Russian Prospective Multicenter Registry Study of Intravenous Thrombolytic Therapy for Acute Ischemic Stroke.

1. RATIONALE FOR THE STUDY 1.1. The urgency of the problem Cerebral stroke ranks second in the frequency of deaths from diseases of the circulatory system in the Russian Federation. Mortality rates from cerebrovascular diseases are among the highest in the world (175 per 100 thousand population) and, unlike most economically developed countries, not only do not decrease, but also tend to increase. The annual death rate from a stroke in Russia is one of the highest in the world (175 cases per 100 thousand population per year). The early 30-day mortality rate after stroke is 34.6%, and about 50% of patients die within a year, i.e. every second sick [1].

International experience shows that a decrease in mortality from cardiovascular diseases is achieved as a result of the implementation of coordinated complexes, the main of which are raising the awareness of the population about the risk factors of vascular diseases and their prevention, the introduction of effective preventive programs and the improvement of the system of medical care in stroke. stroke include the use of modern highly effective methods of reperfusion of the brain substance in the first hours of the disease, aimed at restoring blood flow in the affected vessel, which allows to prevent the development of irreversible damage to the brain substance or to reduce its volume, i.e. to minimize the severity of residual neurological deficit [2].

The safety and efficacy of systemic thrombolysis in ischemic stroke using rt-PA (alteplase) has been proven in a number of large randomized placebo-controlled clinical trials (NINDS, ECASS I, II, III, ATLANTIS) [3], as well as the SITS-MOST and SITS-ISTR registers [4 , 5]. According to the recommendations of the European Stroke Organization (ESO) and the American Stroke Association (ASA), systemic thrombolytic therapy (TLT) using rt-PA (alteplase) is the most effective treatment for ischemic stroke in the first 4.5 hours from the onset of the disease [6, 7].

1.2. Rationale for the study To date, two alteplase preparations are registered in the Russian Federation - Revelisa® (JSC GENERIUM, Russia) and Actilyse® (BoehringerIngelheimPharma GmbH and CoKG, Germany). The information obtained in this register will help to clarify the data on the use of thrombolytic therapy in patients with acute ischemic stroke in the Russian Federation. 2. PURPOSE AND OBJECTIVES OF THE RESEARCH 2.1. Purpose of the study The aim of this study is to collect and analyze data on patients with acute ischemic stroke during intravenous thrombolytic therapy with alteplase (Revelisa®) in routine clinical practice.

2.2. Research objectives

• Collecting and analyzing data on patients with acute stroke who received TLT in routine clinical practice;
• Obtaining data on the outcomes of AII in patients who received TLT in routine clinical practice;
• Obtaining data on the complications of TLT in patients with acute ischemic stroke in routine clinical practice.

3. RESEARCH DESIGN This study is an open, prospective, multicenter, non-interventional (registry) study.