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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03654157
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : October 14, 2022
Information provided by (Responsible Party):

Tracking Information
First Submitted Date August 29, 2018
First Posted Date August 31, 2018
Last Update Posted Date October 14, 2022
Actual Study Start Date March 25, 2018
Actual Primary Completion Date October 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 29, 2018)
the cumulative incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACСE) [ Time Frame: 1 year ]
The primary objective of this study is to describe the cumulative incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACСE) [MI, stroke, and cardiovascular death] observed over 1 year after index MI in all patients enrolled in the study.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title ACS Registry - A Non-interventional Study to Estimate the Rates of Outcomes in ACS Patients in Moscow
Official Title A Non-interventional Study to Estimate the Rates of Outcomes in ACS Patients in Moscow
Brief 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

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All consecutive patients who survived myocardial infarction and who come for further treatment and observation to polyclinic after discharge from hospital will be enrolled in this study if a patient provides a consent form. It is estimated that at least 2500 post MI patients are to be enrolled in the study. It is also assumed that the total size of the study population could be up to 10 000 post MI patients who are observed in polyclinics of Moscow city within first year after index event.
  • Heart Attack
  • Stroke
  • Cardiovascular Death
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 9, 2022)
Original Estimated Enrollment
 (submitted: August 29, 2018)
Actual Study Completion Date October 19, 2021
Actual Primary Completion Date October 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

The subject population that will be observed in this prospective study must meet the following criteria:

  1. Patients survivors who visited outpatient setting after discharge from hospital due to MI (STEMI or NSTEMI) within 1 month after discharge from hospital;
  2. Obtained written informed consent for participation in this study.
  3. Age of 18 year or older.

Exclusion Criteria:

  1. Current participation in a clinical study.
  2. Unknown type of MI
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Russian Federation
Removed Location Countries  
Administrative Information
NCT Number NCT03654157
Other Study ID Numbers D1843R00279
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Current Responsible Party AstraZeneca
Original Responsible Party Same as current
Current Study Sponsor AstraZeneca
Original Study Sponsor Same as current
Collaborators Not Provided
Principal Investigator: Olga Pesheva GBUZ GP # 121 DZM
Principal Investigator: Tatyana Yurchak GBUZ GP # 52 DZM
Principal Investigator: Veronika Vovk GBUZ GP # 2 DZM
Principal Investigator: Dmitriy Privalov GBUZ GKB # 51 DZM
Principal Investigator: Maria Klepikova GBUZ GKB # 13 DZM
Principal Investigator: Olga Belkorey GBUZ GP # 218 DZM
Principal Investigator: Natalya Karabinskaya GBUZ GP # 19 DZM
Principal Investigator: Natalya Bosyakova GBUZ GP # 19 DZM
Principal Investigator: Marina Lepatova GBUZ GP # 107 DZM
Principal Investigator: Elena Dorofeeva FGBU "Polyclinic # 1" Administrative Department of the President of the Russian Federation
Principal Investigator: Irina Shoshina GBUZ GP # 109 DZM
Principal Investigator: Darya Semenova GBUZ GP # 23 DZM
Principal Investigator: Elena Zherebetskaya GBUZ KDC # 2 DZM
Principal Investigator: Marina Yarygina GBUZ GP # 175 DZM
Principal Investigator: Elena Lukinskaya GBUZ GP # 115 DZM
Principal Investigator: Irina Borovikova GBUZ GP # 209 DZM
Principal Investigator: Tatiana Sladkova GBUZ GP # 22 DZM
Principal Investigator: Elena Demyanova GBUZ GP # 64 DZM
PRS Account AstraZeneca
Verification Date October 2022