Study on Tirofiban With Aspirin in the Treatment of Acute Penetrating Artery Territory Infarction (STRATEGY)
Branch Atheromatous Disease
About this trial
This is an interventional treatment trial for Branch Atheromatous Disease focused on measuring branch atheromatous disease, perforating artery territorial infarction, tirofiban, aspirin, randomized controlled trial, multicenter study, double blind study, placebo-controlled
Eligibility Criteria
Inclusion Criteria:
- 18-80 years old;
- No gender limitation;
- 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 (basal ganglia, internal capsule, thalamus, pons, etc.), 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 giving off the responsible penetrating artery;
- The patient or his / her legal representative is able and willing to sign the informed consent.
Exclusion Criteria:
- History of intracranial hemorrhage (subarachnoid hemorrhage and cerebral hemorrhage);
- History of intracranial tumors, cerebral arteriovenous malformation, or aneurysm;
- 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 definite indications for dual antiplatelet therapy (e.g. recent coronary or cerebral artery stent implantation);
- Severe hepatic or renal insufficiency before randomization (severe hepatic insufficiency refers to ALT or AST > 3 times the upper limit of normal; severe renal insufficiency refers to creatinine clearance rate (CCr) < 30ml/min);
- Hemorrhagic tendency (including but not limited to):PLT<100×109/L; heparin treatment within 48h; APTT ≥ 35s; current use of warfarin, INR > 1.7; current use of novel oral anticoagulants; current use of direct thrombin or factor Xa inhibitor;
- Resistant hypertension which could not be controlled by medicine (SBP > 180mmHg or DBP > 110mmHg);
- History of obvious head trauma or stroke within three months of randomization;
- History of intracranial or intramedullary surgery within three months of randomization;
- History of major surgery or severe physical trauma within one month of randomization;
- Severe neurological defects (mRS ≥ 2) before the onset;
- Acute pericarditis;
- Hemorrhagic retinopathy;
- Childbearing-age women who do not take effective methods of contraception without negative records of pregnancy tests;
- Known to be allergic to tirofiban;
- Other surgical or interventional therapy planned within 3 months requiring experimental drugs discontinuation;
- Life expectancy < 6 months due to any terminal illness;
- Patients who are undergoing experimental drugs or instruments;
- Other conditions which suggest participants are unsuitable for this study, e.g. inability for understanding and / or obeying research procedures and / or follow-up due to mental diseases, cognitive or mood disturbance, or with MRI contraindications, etc.
Sites / Locations
- Beijing HospitalRecruiting
- The Affiliated Dongnan Hospital of Xiamen UniversityRecruiting
- Hejian People's HospitalRecruiting
- The People's Hospital of Qinghe CountyRecruiting
- Mengzhou People's HospitalRecruiting
- The People's Hospital of Xiuwu CountyRecruiting
- Traditional Chinese Medicine Hospital of Jiyuan CityRecruiting
- The First People's Hospital of NanyangRecruiting
- The People's Hospital of Tanghe CountyRecruiting
- Traditional Chinese Medicine Hospital of Sui CountyRecruiting
- The People's Hospital of Biyang CountyRecruiting
- Shaodong People's HospitalRecruiting
- The Third People's Hospital of Tongzhou District, Nantong CityRecruiting
- The First People's Hospital of XianyangRecruiting
- Liaocheng Central HospitalRecruiting
- The People's Hospital of Guan CountyRecruiting
- The Third People's Hospital of LiaochengRecruiting
- Weihai Wendeng District People's HospitalRecruiting
- Changzhi People's HospitalRecruiting
- The People's Hospital of Wanrong CountyRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Tirofiban group
Tirofiban placebo group
This group will receive tirofiban and aspirin. Day 1: Tirofiban injected intravenously for 24 hours and aspirin of 100-300 mg. Tirofiban will be injected at 4 ug/kg/ min for the first 30 minutes and 0.1 ug/kg/min for the next 24 hours. Day 2-90: Aspirin 100mg per day.
This group will receive tirofiban placebo and aspirin. Day 1: Tirofiban placebo injected intravenously for 24 hours and aspirin of 100-300 mg. The placebo will be injected at the same rate with Tirofiban group. Day 2-90: Aspirin 100mg per day.