CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,576 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT03654157
NCT03654157N/ACompleted

A Non-interventional Study to Estimate the Rates of Outcomes in ACS Patients in Moscow

AstraZeneca·observational·Posted Aug 31, 2018·Updated Oct 14, 2022

In Brief

An observational study for Heart Attack and 2 related conditions. Completed, enrolled 1,576 participants across 27 sites.

Detailed Summary

Cardiovascular diseases (CVD) are currently the leading cause of death in industrialized countries and are expected to become the leading cause of death in emerging countries by 20201. According to the official Russian statistics, in 2015, CVD was the cause in 34% of deaths in Russia2. Acute Coronary Syndrome (ACS) is the most prevalent manifestation of CVD and is associated with high mortality and morbidity. No other life-threatening disease is as prevalent or expensive to society3. In 2014 in Russian Federation 46 250 people died from acute myocardial infarction (MI) and 17 605 people died from recurrent MI4. ACS is a clinical syndrome characterized by unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI). The most common cause of ACS is reduced myocardial perfusion that results from coronary artery narrowing caused by the formation of partially or totally occlusive thrombi in response to rupture of atherosclerotic plaques on the vessel wall5-7. In Russian Federation ACS management after ACS is provided in out-patient settings by doctors of different specialties (cardiologists and general practitioners (GPs)). However, the management of ACS in out-patient settings in some regions in Russian Federation is frequently suboptimal. Moscow city significantly differs from other parts of Russia from ACS management at hospital stage (up to 90% of PCI managed ST elevation myocardial infarction (MI) patients, no thrombolysis, short first medical contact to balloon time etc.) but it is unclear if management of post MI patients in Moscow out-patient settings is also optimal. In-hospital mortality in MI patients decreased last years but there is no data on clinical outcomes during 12 months after MI in Moscow. This study will provide the epidemiological data about rates of major adverse cardiovascular and cerebrovascular events (MACCE) (MI, stroke, cardiovascular death) within 12 months after MI in real clinical practice in Moscow and describe DAPT at out-patient setting. The information received in this study will help to optimize management of Russian patients with ACS. The data will be used in discussion with payers

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesRussia
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 31, 2018
Enrollment StartMar 25, 2018
Primary CompletionOct 19, 2021
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.8 years ago