Tirofiban for Patients Treated With Alteplase (MR TEA)

C

Capital Medical University

Status and phase

Terminated
Phase 3
Phase 2

Conditions

Ischemic Stroke

Treatments

Drug: Alteplase
Drug: Tirofiban

Study type

Interventional

Funder types

Other

Identifiers

NCT03357133
2017032

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

30 participants in 2 patient groups, including a placebo group

Tirofiban and alteplase
Experimental group
Treatment:
Drug: Tirofiban
Alteplase
Placebo Comparator group
Treatment:
Drug: Alteplase

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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