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Tirofiban for Patients Treated With Alteplase (MR TEA)

Primary Purpose

Ischemic Stroke

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tirofiban
Alteplase
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Suzhou Municipal Hoapital
  • Xuanwu Hospital, Capital Medical University
  • The Central Hospital of Luohe City
  • Luzhou People's Hospital
  • Xiangtan Central Hospital
  • The Fifth Affiliated Hospital of Zhengzhou University
  • The First Affiliated Hospital of Zhengzhou University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tirofiban and alteplase

Alteplase

Arm Description

Outcomes

Primary Outcome Measures

The rate of favorable outcome
favorable outcome was defined as a score of 0, or 1 on the modified Rankin scale

Secondary Outcome Measures

mRS ≤2
NIHSS score
Deterioration after improvement
Final infarct size

Full Information

First Posted
November 23, 2017
Last Updated
September 6, 2020
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03357133
Brief Title
Tirofiban for Patients Treated With Alteplase
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
The number and speed of enrollment were significantly less than expected.
Study Start Date
December 16, 2017 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tirofiban and alteplase
Arm Type
Experimental
Arm Title
Alteplase
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tirofiban
Intervention Description
Tirofiban Injection after the alteplase intravenous thrombolysis
Intervention Type
Drug
Intervention Name(s)
Alteplase
Intervention Description
Only alteplase intravenous thrombolysis
Primary Outcome Measure Information:
Title
The rate of favorable outcome
Description
favorable outcome was defined as a score of 0, or 1 on the modified Rankin scale
Time Frame
90 days
Secondary Outcome Measure Information:
Title
mRS ≤2
Time Frame
90 days
Title
NIHSS score
Time Frame
7 days
Title
Deterioration after improvement
Time Frame
24 hours
Title
Final infarct size
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Symptomatic intracranial hemorrhage
Time Frame
7 days or discharge
Title
Severe systemic bleeding
Time Frame
7 days or discharge
Title
Stroke-related death
Time Frame
90 days
Title
Death form any cause
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Suzhou Municipal Hoapital
City
Suzhou
State/Province
An Hui
Country
China
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
The Central Hospital of Luohe City
City
Luohe
State/Province
Henan
Country
China
Facility Name
Luzhou People's Hospital
City
Luzhou
State/Province
Sichuan
Country
China
Facility Name
Xiangtan Central Hospital
City
Xiangtan
Country
China
Facility Name
The Fifth Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China

12. IPD Sharing Statement

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Tirofiban for Patients Treated With Alteplase

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