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Tirofiban for Patients Treated With Alteplase (MR TEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03357133
Recruitment Status : Terminated (The number and speed of enrollment were significantly less than expected.)
First Posted : November 29, 2017
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Ji Xunming,MD,PhD, 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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: Tirofiban Drug: Alteplase Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 16, 2017
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. The rate of favorable outcome [ Time Frame: 90 days ]
    favorable outcome was defined as a score of 0, or 1 on the modified Rankin scale


Secondary Outcome Measures :
  1. mRS ≤2 [ Time Frame: 90 days ]
  2. NIHSS score [ Time Frame: 7 days ]
  3. Deterioration after improvement [ Time Frame: 24 hours ]
  4. Final infarct size [ Time Frame: 24 hours ]

Other Outcome Measures:
  1. Symptomatic intracranial hemorrhage [ Time Frame: 7 days or discharge ]
  2. Severe systemic bleeding [ Time Frame: 7 days or discharge ]
  3. Stroke-related death [ Time Frame: 90 days ]
  4. Death form any cause [ Time Frame: 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357133


Locations
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China, An Hui
Suzhou Municipal Hoapital
Suzhou, An Hui, China
China, Beijing
Xuanwu Hospital, Capital Medical University
Beijing, Beijing, China, 100053
China, Henan
The Central Hospital of Luohe City
Luohe, Henan, China
China, Sichuan
Luzhou People's Hospital
Luzhou, Sichuan, China
China
Xiangtan Central Hospital
Xiangtan, China
The Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Sponsors and Collaborators
Capital Medical University
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Responsible Party: Ji Xunming,MD,PhD, Principal Investigator, Capital Medical University
ClinicalTrials.gov Identifier: NCT03357133    
Other Study ID Numbers: 2017032
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Tissue Plasminogen Activator
Tirofiban
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors