Clinical trial NCT03357133: Tirofiban for Patients Treated With Alteplase
Official title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Early Administration of Tirofiban in Acute Ischemic Stroke Patients Treated With Intravenous Alteplase Thrombolysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Ischemic Stroke
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After intravenous thrombolysis, the overall recanalization rate is 46%, and recclusion after initial recanalization occurs in 14-34%. In the MR TEA, the investigators compared the effects of administration of tirofiban in acute ischemic stroke patients treated with intravenous alteplase thrombolysis with alteplase alone.


Eligibility criteria: Inclusion Criteria:

* Age ≥18
* Ischemic stroke symptom with onset ≤4.5 hours treated with IV rt-PA according with local guidelines.
* 6≤ NIHSS ≤20 before IV tPA, or NIHSS \>20 but decrease ≥ 8 after IV rt-PA.
* ≥ 4 point total NIHSS or ≥ 2 point in one NIHSS category during and after the IV rt-PA compared to immediately before worsening, an emergency CT scan should be performed to exclude intracranial hemorrhage
* Patients or their legally acceptable representative agreed to the treatment and signed the informed consent form

Exclusion Criteria:

* Patients whom the treating physician is planning to treat with mechanical thrombectomy or other endovascular procedure (e.g. Intra-arterial thrombolysis) according with local guidelines.
* Patients had used antiplatelet therapy in the past 5 days before the stroke.
* Patients had used anticoagulant therapy in the past 5 days before the stroke.
* Scheduled for surgery or interventional treatment requiring study drug cessation.
* CT scan finding of hypoattenuation involving ≥1/3 of the MCA territory.
* Any evidence of clinically significant bleeding ,or known coagulopathy.
* Renal insufficiency (creatinine clearance rate \<30ml/min)
* Hepatic dysfunction (ALT \>2 folds of Upper limit of normal value or AST\>2 folds of Upper limit of normal value).
* Pre-existing disability with ≥ mRS 2.
* Known allergic to tirofiban or other glycoprotein IIb/IIIa antagonist.
* Severe non-cerebrovascular disease with life expectancy \<3 months

Primary outcomes:
measure: The rate of favorable outcome
timeFrame: 90 days
Secondary outcomes:
measure: mRS ≤2
timeFrame: 90 days
measure: NIHSS score
timeFrame: 7 days
measure: Deterioration after improvement
timeFrame: 24 hours
measure: Final infarct size
timeFrame: 24 hours
Other outcomes:
measure: Symptomatic intracranial hemorrhage
timeFrame: 7 days or discharge
measure: Severe systemic bleeding
timeFrame: 7 days or discharge
measure: Stroke-related death
timeFrame: 90 days
measure: Death form any cause
timeFrame: 90 days
Locations:
city: Suzhou
country: China
facility: Suzhou Municipal Hoapital
state: An Hui
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Luohe
country: China
facility: The Central Hospital of Luohe City
state: Henan
city: Luzhou
country: China
facility: Luzhou People's Hospital
state: Sichuan
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
city: Zhengzhou
country: China
facility: The Fifth Affiliated Hospital of Zhengzhou University
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
References: