Ischemic Strokes While on NOAC - How Compliance Matters

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT04607070

Collaborator

(none)

870

Enrollment

Location

Anticipated Duration (Months)

20.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is aimed to depict the epidemiological trend, aetiologies, clinical characteristics, treatment options of IS-NOAC in face of the rapidly increasing NOAC usage. Knowledge on this ischaemic stroke entity will define clinical characteristics, identify preventable causes and inform resource allocation on the evaluation modalities, reperfusion strategies and forecast future burden of IS-NOAC.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Ischemic Stroke, Acute Stroke Syndrome Stroke, Cardiovascular Atherosclerosis Ischemic Stroke

Detailed Description

Data will be retrieved from the stroke registry of Prince of Wales Hospital which recorded all in- and out-patients with stroke or transient ischaemic attack (TIA). All consecutive adult patients with known AF who developed ischaemic stroke or TIA in 2010, 2012, 2014, 2016 and 2018 (i.e. 5 full yearly time-points) and categorize the patients according to their anticoagulation status (elaborated below) with the inclusion and exclusion criteria stated will be recruited.

All demographic data, blood results, imaging and assessment data will be retrieved from electronic patient record (CMS system) and stroke registry. All-cause mortality at 1 year will be verified via CMS system too.

Study Design

Study Type:

Observational

Anticipated Enrollment :

870 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Ischemic Strokes While on NOAC - How Compliance Matters

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Stroke patient This is a registry-based study that will involve consecutive adult patients with known AF who developed ischaemic stroke or TIA in years 2010, 2012, 2014, 2016 and 2018.

Outcome Measures

Primary Outcome Measures

Compliance affects the outcomes of ischemic stroke during NOAC usage. [30 Sept 2021]
To depict epidemiological trend and aetiologies on different dosage of NOAC in stroke patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who were ethnic Chinese
Patients with known AF
Patient who suffered from ischaemic stroke

Exclusion Criteria:

Patient who are non-ethnic Chinese
Patient who suffered from haemorrhagic stroke

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chinese University of Hong Kong	Hong Kong		Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator: Yiu Ming Bonaventure IP, MBChB, MRCP, Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. IP Yiu Ming Bonaventure, Specialist resident, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT04607070

Other Study ID Numbers:

Crec 2020.427

First Posted:

Oct 28, 2020

Last Update Posted:

Aug 8, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. IP Yiu Ming Bonaventure, Specialist resident, Chinese University of Hong Kong

stroke, NOAC

Additional relevant MeSH terms:

Myocardial Infarction

Ischemia

Study Results

No Results Posted as of Aug 8, 2022