drugset / Trial / NCT04824911

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

Phase 2 Completed 376 enrolled Chang Gung Memorial Hospital

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2021-03-23
Primary completion: 2025-02-28
Completion: 2025-02-28

Outcome

Met primary endpoint

paper The primary endpoint occurred less frequently in the intensive group (34.1% vs 48.1%; adjusted risk ratio (aRR), 0.71; 95% confidence interval (CI), 0.52-0.98; p = 0.034). PMID 40726739 ↗

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	100 mg	—
Subject	Aspirin	Small molecule	300 mg	—
Subject	Atorvastatin	Small molecule	40 mg	—
Subject	Atorvastatin	Small molecule	80 mg	—
Subject	Clopidogrel	Small molecule	75 mg	—
Subject	Rosuvastatin	Small molecule	20 mg	—