NCT04824911

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

Early Intensive Medical Therapy for the Prevention of Early Neurological Deterioration in Branch Atheromatous Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 376 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

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 in Chang Gung Memorial Hospital in Taiwan. Eligible participants are as follows: 1. have a clinical diagnosis of ischemic stroke; 2. National Institute of Health Stroke Scale (NIHSS) score of 1-8; 3. an ischemic lesion on diffuse-weighted imaging located in the middle cerebral artery(MCA) perforator, Heubner's artery or vertebrobasilar perforator territories; 4. BAD, defined by a visible lesion in three or more axial MRI cuts in the MCA perforator territory or Heubner's artery territories or infarcts that extended from the basal surface of the brainstem. 5. can receive intensive medical treatment within 24 hours of stroke onset. Participants in the intervention group will receive DAPT and high-intensity statin treatment. DAPT treatment is administered within 24 hours of stroke onset, with aspirin (300 mg loading and 100 mg/day) and clopidogrel (300mg and 75m/day). Participants will take aspirin and clopidogrel for 21 days and then keep aspirin or clopidogrel alone. High-intensity statin is administered, including atorvastatin 40-80mg or rosuvastatin 20 mg for 3 months. A historical control group of patients receiving single oral antiplatelet medication and regular statin treatment will be drawn from previous prospective observation studies which were executed since Jan. 2011 to Dec. 2020. The total sample sizes are 147 for intervention group and 277 for control group. The primary endpoint is the composite of END, defined as an increase of ≧2 points of NIHSS within 7 days, and recurrent ischemic stroke within 30 days.

Conditions

• Acute Stroke
• Dual Antiplatelet Therapy
• Statin

Interventions

Type	Name	Description
DRUG	Clopidogrel	300mg loading and 75mg/day from day 2
DRUG	Aspirin	Aspirin(100-300mg/day)
DRUG	Atorvastatin	Atorvastatin 40-80mg/day
DRUG	Rosuvastatin	Rosuvastatin 20 mg/day.

Timeline

• Start date: 2021-03-23
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2021-04-01
• Last updated: 2025-03-26

Locations

1 site across 1 country: Taiwan