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

Congenital Heart Disease Clinical Trial

— PROTECT_AR  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03854149
• Other study ID #: PROTECT_AR_trial_01102018_v1.0
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: May 30, 2023

Study information

• Verified date: June 2023
• Source: AHEPA University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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)

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: May 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female patients aged =18 years.

2. Presence of congenital heart disease (intracardiac repair, cyanosis, Fontan palliation, or systemic right ventricle or other congenital heart disease).

3. Non-Valvular Atrial Arrhythmia (including at least one electrocardiographically documented episode).

4. 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:

1. moderate-to-severe mitral stenosis or mechanical valves

2. patient unwilling or unable to complete follow-up procedures

Related Conditions & MeSH terms

• Anticoagulants Causing Adverse Effects in Therapeutic Use
• Arrhythmias, Cardiac
• Atrial Arrhythmia
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Thromboembolism

Locations

Country	Name	City	State
Greece	Attikon University Hospital	Athens
Greece	Mitera Children's Hospital	Athens
Greece	Onassis Cardiac Surgery Centre	Athens
Greece	AHEPA University Hospital	Thessaloníki

Sponsors (4)

Lead Sponsor	Collaborator
AHEPA University Hospital	Attikon Hospital, MITERA Children's Hospital, Onassis Cardiac Surgery Centre

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	General quality of life	Assessed with questionnaire SF-36	Baseline
Other	Apixaban persistence	The proportion of patients who were on apixaban at enrolment and continued receiving apixaban at the end of the study period.	up to 58 months
Other	Apixaban adherence	Assessed by reviewing electronic pharmacy prescription data	up to 58 months
Primary	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
Primary	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	Transient ischemic attack	Defined as new neurologic symptoms or deficit lasting less than 24 hours with no new infarction on neuroimaging (if available).	up to 58 months
Secondary	Myocardial infarction	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]	up to 58 months
Secondary	Death from cardiovascular causes	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.	up to 58 months
Secondary	?he composite of major and clinically relevant nonmajor bleeding	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.	up to 58 months
Secondary	?he composite of stroke, systemic or pulmonary arterial thromboembolism and intracardiac thrombosis, transient ischemic attack, myocardial infarction, or cardiovascular death		up to 58 months

External Links

•   CHALLENGE Registry