Clinical trial NCT05845372: Association of Prophylactic Use of Stress Ulcer Drugs and Clinical Outcomes in Patients With Acute Anterior Circulation Thrombectomy
Official title: Association of Prophylactic Use of Stress Ulcer Drugs and Clinical Outcomes in Patients With Acute Anterior Circulation Thrombectomy: a Prospective, Multicenter, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Ischemic Stroke
Keywords: Acute Ischemic Stroke
Stress Ulcer Bleeding
Mechanical Thrombectomy
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Guangzhou Medical University
name: The Affiliated Hospital of Inner Mongolia Medical University
name: Second Affiliated Hospital of Wenzhou Medical University
name: Second Affiliated Hospital of Guangxi Medical University
name: Fujian Medical University Union Hospital
name: Huizhou Municipal Central Hospital
name: Haikou People's Hospital
name: Kashgar 1st People's Hospital
name: Ganzhou City People's Hospital
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Huadu District People's Hospital of Guangzhou
name: Dongguan donghua hospital
name: Sinopharm North Hospital
name: Heyuan people's Hospital
name: Hainan People's Hospital
name: Hainan Traditional Chinese Medicine Hospital
name: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
name: The Second Hospital University of South China
name: Dongguan People's Hospital
name: Yueyang People's Hospital
First posted: 2023-05-06
Enrollment: 2592
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: Patients who are treated with mechanical thrombectomy with acute anterior circulation large vessel occlusion. ≥18 years of age, within 24 hours of onset. Expected survival \>3 months. NIHSS score ≥ 6 at onset of illness.

Brief summary: Ischemic stroke accounts for a relatively high proportion of strokes. In recent years, intravenous thrombolysis and endovascular therapy have significantly improved the revascularization rate in patients with large vessel occlusive cerebral infarction, but 20-50% of patients still experience ineffective revascularization. Therefore, postoperative monitoring and treatment of patients with large vessel occlusions is crucial for early recognition, management and prevention of complications. Stress ulcer bleeding is a serious complication after acute ischemic stroke, with a prevalence of 1%-5%, and a previously proven incidence of stress ulcer bleeding after ischemic stroke. Stress ulcer bleeding after ischemic stroke has been shown to be closely associated with unfavorable outcomes, such as mortality. Current national and international guidelines or consensus on the prevention of stress ulcers after acute ischemic stroke do not advocate the routine use of histamine receptor antagonists or proton pump inhibitors for the prevention of stress ulcers, but rather should be considered in the context of the patient's risk factors for stress ulcers and discontinued after the patient initiates enteral nutrition. However, there is no evidence-based medical evidence to support the risk-benefit relationship of stress ulcer drug prophylaxis in patients with mechanical thrombectomy for acute anterior circulation large vessel occlusion.

Detailed description: Stress ulcer bleeding is a serious complication after acute ischemic stroke, with a prevalence of 1%-5%, of which only 0.5%-1% require blood transfusion or result in hypotension. Stress ulcer bleeding after ischemic stroke has been shown to be associated with poor outcomes, such as mortality, and basilar artery occlusion and middle cerebral artery cerebral infarction are independent risk factors for stress ulcer bleeding after acute ischemic stroke. Guidelines or consensus on the prevention of stress ulcers after acute ischemic stroke do not advocate the routine use of histamine receptor antagonists or proton pump inhibitors for stress ulcer prevention.

However, stress ulcer prophylaxis is initiated in most patients admitted to the neurological intensive care unit after mechanical embolization of acute anterior circulation large vessel occlusion. With advances such as diagnosis and early initiation of enteral nutrition, the rate of stress ulcer bleeding in patients with mechanical embolization of acute anterior circulation large vessel occlusion is significantly reduced. The relationship between the risk and benefit of SUP in patients undergoing mechanical embolization for acute anterior circulation large vessel occlusion is not yet supported by evidence-based medical evidence. Therefore, the purpose of this study was to investigate the correlation between pharmacological stress ulcer prophylaxis and clinical outcomes in patients undergoing mechanical thrombectomy for acute anterior circulation large vessel occlusion.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years.
2. Within 24 hours of onset. Meet the criteria for diagnosis of acute ischemic stroke in the "China Acute Ischemic Stroke Diagnosis and Treatment Guidelines 2018".
3. Meet the indications for mechanical thrombectomy in the "Chinese Guidelines for Early Endovascular Interventions in Acute Ischemic Stroke 2022".
4. Treated with mechanical thrombectomy.
5. NIHSS score ≥ 6 at onset of illness.
6. Sign an informed notice.

Exclusion Criteria:

Allergy to drug ingredients. Women who are pregnant or breastfeeding. Life expectancy of less than 3 months due to other non-ischemic stroke diseases such as malignancy, severe liver or renal failure.

Have participated in other interventional clinical studies (affecting the outcome of this cohort study).

Participants who were judged by the investigator to be unsuitable for participation in this study.

Primary outcomes:
measure: 90-day mortality after onset
timeFrame: 90-day after onset
measure: Incidence of stroke-associated pneumonia
timeFrame: within 7-day of onset
Secondary outcomes:
measure: Incidence of clinically significant bleeding
timeFrame: within 7-day of onset
measure: Incidence of stress ulcer bleeding
timeFrame: 7-day after onset
measure: Incidence of unfavorable functional prognosis at 90 days after onset
timeFrame: 90-day after onset
measure: 90-day mRS score change
timeFrame: 90-day after onset
measure: Incidence of early neurological deterioration
timeFrame: within 72 hours after onset
measure: 1-year post-onset mortality
timeFrame: 1 year after onset
measure: Incidence of adverse related events such as pneumonia or myocardial ischemia 1 year after onset
timeFrame: 1 year after onset
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Dongguan
country: China
facility: Dongguan donghua hospital
state: Guangdong
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Huadu District People's Hospital of Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Fourth Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Heyuan
country: China
facility: Heyuan people's Hospital
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
state: Guangdong
city: Haikou
country: China
facility: Haikou People's Hospital
state: Hainan
city: Haikou
country: China
facility: Hainan Provincial People's Hospital
state: Hainan
city: Haikou
country: China
facility: Hainan Traditional Chinese Medicine Hospital
state: Hainan
city: Changsha
country: China
facility: The First Hospital of Changsha
state: Hunan
city: Hengyang
country: China
facility: The Second Hospital University of South China
state: Hunan
city: Yueyang
country: China
facility: Yueyang People's Hospital
state: Hunan
city: Baotou
country: China
facility: Sinopharm North Hospital
state: Inner Mongolia
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Ganzhou
country: China
facility: Ganzhou City People's Hospital
state: Jiangxi
city: Wenzhou
country: China
facility: Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Department of Neurology, Nanfang Hospital,Southern Medical University
name: Suyue Pan
role: PRINCIPAL_INVESTIGATOR
References: