Apixaban in Adults With Congenital Heart Disease and Atrial Arrhythmias: the PROTECT-AR Study

NCT03854149 | Completed DMC

• 1 other identifier: PROTECT_AR_trial_01102018_v1.0
• Study Type: observational
• Target: 218
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of apixaban for the prevention of thromboembolism in adult patients with congenital heart disease (CHD) and non-valvular atrial arrhythmias (AA)

Conditions

Congenital Heart Disease; Atrial Arrhythmia; Thromboembolism; Anticoagulants Causing Adverse Effects in Therapeutic Use

Keywords

Congenital Heart Disease; Atrial Fibrillation; Thromboembolism; NOAC; Apixaban; Atrial arrhythmias

Outcome Measures

Primary Outcomes (2)

• Stroke, systemic or pulmonary arterial thromboembolism and intracardiac thrombosis.

  The composite endpoint of all-cause stroke, systemic and pulmonary embolism and intracardiac thrombosis

  up to 58 months

• Major bleeding

  Defined as clinically overt bleeding that is associated with: * A fall in hemoglobin of 2 g/dL or more * A transfusion of ≥2 units of packed red blood cells or whole blood * Bleeding in a critical site: intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal * Death (fatal bleeding)

  up to 58 months

Secondary Outcomes (5)

• Transient ischemic attack

  up to 58 months

• Myocardial infarction

  up to 58 months

• Death from cardiovascular causes

  up to 58 months

• Τhe composite of major and clinically relevant nonmajor bleeding

  up to 58 months

• Τhe composite of stroke, systemic or pulmonary arterial thromboembolism and intracardiac thrombosis, transient ischemic attack, myocardial infarction, or cardiovascular death

  up to 58 months

Other Outcomes (3)

• General quality of life

  Baseline

• Apixaban persistence

  up to 58 months

• Apixaban adherence

  up to 58 months

Study Arms (1)

Adults with CHD & non-valvular atrial arrhythmias

Adults with congenital heart disease and non-valvular atrial arrhythmias (atrial fibrillation, atrial flutter or intra-atrial re-entrant tachycardia)

Eligibility Criteria

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

Study Population

Adult patients with Congenital Heart Disease and Non-Valvular Atrial Arrhythmias who are routinely treated with apixaban (i.e., new or ongoing users) for stroke prevention at any health-care level in Greece

You may qualify if:

• Male or female patients aged ≥18 years.
• Presence of congenital heart disease (intracardiac repair, cyanosis, Fontan palliation, or systemic right ventricle or other congenital heart disease).
• Non-Valvular Atrial Arrhythmia (including at least one electrocardiographically documented episode).
• Signed written informed consent by the patient for participation in the study and agreement to comply with the medication and the follow-up schedule.

You may not qualify if:

• moderate-to-severe mitral stenosis or mechanical valves
• patient unwilling or unable to complete follow-up procedures

Sponsors & Collaborators

• AHEPA University Hospital: lead
• Onassis Cardiac Surgery Centre: collaborator
• Attikon Hospital: collaborator
• MITERA Children's Hospital: collaborator

Study Sites (4)

Attikon University Hospital

Athens, 12462, Greece

Location

Mitera Children's Hospital

Athens, 15123, Greece

Location

Onassis Cardiac Surgery Centre

Athens, 17674, Greece

Location

AHEPA University Hospital

Thessaloniki, 54636, Greece

Location

Related Publications (1)

• Kartas A, Doundoulakis I, Ntiloudi D, Koutsakis A, Kosmidis D, Rampidis G, Apostolopoulou S, Frogoudaki A, Tzifa A, Avramidis D, Ntzoyvara O, Liori S, Mousiama T, Mouratoglou SA, Karvounis H, Giannakoulas G. Rationale and design of a prospective, observational, multicentre study on the safety and efficacy of apixaban for the prevention of thromboembolism in adults with congenital heart disease and atrial arrhythmias: the PROTECT-AR study. BMJ Open. 2020 Sep 22;10(9):e038012. doi: 10.1136/bmjopen-2020-038012.

  PMID: 32963069 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Thromboembolism; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Embolism and Thrombosis; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Georgios Giannakoulas, MD, PhD

  AHEPA University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - MD, PhD

Study Record Dates

• First Submitted: February 23, 2019
• First Posted: February 26, 2019
• Study Start: July 1, 2019
• Primary Completion: April 30, 2023
• Study Completion: May 30, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

GR (4)