Tirofiban for Patients Treated With Alteplase (MR TEA)

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

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 Overview

• Status: Terminated
• Conditions: Ischemic Stroke
• Intervention / Treatment: Drug: Tirofiban; Drug: Alteplase

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Xiangtan, China
    • Xiangtan Central Hospital
  • Zhengzhou, China
    • The First Affiliated Hospital of Zhengzhou University
  • Zhengzhou, China
    • The fifth Affiliated Hospital of Zhengzhou University
  • An Hui
    • Suzhou, An Hui, China
      • Suzhou Municipal Hoapital
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital, Capital Medical University
  • Henan
    • Luohe, Henan, China
      • The Central Hospital of Luohe City
  • Sichuan
    • Luzhou, Sichuan, China
      • Luzhou People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tirofiban and alteplase	Drug: Tirofiban; Tirofiban Injection after the alteplase intravenous thrombolysis
Placebo Comparator: Alteplase	Drug: Alteplase; Only alteplase intravenous thrombolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of favorable outcome	favorable outcome was defined as a score of 0, or 1 on the modified Rankin scale	90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
mRS ≤2	90 days
NIHSS score	7 days
Deterioration after improvement	24 hours
Final infarct size	24 hours

Other Outcome Measures

Outcome Measure	Time Frame
Symptomatic intracranial hemorrhage	7 days or discharge
Severe systemic bleeding	7 days or discharge
Stroke-related death	90 days
Death form any cause	90 days

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2017
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: November 23, 2017
• First Submitted That Met QC Criteria: November 23, 2017
• First Posted (Actual): November 29, 2017

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 6, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Tirofiban; Tissue Plasminogen Activator
• Other Study ID Numbers: 2017032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No