Association of Prophylactic Use of Stress Ulcer Drugs and Clinical Outcomes in Patients With Acute Anterior Circulation Thrombectomy
1 other identifier
observational
2,592
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
May 6, 2023
April 1, 2023
3.7 years
April 26, 2023
April 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
Incidence of clinically significant bleeding
within 7-day of onset
Incidence of stress ulcer bleeding
7-day after onset
Incidence of unfavorable functional prognosis at 90 days after onset
90-day after onset
90-day mRS score change
90-day after onset
Incidence of early neurological deterioration
within 72 hours after onset
- +2 more secondary outcomes
Study Arms (2)
Stress Ulcer Prophylaxis
Subjects are on stress ulcer medications including PPIs, H2RBs, and mucosal protectors at 24 h of admission.
Control Group
Subjects are not on stress ulcer medications including PPIs, H2RBs, and mucosal protectors at 24 h of admission.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- Guangzhou Medical Universitycollaborator
- The Affiliated Hospital of Inner Mongolia Medical Universitycollaborator
- Second Affiliated Hospital of Wenzhou Medical Universitycollaborator
- Second Affiliated Hospital of Guangxi Medical Universitycollaborator
- Fujian Medical University Union Hospitalcollaborator
- Huizhou Municipal Central Hospitalcollaborator
- Haikou People's Hospitalcollaborator
- Kashgar 1st People's Hospitalcollaborator
- Ganzhou City People's Hospitalcollaborator
- Guangdong Provincial Hospital of Traditional Chinese Medicinecollaborator
- Huadu District People's Hospital of Guangzhoucollaborator
- Dongguan donghua hospitalcollaborator
- Sinopharm North Hospitalcollaborator
- Heyuan people's Hospitalcollaborator
- Hainan People's Hospitalcollaborator
- Hainan Traditional Chinese Medicine Hospitalcollaborator
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicinecollaborator
- The Second Hospital University of South Chinacollaborator
- Dongguan People's Hospitalcollaborator
- Yueyang People's Hospitalcollaborator
Study Sites (19)
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Dongguan donghua hospital
Dongguan, Guangdong, China
Dongguan People's Hospital
Dongguan, Guangdong, 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
Heyuan people's Hospital
Heyuan, Guangdong, China
Huizhou Municipal Central Hospital
Huizhou, 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 First Hospital of Changsha
Changsha, Hunan, China
The Second Hospital University of South China
Hengyang, Hunan, China
Yueyang People's Hospital
Yueyang, Hunan, China
Sinopharm North Hospital
Baotou, Inner Mongolia, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Ganzhou City People's Hospital
Ganzhou, Jiangxi, China
Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suyue Pan
Department of Neurology, Nanfang Hospital,Southern Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2023
First Posted
May 6, 2023
Study Start
May 1, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
May 6, 2023
Record last verified: 2023-04