Study on Tirofiban With Aspirin in the Treatment of Acute Penetrating Artery Territory Infarction (NCT05310968) | Clinical Trial Compass
CompletedPhase 4
Study on Tirofiban With Aspirin in the Treatment of Acute Penetrating Artery Territory Infarction
China970 participantsStarted 2022-11-12
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 18-80 years old;
✓. Male or female;
✓. Within 48 hours of onset;
✓. Clinical symptoms and signs suggest acute single infarction of penetrating artery territory (no cortical involvement, no multifocal involvement, NIHSS ≤10 and consciousness-1a ≤1);
✓. DWI suggests single infarction (diameter \< 30mm) of penetrating artery territory which involves at least 2 axial layers, or its maximum diameter ≥15mm, or it is connected to the ventral surface of the pons, closing to but not crossing the midline, and located in one side;
✓. No severe stenosis (defined as \<70%) of parent artery;
✓. The patient or his / her legal representative is able and willing to sign the informed consent.
Exclusion criteria
✕. History of intracranial hemorrhage
✕. History of intracranial tumors, cerebral arteriovenous malformation, or aneurysm;
What they're measuring
1
new stroke or END(early neurological deterioration）
✕. Emergency endovascular intervention or intravenous thrombolysis before randomization;
✕. Dual antiplatelet therapy currently or within 14 days of randomization (excluding use of aspirin and clopidogrel after onset without loading dose of clopidogrel);
✕. Use of other antiplatelet drugs (ticagrelor, cilostazol, etc.), anticoagulant drugs, snake venom, defibrase, lumbrukinase or other defibrase treatments after onset;
✕. Expected long-term use of non-investigational antiplatelet drugs or non-steroidal anti-inflammatory drugs;
✕. With severe stenosis (\> 70%) of parent artery giving off responsible penetrating artery;
✕. Definite indications for anticoagulation (suspicion of cardioembolism, e.g. atrial fibrillation, known heart valve prosthesis, atrial myxoma, endocarditis, etc.) or indications for dual antiplatelet therapy (e.g. recent coronary or cerebral artery stent implantation);