Tirofiban for Patients Treated With Alteplase

• Status: Terminated
• Trial end date: 2020-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Capital Medical University
• Treatments: Tirofiban; Tissue Plasminogen Activator

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