus, it is important to evaluate the safety and effectiveness of such therapies based on data collected in clinical practice in order to generate relevant scientific data that could be used to support clinical and regulatory decisions.

This is an open, prospective, multicenter, observational cohort study that aims to prospectively record the clinical history of adult patients receiving anticoagulant treatment, irrespectively of the prescribed drug and the indication for its use.
Detailed Description
  • The Portuguese Survey on anTicoagulated pAtients RegisTer (START-Portugal-Register) is an open, prospective, multicenter, observational cohort study that intends to record the clinical history of adult patients receiving anticoagulant therapies, providing real-world data on the safety and effectiveness of such therapies, as well as to serve as the starting point of collaborative clinical studies, enabling their planning and execution.
  • The START-Portugal-Register is designed solely for observational purposes; it is not intended to have any influence on the treatment of included patients.

  • Objectives:

    • To prospectively record the clinical history of adult patients receiving anticoagulant treatment, irrespectively of the prescribed drug and the indication for its use.
    • To enhance the understanding of risks and benefits associated with the use of anticoagulant drugs in routine clinical practice;
    • To prospectively record decisions and reasons guiding physicians' decisions in order to manage anticoagulant treatment options in routine clinical practice;
    • To improve knowledge on the epidemiologic, diagnostic and clinical features of thrombotic diseases;
    • To generate real-world evidence on the safety and effectiveness of anticoagulant drugs, therefore contributing to support informed clinical decisions.
  • The START-Portugal-Register is open to the participation of clinical centers and individual physicians that are involved in the management of patients undergoing anticoagulant treatment.
  • Patients who sign the informed consent and fulfil the inclusion/exclusion criteria will be enrolled in the study and considered for data analysis.
  • Follow-up: mandatory for at least 12 months. Nevertheless, a long-term follow-up is recommended for patients who receive an indefinite anticoagulation treatment. The START-Portugal-Register sets itself an indefinite time limit.
  • A descriptive analysis will be conducted for all study variables. A propensity score model will be applied to compare the safety and efficacy of the different anticoagulant treatments.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The START-Portugal-Register is open to the participation of clinical centers and individual physicians (called Participants) that are involved in the management of patients undergoing anticoagulant treatment. Participants are required to enroll patients consecutively, without any a-priori exclusion criteria other than life-expectancy,lack of availability for follow-up or geographical inaccessibility.
Condition
  • Atrial Fibrillation
  • Venous Thromboembolism
  • Heart Valve Diseases or Prosthesis
Intervention Drug: Anticoagulant drugs
Anticoagulant drugs
Study Groups/Cohorts Anticoagulated patients
Patients receiving anticoagulation treatment
Intervention: Drug: Anticoagulant drugs
Publications *
  • Testa S, Paoletti O, Zimmermann A, Bassi L, Zambelli S, Cancellieri E. The role of anticoagulation clinics in the era of new oral anticoagulants. Thrombosis. 2012;2012:835356. doi: 10.1155/2012/835356. Epub 2012 Oct 14.
  • 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.
  • Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014 Mar 15;383(9921):955-62. doi: 10.1016/S0140-6736(13)62343-0. Epub 2013 Dec 4.
  • EINSTEIN-PE Investigators, Büller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF, Minar E, Chlumsky J, Verhamme P, Wells P, Agnelli G, Cohen A, Berkowitz SD, Bounameaux H, Davidson BL, Misselwitz F, Gallus AS, Raskob GE, Schellong S, Segers A. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012 Apr 5;366(14):1287-97. doi: 10.1056/NEJMoa1113572. Epub 2012 Mar 26.
  • Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, Baanstra D, Schnee J, Goldhaber SZ; RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009 Dec 10;361(24):2342-52. doi: 10.1056/NEJMoa0906598.
  • Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8.
  • Hokusai-VTE Investigators, Büller HR, Décousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31. Erratum in: N Engl J Med. 2014 Jan 23;370(4):390.
  • Caldeira D, Rodrigues FB, Barra M, Santos AT, de Abreu D, Gonçalves N, Pinto FJ, Ferreira JJ, Costa J. Non-vitamin K antagonist oral anticoagulants and major bleeding-related fatality in patients with atrial fibrillation and venous thromboembolism: a systematic review and meta-analysis. Heart. 2015 Aug;101(15):1204-11. doi: 10.1136/heartjnl-2015-307489. Epub 2015 Jun 2. Review.
  • Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 5, 2019) 		2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 1, 2024
Estimated Primary Completion Date July 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Aged ≥18 years;
  • Patients who, at the time of inclusion, have been receiving for no more than 30 days or are about to start anticoagulation therapy - irrespectively of the prescribed drug, the dosage, and the indication for its use;
  • Availability to sign an informed consent form.

Exclusion Criteria:

  • Not available for follow-up and constant monitoring;
  • Participation in phase II or III clinical studies*;
  • Life-expectancy <6 months, non-residents in the Participant region, or planning to leave in the next 6 months.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Francisco Batel Marques, PhD +351 239 480 138 batelmarques@aibili.pt
Contact: Diogo Mendes, PhD +351 239 480 138 dmendes@aibili.pt
Listed Location Countries Portugal
Removed Location Countries  
 
Administrative Information
NCT Number NCT03977363
Other Study ID Numbers CHAD-2019-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party CHAD, Association for Innovation and Biomedical Research on Light and Image
Study Sponsor CHAD
Collaborators Not Provided
Investigators
Principal Investigator: Francisco Batel Marques, PhD AIBILI - Association for Innovation and Biomedical Research on Light and Image
PRS Account Association for Innovation and Biomedical Research on Light and Image
Verification Date October 2020

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