Statin and Dual Antiplatelet Therapy to Prevent Early Neurological Deterioration in Branch Atheromatous Disease

Phase 2

Recruiting

• Conditions: Acute Stroke; Dual Antiplatelet Therapy; Statin

• Registration Number: NCT04824911
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-3-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 424

Inclusion Criteria

Inclusion Criteria:<br><br> - Clinical diagnosis of ischemic stroke with National Institute of Health Stroke Scale<br> (NIHSS) score of 1-8<br><br> - An ischemic lesion on diffuse-weighted imaging located in the MCA perforator, or<br> Heubner's artery territories or vertebro-basilar perforator territories at brain<br> stem.<br><br> - Branch atheromatous disease, defined by a visible lesion in three or more axial MRI<br> cuts in the MCA perforator or Heubner's artery territories or infarcts that extended<br> from the basal surface of the brainstem.<br><br> - Ability to randomize within 24 hours of time last known free of new ischemic<br> symptoms.<br><br> - Head CT or MRI ruling out hemorrhage or other pathology, such as vascular<br> malformation, tumor, or abscess, that could explain symptoms or contraindicate<br> therapy.<br><br> - Ability to tolerate high intensity medical therapy, including aspirin at a dose of<br> 50-325 mg/day, clopidogrel with 300mg loading and 75mg after day 2 and<br> high-intensity statin(either atorvastatin 40-80mg or rosuvastatin 20 mg/day).<br><br> - Pre-stroke mRS?1<br><br>Exclusion Criteria:<br><br> - Age < 20 years.<br><br> - In the judgment of the treating physician<br><br> - A candidate for thrombolysis, endarterectomy or endovascular intervention.<br><br> - Receipt of any intravenous or intra-arterial thrombolysis within 1 week prior to<br> index event.<br><br> - Patients with more than 50% stenosis of the relevant arteries on magnetic resonance<br> angiography (MRA), including intra- or extra-cranial internal carotid artery, middle<br> cerebral artery or basilar artery.<br><br> - Patients with high risk of cardioembolic source, such as atrial fibrillation, acute<br> myocardial infarction, severe heart failure or valvular heart disease.<br><br> - Other determined stroke etiology, such as vasculitis, shock, antiphospholipid<br> antibody syndrome and etc.<br><br> - Gastrointestinal bleed or major surgery within 3 months prior to index event.<br><br> - History of nontraumatic intracranial hemorrhage.<br><br> - Clear indication for anticoagulation during the study period (deep venous<br> thrombosis, pulmonary embolism or hypercoagulable state).<br><br> - Qualifying ischemic event induced by angiography or surgery.<br><br> - Severe non-cardiovascular comorbidity with life expectancy <3 months.<br><br> - Contraindication to clopidogrel, aspirin, atorvastatin or rosuvastatin<br><br> - Known allergy to clopidogrel, aspirin atorvastatin or rosuvastatin<br><br> - Severe renal (serum creatinine >2 mg/dL) or hepatic insufficiency (INR>1.2; ALT>40<br> U/L or any resultant complication, such as variceal bleeding, encephalopathy, or<br> jaundice)<br><br> - Hemostatic disorder or systemic bleeding in the past 3 months<br><br> - Current thrombocytopenia (platelet count <100 x109/L) or leukopenia (<2 x109/L)<br><br> - History of drug-induced hematologic or hepatic abnormalities<br><br> - Anticipated requirement for long-term (>7 day) non-study antiplatelet drugs (e.g.,<br> dipyridamole, ticagrelor, ticlopidine), or NSAIDs.<br><br> - Low-density lipoprotein<70mg/dl without prior statin treatment in recent one year or<br> within 2 days after recruitment

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of patients with early neurological deterioration within 7 days and recurrent ischemic stroke within 30 days.

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with favorable functional recovery defined as a mRS ?1;Percentage of patients with new clinical vascular events;Changes of atherosclerotic plaque;Numbers of moderate to severe bleeding events;Total mortality