NCT03357133TerminatedPhase 2
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
Capital Medical University7 sites in 1 country30 target enrollmentStarted: December 16, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 30
- Locations
- 7
- Primary Endpoint
- The rate of favorable outcome
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Known allergic to tirofiban or other glycoprotein IIb/IIIa antagonist.
- •Severe non-cerebrovascular disease with life expectancy <3 months
Arms & Interventions
Tirofiban and alteplase
Experimental
Intervention: Tirofiban (Drug)
Alteplase
Placebo Comparator
Intervention: Alteplase (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- mRS ≤2(90 days)
- NIHSS score(7 days)
- Deterioration after improvement(24 hours)
- Final infarct size(24 hours)
Investigators
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University
Study Sites (7)
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