Prospective pilot study of tirofiban in progressive stroke after intravenous thrombolysis

Between this and all this earlier research we should be able to come up with a protocol.  WHAT EXACT PERSON DO WE CONTACT TO GET THIS WORK DONE?

Other earlier research your doctor and hospital should consider. 

Safety of Tirofiban in acute Ischemic Stroke: the SaTIS trial

Safety and preliminary efficacy of early tirofiban treatment after alteplase in acute ischemic stroke patients

Tirofiban for acute ischemic stroke: systematic review and meta-analysis

Endovascular stroke therapy: tirofiban is associated with risk of fatal intracerebral hemorrhage and poor outcome

Efficacy and Safety of Tirofiban in Clinical Patients With Acute Ischemic Stroke

 

The latest here:

Prospective pilot study of tirofiban in progressive stroke after intravenous thrombolysis

Yan Zhang^1*, Jianliang Wang², Zhaoxi Ma¹, Guihua Mu¹, Da Liang¹, Yifan Li¹, Xiaoyan Qian¹, Luyuan Zhang³, Fang Shen⁴, Lei Zhang¹, Jie Yu⁵ and Yang Liu^6*

• ¹Department of Neurology, The Kunshan Affiliated Hospital of Jiangsu University, The First People's Hospital of Kunshan, Kunshan, China
• ²Department of Radiology, The Kunshan Affiliated Hospital of Jiangsu University, The First People's Hospital of Kunshan, Kunshan, China
• ³Department of Scientific and Technological Talents, The Kunshan Affiliated Hospital of Jiangsu University, The First People's Hospital of Kunshan, Kunshan, China
• ⁴Department of Outpatient, The Kunshan Affiliated Hospital of Jiangsu University, The First People's Hospital of Kunshan, Kunshan, China
• ⁵Department of Neurology, The Second People's Hospital of Kunshan, Kunshan, China
• ⁶Department of Neurology, Saarland University, Homburg, Germany

Background: Intravenous thrombolysis (IVT) is a standard procedure for the treatment of patients with acute ischemic stroke (AIS). Improving the therapeutic efficacy of IVT is an important task for neurologists. The aim of this study was to evaluate the efficacy and safety of early low-dose tirofiban treatment in AIS patients with early neurological deterioration (END) after IVT.

Methods: In this prospective and randomized pilot study, 73 AIS patients with END were recruited from a local hospital in China. Of these, 14 patients were treated with regular antiplatelet agents (aspirin plus clopidogrel) and 59 patients were treated with tirofiban within 24 h of IVT, followed by regular antiplatelet therapy. Neurological deficits and functional recovery were assessed with NIHSS and modified Rankin Scale (mRS) at 7 and 90 days. During the 90-day follow-up period, both hemorrhagic (e.g., intracerebral hemorrhage) and non-hemorrhagic (e.g., pneumonia) events were recorded.

Results: Treatment with tirofiban compared with regular antiplatelet therapy: (1) improved functional recovery of AIS patients to mRS (≤2) at both 7 and 90 days (odds ratios [ORs], 1.37 and 1.64; 95% confidence interval [CI], 1.16–1.61 and 1.26–2.12; P = 0.008 and < 0.001, respectively), and (2) reduced NIHSS scores from 11.14 ± 2.38 to 5.95 ± 3.48 at day 7 (P < 0.001) and from 8.14 ± 2.74 to 4.08 ± 3.50 at day 90 (P < 0.001). Tirofiban treatment did not increase the risk of hemorrhagic complications. Multivariate regression analysis showed that tirofiban treatment independently predicted a favorable functional outcome (P ≤ 0.001).

Conclusion: Early treatment with low-dose tirofiban in AIS patients with neurologic deterioration after IVT potentially improved functional recovery and attenuated neurologic deficits as early as 7 days and did not increase the risk of various hemorrhagic complications. However, the therapeutic efficacy of tirofiban treatment in END patients needs to be determined by future randomized clinical trials with a large study population.

Clinical trial registration: http://www.chictr.org.cn/, Identifier ChiCTR2200058513.

Background

Acute ischemic stroke (AIS) is a leading cause of disability and death in China and worldwide (1, 2). Intravenous thrombolysis or/and intraarterial thrombectomy to reopen occluded cerebral arteries is a standard treatment procedure for AIS patients. There is evidence that thrombectomy has a higher recanalization rate than thrombolysis in large vessels; however, endovascular therapy can only be performed in selected high-performing stroke centers. In smaller hospitals, especially in rural areas, intravenous thrombolysis with recombinant tissue-type plasminogen activator (rt-PA) remains the mainstay for AIS patients (3, 4). Further studies on how to improve the therapeutic efficacy of intravenous thrombolysis are always important.

Early neurological deterioration (END) within the first 24 h after intravenous thrombolysis is a major problem leading to poor outcomes in AIS patients (5). Using the definition of a National Institutes of Health Stroke Scale (NIHSS) change ≥4, the incidence of END after thrombolysis is approximately 14% (6). The pathogenic mechanisms mediating END are largely unknown, and specific medical treatments that prevent or reverse END are lacking. Recently, it has been suggested that extension of the initial thrombus or new embolic events in the same ischemic brain region may further impair brain perfusion and cause END in AIS patients. Therefore, antiplatelet therapy that stops thrombus formation may be helpful to prevent END (5).

Tirofiban is a non-peptide antagonist of the major platelet surface receptor glycoprotein IIb/IIIa. It prevents fibrinogen from binding to glycoprotein IIb/IIIa, thus blocking platelet aggregation. Its half-life in plasma is 1.5–2 h. After discontinuation of tirofiban administration, platelet aggregation recovers to 50% of baseline within 4 h (7). Interestingly, a recent multicenter retrospective study showed that the use of tirofiban at a low dose in patients with END within the first 24 h after intravenous thrombolysis improves functional outcome at 3 months, as assessed by the modified Rankin Scale (mRS), and does not increase the risk of intracerebral hemorrhage (8). In another study, early administration of tirofiban after intravenous thrombolysis (within 2 or 12 h) showed better efficacy than late administration (after 12 h) in reducing NIHSS and mRS within 2 weeks and at 3 months (9).

In our prospective pilot study, we selected AIS patients with END with an NIHSS increase ≥4 within 24 h after intravenous thrombolysis as the study subjects and treated them with a low dose of tirofiban for up to 24 h followed by regular antithrombotic drugs (e.g., aspirin and clopidogrel). The aim of our study was to investigate whether treatment with tirofiban prevents further neurological deterioration and improves functional recovery in AIS patients with END.

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