Status:
COMPLETED
INdobufen Versus aSpirin in acUte Ischemic stRokE,INSURE
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Ischemic Stroke
Indobufen
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
China has the largest burden of cerebrovascular disease in the world. About 60% to 80% of which are ischemic stroke. In recent years, stroke has replaced heart disease and tumor diseases as the first ...
Detailed Description
China has the largest burden of cerebrovascular disease in the world. About 60% to 80% of which are ischemic stroke. In recent years, stroke has replaced heart disease and tumor diseases as the first ...
Eligibility Criteria
Inclusion
- Female or male aged≥18 years and\<80years.
- Acute moderate/severe ischemic stroke, 4≤NIHSS（National Institute of Health stroke scale）≤18 at the time of randomization.
- Patients can be randomized within 72 hours of symptoms onset.
- Provision of informed consent prior to any study specific procedures. \* Symptom onset is defined by the "last seen normal" principle
Exclusion
- Diagnosis of intracerebral hemorrhage such as cerebral hemorrhage, subarachnoid hemorrhage, etc.
- Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI.
- Moderate to severe ischemic stroke induced by angioplasty/vascular surgery.
- Modified Rankin Scale Score\>2 at randomization (pre-morbid historical assessment).
- History of aneurysm (including intracranial aneurysm or peripheral aneurysms).
- Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, atrial myxoma, prosthetic cardiac valves known or suspected endocarditis).
- History of Hemostatic disorder, systemic bleeding, thrombocytopenia or neutropenia.
- History of previous symptomatic non-traumatic intracerebral bleed or cerebral artery amyloidosis.
- Gastrointestinal (GI) bleed within the past 6 months before randomization.
- Major surgery within the past 3 months before randomization.
- Severe renal or hepatic insufficiency. (Severe hepatic insufficiency is defined as alanine aminotransferase (ALT) value\>3 times normal upper limit or Aspartate aminotransferase (AST)\>2 times normal upper limit; Severe renal insufficiency is defined as creatinine\>2 times normal upper limit).
- Diagnosis or of acute coronary syndrome.
- Other antithrombotic therapy are required during the study, including antiplatelet therapy(such as open-labeled aspirin, GPIIb/IIIa inhibitors, clopidogrel, ticagrelor, prasugrel, dipyridamole, ozagrel, cilostazol, etc.) and anticoagulant therapy(such as warfarin, thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, heparin and low molecular heparin, etc.).
- Within randomized 24 hours prior to any venous or arterial thrombolysis, mechanical bolt, snake venom, defibrase, lumbrokinase, etc.
- Heparin or oral anticoagulants were used within 10 days of randomization.
- Have a history of drug or food allergy and are known to be allergic to the study drug ingredients
- Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months (if clinically indicated, vascular imaging should be performed prior to randomization whenever possible)
- Anticipated requirement for long-term (\>7 days) non-steroidal antiinflammatory drugs (NSAIDs).
- The blood pressure needs to be controlled within the range of 90mmHg/60mmHg to 220mmHg/120mmHg.
- Suffering from serious cardiopulmonary disease, the researchers believe that it is not suitable for this study
- Patients with life expectancy\<3 months or patients who are unable to complete the study for other reasons.
- Women of childbearing age who are negative in pregnancy test but refuse to practice reliable contraception. Women who are pregnant or lactating.
- Involving in other investigational drug or device tests within the past 30 days before randomization.
- Inability of the patient to understand and/or comply with study procedures and/or follow-up due to mental illness, cognitive or emotional disorders
Key Trial Info
Start Date :
June 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
5438 Patients enrolled
Trial Details
Trial ID
NCT03871517
Start Date
June 3 2019
End Date
December 1 2022
Last Update
January 9 2023
Active Locations (1)
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1
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050