Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04674293 |
| Other study ID # |
IVT-AIS-R |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
January 1, 2022 |
Study information
| Verified date |
December 2020 |
| Source |
Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Russian prospective multicenter registry study of intravenous thrombolytic therapy for acute
ischemic stroke.
Description:
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.
This study does not provide for any interference with normal clinical practice,
including the use of investigational therapy or special research methods. The physician
will collect data on all patients with acute ischemic stroke who are admitted to the
hospital and who meet the inclusion criteria for this study, starting from 1 July 2019.
4. SELECTION AND EXCLUSION OF RESEARCH SUBJECTS 4.1. Description of the study population
The study will include all patients of any gender and age with a confirmed diagnosis of
stroke of ischemic type (AII) who meet the selection criteria for the study and
hospitalized in specialized hospitals. At least 500 patients are planned to be included
in the study.
4.2. Inclusion criteria
To be included in the study, patients must meet the following criteria:
1. Patients of any gender and age with a confirmed diagnosis of ischemic stroke (AII);
2. Carrying out the patient with intravenous thrombolytic therapy with the drug alteplase
(Revelisa®).
5. SURVEY MANAGEMENT The principal investigators of the centers are responsible for
conducting research at each specific clinical center. The national project coordinator is
prof. Shamalov N.A. Operational project management and statistical analysis is carried out by
Generium JSC, database maintenance and data management will be carried out on the basis of
the ROSMED.INFO online medical platform, medical monitoring will be carried out by the
Federal Center for Cerebrovascular Pathology and Stroke of the Ministry of Health of the
Russian Federation.
6. THERAPY The use of any investigational drug is not foreseen in this register. All patients
included in the study will receive thrombolytic therapy with drugs registered in the Russian
Federation, and in accordance with
