MR TEA: Tirofiban for Patients Treated With Alteplase
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- The rate of favorable outcome [90 days]
favorable outcome was defined as a score of 0, or 1 on the modified Rankin scale
Secondary Outcome Measures
- mRS ≤2 [90 days]
- NIHSS score [7 days]
- Deterioration after improvement [24 hours]
- Final infarct size [24 hours]
Other Outcome Measures
- Symptomatic intracranial hemorrhage [7 days or discharge]
- Severe systemic bleeding [7 days or discharge]
- Stroke-related death [90 days]
- Death form any cause [90 days]
Eligibility Criteria
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.
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Patients had used anticoagulant therapy in the past 5 days before the stroke.
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Scheduled for surgery or interventional treatment requiring study drug cessation.
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CT scan finding of hypoattenuation involving ≥1/3 of the MCA territory.
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Any evidence of clinically significant bleeding ,or known coagulopathy.
-
Renal insufficiency (creatinine clearance rate <30ml/min)
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Suzhou Municipal Hoapital | Suzhou | An Hui | China | |
| 2 | Xuanwu Hospital, Capital Medical University | Beijing | Beijing | China | 100053 |
| 3 | The Central Hospital of Luohe City | Luohe | Henan | China | |
| 4 | Luzhou People's Hospital | Luzhou | Sichuan | China | |
| 5 | Xiangtan Central Hospital | Xiangtan | China | ||
| 6 | The Fifth Affiliated Hospital of Zhengzhou University | Zhengzhou | China | ||
| 7 | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | China |
Sponsors and Collaborators
- Capital Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017032