Atrial FibrillationSTART-PortugalNCT03977363
The Portuguese Survey on Anticoagulated Patients Register (START-Portugal-Register)
An observational study of Atrial Fibrillation and Venous Thromboembolism, run by CHAD at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Venous Thromboembolism, Heart Valve Diseases or Prosthesis
- What is being tested?
- Anticoagulant drugs
- How many people
- 25 participants
- Where
- 1 sitePortugal
- Study dates
- 27 Jan 2020to 2 Mar 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
AIBILI - Association for Innovation and Biomedical Research on Light and Image
Coimbra
About this study
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.
Read the 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.
- Being tested
- Anticoagulant drugs
- Keywords
- Anticoagulation, Anticoagulants, Vitamin K antagonists, Warfarin, Low molecular weight heparin, Direct oral anticoagulants, dabigatran, rivaroxaban, apixaban, edoxaban, Atrial Fibrillation, Thromboembolism, Venous Thromboembolism, Heart Valve Diseases, Arrhythmia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Embolism and Thrombosis
- Medical subject headings
- Atrial Fibrillation, Venous Thromboembolism, Heart Valve Diseases, Thromboembolism, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulant drugsDrug
Anticoagulant drugs
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulated patients | Patients receiving anticoagulation treatment Receives: Drug: Anticoagulant drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications
From date of inclusion in the registry until the date of first documented complication or date of death from any cause, whichever came first.
Measured: At least 12 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start27 Jan 2020
- Primary completion2 Mar 2023
- Study completion2 Mar 2023
Why it stopped: Halted Prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- CHAD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CHAD, Association for Innovation and Biomedical Research on Light and Image
- Investigators
- Francisco Batel Marques, PhD, Principal investigator, AIBILI - Association for Innovation and Biomedical Research on Light and Image
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977363
- Sponsor's protocol ID
- CHAD-2019-01
- Acronym
- START-Portugal
- Status last verified
- May 2023
- First submitted
- 5 Jun 2019
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
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.
PubMed 23097696Antonucci 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.
PubMed 26001109Ruff 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.
PubMed 24315724EINSTEIN-PE Investigators; Buller 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.
PubMed 22449293Schulman 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.
PubMed 19966341Agnelli 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.
PubMed 23216615Hokusai-VTE Investigators; Buller HR, Decousus 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.
PubMed 23991658Caldeira D, Rodrigues FB, Barra M, Santos AT, de Abreu D, Goncalves 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.
PubMed 26037103Schulman 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. doi: 10.1111/j.1538-7836.2005.01204.x.
PubMed 15842354
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Portuguese Survey on Anticoagulated Patients Register (START-Portugal-Register)
- ClinicalTrials.gov ID
- NCT03977363
- Acronym / sponsor ID
- START-Portugal / CHAD-2019-01
- Keywords
- Anticoagulation, Anticoagulants, Vitamin K antagonists, Warfarin, Low molecular weight heparin, Direct oral anticoagulants, dabigatran, rivaroxaban
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Halted Prematurely
- Enrolment
- 25 participants (actual)
- Lead sponsor
- CHADUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anticoagulated patients | – | Drug: Anticoagulant drugsPatients receiving anticoagulation treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticoagulant drugsAnticoagulant drugs | Drug | Anticoagulated patients |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Halted Prematurely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Background: PubMed 23097696Testa 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.
- Background: PubMed 26001109Antonucci 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.
- Background: PubMed 24315724Ruff 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.
- Background: PubMed 22449293EINSTEIN-PE Investigators; Buller 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.
- Background: PubMed 19966341Schulman 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.
- Background: PubMed 23216615Agnelli 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.
- Background: PubMed 23991658Hokusai-VTE Investigators; Buller HR, Decousus 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.
- Background: PubMed 26037103Caldeira D, Rodrigues FB, Barra M, Santos AT, de Abreu D, Goncalves 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.
- Background: PubMed 15842354Schulman 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. doi: 10.1111/j.1538-7836.2005.01204.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Batel Marques, PhD principal investigator
AIBILI - Association for Innovation and Biomedical Research on Light and Image
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Venous Thromboembolism, run by CHAD at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Halted Prematurely). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complications (time frame: At least 12 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03977363, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.