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

NCT03977363 | Terminated DMC

• 1 other identifier: CHAD-2019-01
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Venous Thromboembolism; Heart Valve Diseases or Prosthesis

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Anticoagulated patients

Patients receiving anticoagulation treatment

Drug: Anticoagulant drugs

Interventions

Anticoagulant drugs DRUG

Anticoagulant drugs

Anticoagulated patients

Eligibility Criteria

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

You may qualify if:

• Aged ≥18 years;
• Availability to sign an informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHAD: lead

Study Sites (1)

AIBILI - Association for Innovation and Biomedical Research on Light and Image

Coimbra, Portugal

Location

Related Publications (9)

• 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.

  PMID: 23097696 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 24315724 BACKGROUND

• 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.

  PMID: 22449293 BACKGROUND

• 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.

  PMID: 19966341 BACKGROUND

• 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.

  PMID: 23216615 BACKGROUND

• 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.

  PMID: 23991658 BACKGROUND

• 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.

  PMID: 26037103 BACKGROUND

• 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.

  PMID: 15842354 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Venous Thromboembolism; Heart Valve Diseases; Thromboembolism; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis

Interventions

Anticoagulants

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Francisco Batel Marques, PhD

  AIBILI - Association for Innovation and Biomedical Research on Light and Image

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Francisco Batel Marques

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 6, 2019
• Study Start: January 27, 2020
• Primary Completion: March 2, 2023
• Study Completion: March 2, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)