Clinical trial NCT05578300: Effective Translation of Endovascular Thrombectomy Trials Into Real-world Practice in the Asia-Pacific
Official title: Effective Translation of Endovascular Thrombectomy Trials Into Real-world Practice in the Asia-Pacific: a Multicenter, Prospective Registry (ENDURE-APAC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Stroke
Stroke, Acute
Stroke, Ischemic
Brain Diseases
Major Adverse Cardiovascular Event
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Linyi People's Hospital
First posted: 2022-10-13
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese Stroke Population

Brief summary: As a major breakthrough of acute stroke treatment over the past decade, endovascular thrombectomy (EVT) drastically improved neurological recovery and survival in patients with large vessel occlusion (LVO) ischemic strokes in major clinical trials. Nevertheless, much remained uncertain about the implementation of scientific evidence of EVT into real-world benefits. For instance, healthcare policies that influence critical time-matrices, endovascular thrombectomy techniques that may enhance success rate or prevent complications, or advanced imaging techniques that allow precise prognosis or expansion of treatment populations, should be evaluated. On the other hand, capturing LVO patients who were not able to undergo EVT may reveal the gap between clinical trials and real-world practice in the Asia-Pacific.

In this multicenter prospective collaboration across the Asian-Pacific, the investigators aim to evaluate the determinants of effective EVT in the real-world setting.

Detailed description: In this multicenter, prospective, longitudinal study, the investigators aim to evaluate the determinants of effective EVT in the real-world setting.

The investigators shall recruit patient who are over 18 years of age, with ischemic stroke with suspected large vessel occlusion (LVO), defined as occlusion of the internal carotid artery (ICA), M1 or M2 segment of the middle cerebral artery (MCA), or basilar artery (BA).

Detailed study procedures are as follows:

1. As the EVT center of the New Territory East Cluster (NTEC), all patients who undergo EVT triage in the NTEC, i.e. patients with suspected LVO, would be assessed by neuro-interventionists from the Prince of Wales Hospital (PWH). Eligibility screening for recruitment under the ENDURE-APAC registry will be carried out simultaneously.
2. The investigators shall obtain informed consent either from patient or next-of-kin. Informed consent will be obtained from his/her legal guardian or next-of-kin for those incompetent subjects who are willing to participate in the study. Subjects will be reconsented when competent.
3. After the informed consent, a study identity number will be assigned to each participant. The investigators shall obtain the following data:

   1. Demographic data such as age, gender, date of birth, smoking and drinking habit, pre-morbid functional status (by modified Rankin Scale (mRS)).
   2. Co-morbidities including hypertension, diabetes mellitus, hyperlipidemia, atrial fibrillation, previous strokes, ischemic heart disease, peripheral vascular disease, congestive heart failure, etc.
   3. Concurrent medications including anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban, heparin, warfarin), antiplatelet agents (aspirin, clopidogrel, ticagrelor, cilostazol), lipid-lowering agents (simvastatin, atorvastatin, rosuvastatin, pravastatin, fluvastatin, ezetimibe, gemfibrozil, fenofibrate, erenumab), antihypertensive (angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta blockers, calcium channel blockers, diuretics, aldosterone antagonists, nitrates, etc.), cytochrome P450 or P-glycoprotein inhibitors (amiodarone, dronedarone, phenytoin, valproate, carbamazepine, levetiracetam, rifampicin, cyclosporin, etc.), non-steroidal anti-inflammatory agents or cyclo-oxygenase2 inhibitors (indomethacin, ibuprofen, diclofenac, celecoxib, etorixocib), glucose lowering drugs (metformin, gliclazide, glimepiride, empagliflozin, dapagliflozin, insulin, exenatide, semaglutide, liraglutide, dulaglutide).
   4. Radiological findings, treatment outcomes and complications (see 2.3.2 and 2.3.4.) will be documented.
   5. Baseline hemoglobin, white blood cell, platelet count, creatinine, sodium, potassium, alanine transferase, alkaline phosphatase, high density lipoprotein cholesterol, low density lipoprotein cholesterol, total cholesterol, triglyceride level, prothrombin time, activated thromboplastin time, fasting glucose, glycated hemoglobin A1c will be documented.

Eligibility criteria: Inclusion Criteria:

* Patient who are over 18 years of age.
* Patient with ischemic stroke with suspected large vessel occlusion (LVO), defined as occlusion of the internal carotid artery (ICA), M1 or M2 segment of the middle cerebral artery (MCA), or basilar artery (BA).

Exclusion Criteria:

* Patient with isolated vertebral artery occlusion not involving the BA.

Primary outcomes:
measure: Pre-morbid functional status assessed by modified Rankin Scale (mRS)
timeFrame: 18 October 2032
Secondary outcomes:
Other outcomes:
Locations:
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Medical College of Qingdao University
state: Shandong
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Bonaventure Yiu Ming IP, MB ChB
role: PRINCIPAL_INVESTIGATOR
References: