NCT03357133

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

December 16, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

2.5 years

First QC Date

November 23, 2017

Last Update Submit

September 6, 2020

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • The rate of favorable outcome

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

    90 days

Secondary Outcomes (4)

  • mRS ≤2

    90 days

  • NIHSS score

    7 days

  • Deterioration after improvement

    24 hours

  • Final infarct size

    24 hours

Other Outcomes (4)

  • Symptomatic intracranial hemorrhage

    7 days or discharge

  • Severe systemic bleeding

    7 days or discharge

  • Stroke-related death

    90 days

  • +1 more other outcomes

Study Arms (2)

Tirofiban and alteplase

EXPERIMENTAL
Drug: Tirofiban

Alteplase

PLACEBO COMPARATOR
Drug: Alteplase

Interventions

TirofibanDRUG

Tirofiban Injection after the alteplase intravenous thrombolysis

Tirofiban and alteplase
AlteplaseDRUG

Only alteplase intravenous thrombolysis

Alteplase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18
  • Ischemic stroke symptom with onset ≤4.5 hours treated with IV rt-PA according with local guidelines.
  • ≤ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Suzhou Municipal Hoapital

Suzhou, Anhui, China

Location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

The Central Hospital of Luohe City

Luohe, Henan, China

Location

Luzhou People's Hospital

Luzhou, Sichuan, China

Location

Xiangtan Central Hospital

Xiangtan, China

Location

The Fifth Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

TirofibanTissue Plasminogen Activator

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TyrosineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 23, 2017

First Posted

November 29, 2017

Study Start

December 16, 2017

Primary Completion

June 1, 2020

Study Completion

August 31, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

CN(7)