Status:
TERMINATED
Tirofiban for Patients Treated With Alteplase
Lead Sponsor:
Capital Medical University
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 administr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03357133
Start Date
December 16 2017
End Date
August 31 2020
Last Update
September 9 2020
Active Locations (7)
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1
Suzhou Municipal Hoapital
Suzhou, Anhui, China
2
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053
3
The Central Hospital of Luohe City
Luohe, Henan, China
4
Luzhou People's Hospital
Luzhou, Sichuan, China