NCT03977363|TerminatedDMC
Study Stopped
Halted Prematurely
The Portuguese Survey on Anticoagulated Patients Register (START-Portugal-Register)
START-Portugal
Loading search results
Sponsor study identifier
observational
25
1 country
1
Study Start
January 27, 2020
Actual (reported)Primary Completion
March 2, 2023
Actual (reported)Study Completion
March 2, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 5, 2019
Actual (reported)June 6, 2019
Actual (reported)January 27, 2020
Actual (reported)March 2, 2023
Actual (reported)March 2, 2023
Actual (reported)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.
At least 12 months of follow-up
Patients receiving anticoagulation treatment
Anticoagulant drugs
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
AIBILI - Association for Innovation and Biomedical Research on Light and Image
Coimbra, Portugal
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.
Francisco Batel Marques, PhD
AIBILI - Association for Innovation and Biomedical Research on Light and Image
25 participants (actual enrollment reported by the registry).
First Submitted
June 5, 2019
First Posted
June 6, 2019
Study Start
January 27, 2020
Actual (reported)Edoxaban Management in Diagnostic and Therapeutic Procedures
Contact the study team to confirm eligibility.
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; 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.
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; 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.
Caldeira 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.
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. doi: 10.1111/j.1538-7836.2005.01204.x.
Primary Completion
March 2, 2023
Actual (reported)Study Completion
March 2, 2023
Actual (reported)Last Updated
May 17, 2023
Record last verified: 2023-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: