NCT05310968

Study on Tirofiban With Aspirin in the Treatment of Acute Penetrating Artery Territory Infarction

Study on Tirofiban With Aspirin in the Treatment of Acute Penetrating Artery Territory Infarction (STRATEGY)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 970 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Perforating artery territorial infarction (PAI) refers to a single ischemic lesion in a single perforating arterial territory and branch atheromatous disease (BAD) is an important type. BAD related stroke accounts for 10%-15% ischemic cerebral infarction and is closely related to early neurological deterioration (END). Among patients with single ischemic lesion in other study, dual antiplatelet (clopidogrel plus aspirin) did not significantly reduce the risk of recurrent stroke. The primary purpose of this study is to assess the efficacy and safety of tirofiban combined with aspirin versus placebo combined with aspirin in reducing the risk of stroke and END in patients with BAD.

Detailed description

Branch atheromatous disease (BAD) was characterized by cerebral infarction within penetrating artery territories. It arises from atherosclerotic stenosis or occlusion at the origin or proximal segment of these arteries, with three principal pathological manifestations. BAD is the typical etiology of the isolated infarction in penetrating artery territories. There is still no consensus on the classification, and both the TOAST and the CISS (Chinese ischemic stroke subclassification) have the limitations. Currently, there are no evidence-supported, guideline-based on how to prevent the END of BAD. Combining the pathology of atherosclerosis, we hypothesize that short-term use of tirofiban with aspirin for intensive antiplatelet therapy may confer benefits. The primary purpose of this study is to assess the efficacy and safety of tirofiban combined with aspirin versus placebo combined with aspirin in reducing END and stroke at 90 days in patients with BAD. This is a prospective, randomized, multicenter, double-blind clinical trial. In China, 970 patients with the following criteria will be enrolled: single acute infarction of penetrating artery territory (maximum diameter \<30 mm on DWI of MRI) within 48 hours, which involves two or more transverse layers, or whose maximum diameter ≥15 mm, , or connected to the ventral surface of the median pons without crossing the midline on DWI image, no severe stenosis (defined as \<70%) of parent artery. Patients will be randomly assigned into 2 groups: 1. Tirofiban + Aspirin (Day 1-90) 2. Placebo + Aspirin (Day 1-90) Interviews will be made on baseline, 24 hours after randomization, day 7 after randomization, discharge day, and day 90 after randomization.

Conditions

• Branch Atheromatous Disease

Interventions

Type	Name	Description
DRUG	Tirofiban hydrochloride sodium chloride injection	Day 1: Tirofiban will be given by bolus injection at 0.4ug/kg/min for the first 30 minutes, followed by a continuous infusion at 0.1ug/kg/min for the next 24 hours.
DRUG	Tirofiban hydrochloride sodium chloride injection placebo	Day 1: Tirofiban placebo will be injected at the same rate with experimental group.
DRUG	Aspirin	Day 1: Aspirin 100-300mg per day Day 2-90: Aspirin 100mg per day

Timeline

• Start date: 2022-11-12
• Primary completion: 2025-02-17
• Completion: 2025-09-01
• First posted: 2022-04-05
• Last updated: 2026-01-13

Locations

37 sites across 1 country: China