Association of Prophylactic Use of Stress Ulcer Drugs and Clinical Outcomes in Patients With Acute Anterior Circulation Thrombectomy

Study Overview
=================
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.

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

Conditions
-----------------
Acute Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years. 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. Meet the indications for mechanical thrombectomy in the Chinese Guidelines for Early Endovascular Interventions in Acute Ischemic Stroke 2022. Treated with mechanical thrombectomy. NIHSS score ≥ 6 at onset of illness. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stress Ulcer Prophylaxis<br>Subjects are on stress ulcer medications including PPIs, H2RBs, and mucosal protectors at 24 h of admission. | |
| Control Group<br>Subjects are not on stress ulcer medications including PPIs, H2RBs, and mucosal protectors at 24 h of admission. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day mortality after onset | Proportion of enrolled patients who died 90 days after onset of disease. | 90-day after onset | 
| Incidence of stroke-associated pneumonia | Incidence of non-mechanically ventilated stroke patients with new pneumonia within 7-day of onset | within 7-day of onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of clinically significant bleeding | One of the following 4 symptoms occurs within 24 hours of bleeding from a stress ulcer (in the absence of other causes):1. A decrease of ≥ 20 mmHg in any one of systolic, diastolic and mean arterial pressure. 2.Initiation of blood pressure boosters or 20% increase in medication dose.3. Decreased hemoglobin ≥ 2 g/d(（1.24 mmol/l). 4.Infusion of erythrocytes ≥ 2 U. | within 7-day of onset | 
| Incidence of stress ulcer bleeding | Coffee-like residue/black stool/blood in stool within 7-day after onset and more than 2 consecutive positive fecal/gastric fluid occult blood | 7-day after onset | 
| Incidence of unfavorable functional prognosis at 90 days after onset | Incidence of unfavorable functional prognosis at 90 days after onset | 90-day after onset | 
| 90-day mRS score change | Modified Rankin Scale score change within 90 days after onset in patients who were eligible for inclusion criteria | 90-day after onset | 
| Incidence of early neurological deterioration | Increased score of National Institutes of Health Stroke Scale within 72h after onset ≥ 4 | within 72 hours after onset | 
| 1-year post-onset mortality | Mortality at 1 year after onset in patients who were eligible for inclusion criteria | 1 year after onset | 
| Incidence of adverse related events such as pneumonia or myocardial ischemia 1 year after onset | Incidence of adverse related events such as pneumonia or myocardial ischemia 1 year after onset in patients who were eligible for inclusion criteria | 1 year after onset | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Ischemic Stroke, Stress Ulcer Bleeding, Mechanical Thrombectomy