Acute Ischemic StrokeNCT05845372
Association of Prophylactic Use of Stress Ulcer Drugs and Clinical Outcomes in Patients With Acute Anterior Circulation Thrombectomy
An observational study of Acute Ischemic Stroke, run by Nanfang Hospital, Southern Medical University at 19 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 2,592 participants
- Where
- 19 sitesChina
- Study dates
- 1 May 2023to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
China19 sites, 19 recruiting
- Recruiting
Sinopharm North Hospital
Baotou, Inner Mongolia
Lifei Xing, M.D, 15354919958
- Recruiting
The First Hospital of Changsha
Changsha, Hunan
Xu Peng, M.D。, 15802507292
- Recruiting
Dongguan donghua hospital
Dongguan, Guangdong
Lingyu Sun, 13829203368
- Recruiting
Dongguan People's Hospital
Dongguan, Guangdong
Zhu Shi, M.D., 13669825459
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Shenggen Chen, M.D., 13459480275
- Recruiting
Ganzhou City People's Hospital
Ganzhou, Jiangxi
Zhaohui Lai, 13879729792
- Recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong
Lixin Wang, M.D., 13922793886
- Recruiting
Huadu District People's Hospital of Guangzhou
Guangzhou, Guangdong
Guangning Li, M.D., 13926239656
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong
Suyue Pan, 13556184981
- Recruiting
The Fourth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Wangchi Luo, M.D., 13710895142
- Recruiting
Haikou People's Hospital
Haikou, Hainan
Guoshuai Yang, M.D., 13876006248
- Recruiting
Hainan Provincial People's Hospital
Haikou, Hainan
Fan Zhang, M.D., 17389897580
- Recruiting
Hainan Traditional Chinese Medicine Hospital
Haikou, Hainan
Yong Gu, M.D., 15521280288
- Recruiting
The Second Hospital University of South China
Hengyang, Hunan
Yanhong Hu, M.D., 13265004191
- Recruiting
Heyuan people's Hospital
Heyuan, Guangdong
Minzhen Zhu, 15007622318
- Recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia
Lihua Sun, M.D., 18686292585
- Recruiting
Huizhou Municipal Central Hospital
Huizhou, Guangdong
Lizhi Wang, M.D., 13802872076
- Recruiting
Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Saijun Zhou, M.D., 13857746659
- Recruiting
Yueyang People's Hospital
Yueyang, Hunan
Yuan Zhou, M.D., 15107309796
About this study
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
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Stress Ulcer Bleeding, Mechanical Thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day mortality after onset
Proportion of enrolled patients who died 90 days after onset of disease.
Measured: 90-day after onset
Incidence of stroke-associated pneumonia
Incidence of non-mechanically ventilated stroke patients with new pneumonia within 7-day of onset
Measured: within 7-day of onset
Secondary outcomes (7)
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.
Measured: 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
Measured: 7-day after onset
Incidence of unfavorable functional prognosis at 90 days after onset
Incidence of unfavorable functional prognosis at 90 days after onset
Measured: 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
Measured: 90-day after onset
Incidence of early neurological deterioration
Increased score of National Institutes of Health Stroke Scale within 72h after onset ≥ 4
Measured: within 72 hours after onset
1-year post-onset mortality
Mortality at 1 year after onset in patients who were eligible for inclusion criteria
Measured: 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
Measured: 1 year after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 May 2023
- Primary completion1 Aug 2026
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,592 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Medical University, The Affiliated Hospital of Inner Mongolia Medical University, Second Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Guangxi Medical University, Fujian Medical University Union Hospital, Huizhou Municipal Central Hospital, Haikou People's Hospital, Kashgar 1st People's Hospital, Ganzhou City People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Huadu District People's Hospital of Guangzhou, Dongguan People's Hospital, Sinopharm North Hospital, Heyuan Shenhe People's Hospital, Hainan People's Hospital, Hainan Traditional Chinese Medicine Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, The Second Hospital University of South China, Yueyang People's Hospital
- Responsible party
- Sponsor
- Investigators
- Suyue Pan, Principal investigator, Department of Neurology, Nanfang Hospital,Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845372
- Sponsor's protocol ID
- NFEC-2023-040
- Status last verified
- Nov 2026
- First submitted
- 26 Apr 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05845372
- Acronym / sponsor ID
- NFEC-2023-040
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Stress Ulcer Bleeding, Mechanical Thrombectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,592 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Guangzhou Medical University, The Affiliated Hospital of Inner Mongolia Medical University, Second Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Guangxi Medical University, Fujian Medical University Union Hospital, Huizhou Municipal Central Hospital, Haikou People's Hospital, Kashgar 1st People's Hospital, Ganzhou City People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Huadu District People's Hospital of Guangzhou, Dongguan People's Hospital, Sinopharm North Hospital, Heyuan Shenhe People's Hospital, Hainan People's Hospital, Hainan Traditional Chinese Medicine Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, The Second Hospital University of South China, Yueyang People's Hospital
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
90-day mortality after onset
Time frame: 90-day after onset
Proportion of enrolled patients who died 90 days after onset of disease.
Incidence of stroke-associated pneumonia
Time frame: within 7-day of onset
Incidence of non-mechanically ventilated stroke patients with new pneumonia within 7-day of onset
7 secondary outcomes
Incidence of clinically significant bleeding
Time frame: within 7-day of onset
Incidence of stress ulcer bleeding
Time frame: 7-day after onset
Incidence of unfavorable functional prognosis at 90 days after onset
Time frame: 90-day after onset
90-day mRS score change
Time frame: 90-day after onset
Incidence of early neurological deterioration
Time frame: within 72 hours after onset
1-year post-onset mortality
Time frame: 1 year after onset
Incidence of adverse related events such as pneumonia or myocardial ischemia 1 year after onset
Time frame: 1 year after onset
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suyue Pan principal investigator
Department of Neurology, Nanfang Hospital,Southern Medical University
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Nanfang Hospital, Southern Medical University at 19 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suyue Pan, M.D., Ph.D. (13556184981, pansuyue@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day mortality after onset (time frame: 90-day after onset). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.