Tirofiban for Patients Treated With Alteplase

Ischemic Stroke Clinical Trial

— MR TEA  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03357133
• Other study ID #: 2017032
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: December 16, 2017
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2020
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: August 31, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Tirofiban
Tirofiban Injection after the alteplase intravenous thrombolysis
• Alteplase
Only alteplase intravenous thrombolysis

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing
China	The Central Hospital of Luohe City	Luohe	Henan
China	Luzhou People's Hospital	Luzhou	Sichuan
China	Suzhou Municipal Hoapital	Suzhou	An Hui
China	Xiangtan Central Hospital	Xiangtan
China	The Fifth Affiliated Hospital of Zhengzhou University	Zhengzhou
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptomatic intracranial hemorrhage		7 days or discharge
Other	Severe systemic bleeding		7 days or discharge
Other	Stroke-related death		90 days
Other	Death form any cause		90 days
Primary	The rate of favorable outcome	favorable outcome was defined as a score of 0, or 1 on the modified Rankin scale	90 days
Secondary	mRS =2		90 days
Secondary	NIHSS score		7 days
Secondary	Deterioration after improvement		24 hours
Secondary	Final infarct size		24 hours