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

Acute Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05845372
• Other study ID #: NFEC-2023-040
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: April 2023
• Source: Nanfang Hospital of Southern Medical University
• Contact: Suyue Pan, M.D., Ph.D.
• Phone: 13556184981
• Email: pansuyue[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2592
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke

Locations

Country	Name	City	State
China	Sinopharm North Hospital	Baotou	Inner Mongolia
China	The First Hospital of Changsha	Changsha	Hunan
China	Dongguan donghua hospital	Dongguan	Guangdong
China	Dongguan People's Hospital	Dongguan	Guangdong
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Ganzhou City People's Hospital	Ganzhou	Jiangxi
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong
China	Huadu District People's Hospital of Guangzhou	Guangzhou	Guangdong
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The Fourth Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Haikou People's Hospital	Haikou	Hainan
China	Hainan Provincial People's Hospital	Haikou	Hainan
China	Hainan Traditional Chinese Medicine Hospital	Haikou	Hainan
China	The Second Hospital University of South China	Hengyang	Hunan
China	Heyuan people's Hospital	Heyuan	Guangdong
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia
China	Huizhou Municipal Central Hospital	Huizhou	Guangdong
China	Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Yueyang People's Hospital	Yueyang	Hunan

Sponsors (21)

Lead Sponsor

Collaborator

Nanfang Hospital of Southern Medical University

Dongguan donghua hospital, Dongguan People's Hospital, Fujian Medical University Union Hospital, Ganzhou City People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Haikou People's Hospital, Hainan People's Hospital, Hainan Traditional Chinese Medicine Hospital, Heyuan people's Hospital, Huadu District People's Hospital of Guangzhou, Huizhou Municipal Central Hospital, Kashgar 1st People's Hospital, Second Affiliated Hospital of Guangxi Medical University, Second Affiliated Hospital of Wenzhou Medical University, Sinopharm North Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, The Fourth Affiliated Hospital of Guangzhou Medical University, The Second Hospital University of South China, Yueyang People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-day mortality after onset	Proportion of enrolled patients who died 90 days after onset of disease.	90-day after onset
Primary	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	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
Secondary	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
Secondary	Incidence of unfavorable functional prognosis at 90 days after onset	Incidence of unfavorable functional prognosis at 90 days after onset	90-day after onset
Secondary	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
Secondary	Incidence of early neurological deterioration	Increased score of National Institutes of Health Stroke Scale within 72h after onset = 4	within 72 hours after onset
Secondary	1-year post-onset mortality	Mortality at 1 year after onset in patients who were eligible for inclusion criteria	1 year after onset
Secondary	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