Status:
COMPLETED
Statin and Dual Antiplatelet Therapy to Prevent Early Neurological Deterioration in Branch Atheromatous Disease
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Acute Stroke
Dual Antiplatelet Therapy
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
Branch atheromatous disease (BAD) has been reported to contribute to small-vessel occlusion and is associated with a higher possibility of early neurological deterioration (END). Because the pathology...
Detailed Description
The SATBRAD study is a single-centre, prospective, open-label, single-group trial with a historical control group of BAD patients treated with single antiplatelet therapy and regular statin treatment ...
Eligibility Criteria
Inclusion
- Clinical diagnosis of ischemic stroke with National Institute of Health Stroke Scale (NIHSS) score of 1-8
- An ischemic lesion on diffuse-weighted imaging located in the MCA perforator, or Heubner's artery territories or vertebro-basilar perforator territories at brain stem.
- Branch atheromatous disease, defined by a visible lesion in three or more axial MRI cuts in the MCA perforator or Heubner's artery territories or infarcts that extended from the basal surface of the brainstem.
- Ability to randomize within 24 hours of time last known free of new ischemic symptoms.
- Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess, that could explain symptoms or contraindicate therapy.
- Ability to tolerate high intensity medical therapy, including aspirin at a dose of 50-325 mg/day, clopidogrel with 300mg loading and 75mg after day 2 and high-intensity statin(either atorvastatin 40-80mg or rosuvastatin 20 mg/day).
- Pre-stroke mRS≦1
Exclusion
- Age \< 20 years.
- In the judgment of the treating physician
- A candidate for thrombolysis, endarterectomy or endovascular intervention.
- Receipt of any intravenous or intra-arterial thrombolysis within 1 week prior to index event.
- Patients with more than 50% stenosis of the relevant arteries on magnetic resonance angiography (MRA), including intra- or extra-cranial internal carotid artery, middle cerebral artery or basilar artery.
- Patients with high risk of cardioembolic source, such as atrial fibrillation, acute myocardial infarction, severe heart failure or valvular heart disease.
- Other determined stroke etiology, such as vasculitis, shock, antiphospholipid antibody syndrome and etc.
- Gastrointestinal bleed or major surgery within 3 months prior to index event.
- History of nontraumatic intracranial hemorrhage.
- Clear indication for anticoagulation during the study period (deep venous thrombosis, pulmonary embolism or hypercoagulable state).
- Qualifying ischemic event induced by angiography or surgery.
- Severe non-cardiovascular comorbidity with life expectancy \<3 months.
- Contraindication to clopidogrel, aspirin, atorvastatin or rosuvastatin
- Known allergy to clopidogrel, aspirin atorvastatin or rosuvastatin
- Severe renal (serum creatinine \>2 mg/dL) or hepatic insufficiency (INR\>1.2; ALT\>40 U/L or any resultant complication, such as variceal bleeding, encephalopathy, or jaundice)
- Hemostatic disorder or systemic bleeding in the past 3 months
- Current thrombocytopenia (platelet count \<100 x109/L) or leukopenia (\<2 x109/L)
- History of drug-induced hematologic or hepatic abnormalities
- Anticipated requirement for long-term (\>7 day) non-study antiplatelet drugs (e.g., dipyridamole, ticagrelor, ticlopidine), or NSAIDs.
- Low-density lipoprotein\<70mg/dl without prior statin treatment in recent one year or within 2 days after recruitment
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT04824911
Start Date
March 23 2021
End Date
February 28 2025
Last Update
March 26 2025
Active Locations (1)
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1
Yenchu Huang
Chiayi City, Taiwan, 613