Tirofiban for Patients Treated With Alteplase
Overview
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.
Full Title of Study: “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
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: June 1, 2020
Interventions
- Drug: Tirofiban
- Tirofiban Injection after the alteplase intravenous thrombolysis
- Drug: Alteplase
- Only alteplase intravenous thrombolysis
Arms, Groups and Cohorts
- Experimental: Tirofiban and alteplase
- Placebo Comparator: Alteplase
Clinical Trial Outcome Measures
Primary Measures
- The rate of favorable outcome
- Time Frame: 90 days
- favorable outcome was defined as a score of 0, or 1 on the modified Rankin scale
Secondary Measures
- mRS ≤2
- Time Frame: 90 days
- NIHSS score
- Time Frame: 7 days
- Deterioration after improvement
- Time Frame: 24 hours
- Final infarct size
- Time Frame: 24 hours
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Capital Medical University
- Provider of Information About this Clinical Study
- Principal Investigator: Ji Xunming,MD,PhD, Principal Investigator – Capital Medical University
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.