Status:
ENROLLING_BY_INVITATION
Antithrombotic Therapy With Regulation of Blood Pressure in Non-Cardioembolic Progressive Stroke
Lead Sponsor:
Ruijin Hospital
Conditions:
Stroke, Ischemic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Stroke has become the leading cause of death in China, with acute ischemic stroke still progressing within one week of onset, known as progressive ischemic stroke (PIS), which has a high rate of disab...
Detailed Description
This is a single-center randomized controlled study conducted to explore the efficacy and safety of antithrombotic therapy with regulation of blood pressure in non-cardioembolic PIS. We plan to recru...
Eligibility Criteria
Inclusion
- Adults (aged ≥18 years) with an AIS who have been able to complete usual activities in daily life without support before the stroke;
- One of the following PIS manifestations:
- Within 7 days of onset, when symptom worsens and there are new lesions or infarct growth on DWI within 24 hours of aggravation, the National Institutes of Health Stroke Scale (NIHSS) score increases by ≥ 2 points ;
- Within 24 hours after IVT, when symptom worsens and there are new lesions or infarct growth on DWI within 24 hours of aggravation, the NIHSS score increases by ≥ 4 points compared to the baseline;
- Within 3h of stroke progression, ≥2 successive measurements of systolic blood pressure (SBP) \< 160 mm Hg for \>10 min.
- Computed tomographic angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA) confirms patients without visible large or medium-sized intracranial vessel occlusion.
Exclusion
- After stroke progression, a head CT confirmed new cerebral hemorrhage or hemorrhagic transformation.
- Endovascualr treatment had been performed before stroke progression (thrombectomy, stent placement, balloon dilatation) or if surgery or interventional treatment had been scheduled;
- Current treatment with heparin therapy or oral anticoagulation (presumed cardiac source of embolus, such as atrial fibrillation, prosthetic cardiac valve, and known or suspected endocarditis);
- Previous diseases of the brain that include intracranial hemorrhage or amyloid angiopathy; brain surgery or hemorrhagic stroke; stroke within the last three months;
- Preexisting serious diseases: Cancer, AIDS, serious heart disease, dementia, liver diseases such as liver failure, cirrhosis, portal hypertension and active hepatitis, acute or chronic severe renal impairment (glomerular filtration rate \< 30 ml/min/1·73 m2 );
- Contraindication to aspirin or clopidogrel;
- Pregnant and lactating women.
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06551727
Start Date
August 15 2024
End Date
July 31 2025
Last Update
October 16 2024
Active Locations (1)
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1
Ruijin North Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 201800