Tirofiban for Patients Treated With Alteplase

Phase 2

Terminated

• Conditions: Ischemic Stroke
• Interventions: Drug: Alteplase; Drug: Tirofiban

• Registration Number: NCT03357133
• Lead Sponsor: Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-23
• Study First Submitted QC: 2017-11-23
• Study First Posted: 2017-11-29
• Study Start: 2017-12-16
• Primary Completion: 2020-06-01
• Study Completion: 2020-08-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-06
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alteplase	Alteplase	-
Tirofiban and alteplase	Tirofiban	-

Primary Outcome Measures

Name	Time	Method
The rate of favorable outcome	90 days	favorable outcome was defined as a score of 0, or 1 on the modified Rankin scale

Secondary Outcome Measures

Name	Time	Method
NIHSS score	7 days
mRS ≤2	90 days
Deterioration after improvement	24 hours
Final infarct size	24 hours

Trial Locations

Locations (7)

The Fifth Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Luzhou People's Hospital; 🇨🇳 Luzhou, Sichuan, China

Xiangtan Central Hospital; 🇨🇳 Xiangtan, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China

Suzhou Municipal Hoapital; 🇨🇳 Suzhou, An Hui, China

The Central Hospital of Luohe City; 🇨🇳 Luohe, Henan, China