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

• Status: Recruiting
• Trial end date: 2026-07-30
• Target enrollment: 0
• Participant gender: All

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 of BAD is due to atherosclerosis, the investigators postulate that early intensive medical treatment with dual antiplatelet therapy(DAPT) and high-intensity statin may prevent END and recurrent stroke. The investigators hypothesise that intensive medical therapy can prevent END in BAD using aspirin, clopidogrel and high-intensity statin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Treatments: Aspirin; Atorvastatin; Clopidogrel; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• 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, with an axial diameter ≦ 20mm.-.

• 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 Criteria:

• 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