Clinical Survey on the Stroke Prevention in Atrial Fibrillation in Asia

NCT04807049 | Completed DMC

• 1 other identifier: Version 1.1
• Study Type: observational
• Target: 4,504
• Locations: 2 countries
• Sites: 2

Brief Summary

Despite relatively lower prevalence of atrial fibrillation (AF) in Asians (\~1%) than Caucasians (\~2%) as reported in observational studies, Asia has a much higher overall disease burden, due to its proportionally larger aged population. Based on reported prevalence rates and projected population figures in Asia, there will be an estimated 49 million men and 23 million women with AF, by year 2050. Stroke is a disabling complication of AF that is of particular cause for concern in Asians patients. Implementing consensus expert recommendations for managing stroke risk in AF patients can considerably reduce stroke rates. However, caution is necessary when aligning management of Asian AF patients to that of their Caucasian counterparts. Current international guidelines and risk stratification tools for AF management are based on findings in predominantly Caucasian populations and may therefore have limited relevance, in certain respects, to Asian patients. The vitamin K antagonist (VKA), warfarin and alternative new oral anticoagulants, direct thrombin inhibitors or factor Xa inhibitors is recommended for reducing the risk of stroke and thromboembolism in high-risk patients with non-valvular AF. However, there is very limited information about the safety and efficacy of those agents in Asian population. Therefore, further research is urgently needed to inform specific guidance on the implications of different stroke and bleeding profiles in Asians versus Caucasians. In order to allow comparison between Asians versus Caucasians population, we propose to adopt the current study protocol and case report form of the EurObservational Research Programme on Atrial Fibrillation General Long-Term study.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Stroke Prevention in Atrial Fibrillation in Asia

  To verify the applicability, and to adapt or strengthen international practice guidelines (recommendations) on the diagnosis and treatment of AF and facilitate implementation of such guidelines. To investigate the applicability of the results of clinical trials in everyday practice. To analyse the outcome of different disease management strategies. To foster the implementation of evidence-based medicine.

  1 year

Interventions

Observational OTHER

Observational

Eligibility Criteria

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

Study Population

We propose to recruit 5,000 patients (\~1000 patients per country) from 5 countries in Asia-Pacific regions (Hong Kong, Japan, Taiwan, Singapore, Korea). Patients who are currently follow-up or newly diagnosed AF in these countries will be enrolled and follow-up for 1 year.

You may qualify if:

• Patients will be officially enrolled in the study only if ECG diagnosis of AF has been made.
• The qualifying episode of AF should have occurred within one year before the date of baseline.
• AF is the primary or secondary diagnosis, i.e. the current admission / visit may be due to other reasons.
• Patients need not be in AF at the time of enrolment.
• Signed Patient Inform Consent if applicable

You may not qualify if:

• No ECG/Holter with AF recorded.
• Only atrial flutter recorded.
• The qualifying episode of AF occurred more than one year before the date of baseline.
• Age \<18 years.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Asia Pacific Heart Rhythm Society (APHRS): collaborator

Study Sites (2)

Queen Mary Hospital

Hong Kong, China

Location

National Heart Centre Singapore

Singapore, Singapore

Location

Related Publications (3)

• Bucci T, Romiti GF, Shantsila A, Teo WS, Park HW, Shimizu W, Corica B, Proietti M, Tse HF, Chao TF, Frost F, Lip GYH; Asia-Pacific Heart Rhythm Society Atrial Fibrillation Registry Investigators. Risk of Death and Cardiovascular Events in Asian Patients With Atrial Fibrillation and Chronic Obstructive Pulmonary Disease: A Report From the Prospective APHRS Registry. J Am Heart Assoc. 2024 Apr 2;13(7):e032785. doi: 10.1161/JAHA.123.032785. Epub 2024 Mar 27.

  PMID: 38533983 DERIVED

• Bucci T, Shantsila A, Romiti GF, Teo WS, Chao TF, Shimizu W, Boriani G, Tse HF, Krittayaphong R, Lip GYH. External Validation of COOL-AF Scores in the Asian Pacific Heart Rhythm Society Atrial Fibrillation Registry. JACC Asia. 2023 Nov 14;4(1):59-69. doi: 10.1016/j.jacasi.2023.09.011. eCollection 2024 Jan.

  PMID: 38222252 DERIVED

• Bucci T, Proietti M, Shantsila A, Romiti GF, Teo WS, Park HW, Shimizu W, Tse HF, Lip GYH, Chao TF; APHRS-AF Registry Investigators. Integrated Care for Atrial Fibrillation Using the ABC Pathway in the Prospective APHRS-AF Registry. JACC Asia. 2023 Jun 27;3(4):580-591. doi: 10.1016/j.jacasi.2023.04.008. eCollection 2023 Aug.

  PMID: 37614548 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 19, 2021
• Study Start: April 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: March 1, 2021
• Last Updated: March 19, 2021

Record last verified: 2021-03

Locations

SG (1); CN (1)