Tirofiban for Patients Treated With Alteplase

NCT ID: NCT03357133

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-16
• Study Completion Date: 2020-08-31

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tirofiban and alteplase

Group Type: EXPERIMENTAL

Tirofiban

Intervention Type: DRUG

Tirofiban Injection after the alteplase intravenous thrombolysis

Alteplase

Group Type: PLACEBO_COMPARATOR

Alteplase

Intervention Type: DRUG

Only alteplase intravenous thrombolysis

Interventions

Tirofiban

Tirofiban Injection after the alteplase intravenous thrombolysis

Intervention Type: DRUG

Alteplase

Only alteplase intravenous thrombolysis

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Suzhou Municipal Hoapital

Suzhou, Anhui, China

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The Central Hospital of Luohe City

Luohe, Henan, China

Luzhou People's Hospital

Luzhou, Sichuan, China

Xiangtan Central Hospital

Xiangtan, , China

The Fifth Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Countries

China

Other Identifiers

2017032

Identifier Type: -

Identifier Source: org_study_id