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Completed

NCT Number: NCT03854149

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

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)

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Key information

Conditions

Congenital Heart Disease Anticoagulants Causing Adverse Effects in Therapeutic Use Arrhythmias, Cardiac Atrial Arrhythmia Atrial Fibrillation Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Embolism and Thrombosis Heart Defects, Congenital Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Attikon University Hospital, Athens, Greece

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About this study

Adult patients with congenital heart disease (ACHD) represent a rapidly growing population due to the progress of surgical techniques and optimal medical management. Non-valvular atrial arrhythmias (AA) carries a significant burden for long-term morbidity and potentially mortality in ACHD patients. AA occur three times more frequently in ACHD compared to the general population. When complicating ACHD, AA convey a twofold increase in the risk for stroke, contributing to an up to 100-fold higher prevalence of stroke in the ACHD population compared to age-matched healthy controls. At present, the European Society of Cardiology (ESC) Guidelines suggest oral anticoagulation (OAC) in all adult patients with AA and intracardiac repair, cyanosis, Fontan palliation, or systemic right ventricle. In the remaining ACHD patients with AA, OAC is suggested if CHA2DS2-Vasc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke/transient ischemic attack, vascular disease, age 65 to 74 years, sex category) score is ≥1 (Class of recommendation IIa, level of evidence C).

Non-vitamin K oral anticoagulants (NOACs) are increasingly preferred over vitamin-K antagonists (VKAs) in most clinical scenarios due to improved safety (with regard to intracranial and other major bleeding) and efficacy (prevention of embolic stroke or systemic embolism) along with the convenience they offer for patients and physicians (fixed dose, no food and drug interactions, no INR monitoring). On the other hand, scarce data is available on the use of NOAC in ACHD.

In order to address this gap in evidence, we propose a prospective multicenter single arm, observational cohort trial, which will provide data on the efficacy and safety of apixaban used for the prevention of thromboembolism in ACHD patients with AA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: up to 58 months

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

  2. Major bleeding

    Time frame: up to 58 months

    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)

Secondary outcomes

  1. Transient ischemic attack

    Time frame: up to 58 months

    Defined as new neurologic symptoms or deficit lasting less than 24 hours with no new infarction on neuroimaging (if available).

  2. Myocardial infarction

    Time frame: up to 58 months

    Defined as the detection of a significant rise/fall of Troponin in association with symptoms of ischemia, ECG changes, proof of ischemia on imaging or intracoronary thrombus at angiography. [Fourth definition of myocardial infarction; European Society of Cardiology (ESC) 2018]

  3. Death from cardiovascular causes

    Time frame: up to 58 months

    Cardiovascular deaths were classified as deaths due to: ischemic stroke, hemorrhagic stroke, systemic or pulmonary embolism, other cardiovascular (i.e., myocardial infarction, sudden death, heart failure) and unobserved deaths.

  4. Τhe composite of major and clinically relevant nonmajor bleeding

    Time frame: up to 58 months

    Clinically relevant nonmajor bleeding bleeding=bleeding that is clinically overt, that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event, that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.

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

    Time frame: up to 58 months

Other outcomes

  1. General quality of life

    Time frame: Baseline

    Assessed with questionnaire SF-36

  2. Apixaban persistence

    Time frame: up to 58 months

    The proportion of patients who were on apixaban at enrolment and continued receiving apixaban at the end of the study period.

  3. Apixaban adherence

    Time frame: up to 58 months

    Assessed by reviewing electronic pharmacy prescription data

Sponsors and collaborators

Lead sponsor

AHEPA University Hospital

Other

Collaborators

  • Attikon Hospital
  • MITERA Children's Hospital
  • Onassis Cardiac Surgery Centre

Registry information

Official study title

A Prospective, Observational, Multicenter 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

Acronym: PROTECT_AR

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 26, 2019
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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