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NCT Number: NCT05845372

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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Medical University Union Hospital, Fuzhou, Fujian, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 90-day mortality after onset

    Time frame: 90-day after onset

    Proportion of enrolled patients who died 90 days after onset of disease.

  2. 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

Secondary outcomes

  1. Incidence of clinically significant bleeding

    Time frame: within 7-day of onset

    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.

  2. Incidence of stress ulcer bleeding

    Time frame: 7-day after onset

    Coffee-like residue/black stool/blood in stool within 7-day after onset and more than 2 consecutive positive fecal/gastric fluid occult blood

  3. Incidence of unfavorable functional prognosis at 90 days after onset

    Time frame: 90-day after onset

    Incidence of unfavorable functional prognosis at 90 days after onset

  4. 90-day mRS score change

    Time frame: 90-day after onset

    Modified Rankin Scale score change within 90 days after onset in patients who were eligible for inclusion criteria

  5. Incidence of early neurological deterioration

    Time frame: within 72 hours after onset

    Increased score of National Institutes of Health Stroke Scale within 72h after onset ≥ 4

  6. 1-year post-onset mortality

    Time frame: 1 year after onset

    Mortality at 1 year after onset in patients who were eligible for inclusion criteria

  7. Incidence of adverse related events such as pneumonia or myocardial ischemia 1 year after onset

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Suyue Pan, M.D., Ph.D.

CONTACT

[email protected]

13556184981

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Dongguan People's Hospital
  • Fujian Medical University Union Hospital
  • Ganzhou City People's Hospital
  • Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Guangzhou Medical University
  • 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 Second Hospital University of South China
  • Yueyang People's Hospital

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 6, 2023
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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