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

• ClinicalTrials.gov Identifier: NCT03654157
• Recruitment Status: Completed
• First Posted: August 31, 2018
• Last Update Posted: October 14, 2022
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

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
• 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.

Condition

• Heart Attack
• Stroke
• Cardiovascular Death

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• Davies MJ. The pathophysiology of acute coronary syndromes. Heart. 2000 Mar;83(3):361-6. doi: 10.1136/heart.83.3.361. No abstract available.
• Task Force for Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of European Society of Cardiology; Bassand JP, Hamm CW, Ardissino D, Boersma E, Budaj A, Fernandez-Aviles F, Fox KA, Hasdai D, Ohman EM, Wallentin L, Wijns W. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J. 2007 Jul;28(13):1598-660. doi: 10.1093/eurheartj/ehm161. Epub 2007 Jun 14. No abstract available.
• Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE 3rd, Steward DE, Theroux P, Alpert JS, Eagle KA, Faxon DP, Fuster V, Gardner TJ, Gregoratos G, Russell RO, Smith SC Jr. ACC/AHA guidelines for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Unstable Angina). J Am Coll Cardiol. 2000 Sep;36(3):970-1062. doi: 10.1016/s0735-1097(00)00889-5. No abstract available. Erratum In: J Am Coll Cardiol 2001 Jul;38(1):294-5.
• Vasilyeva EY, Plavunov NF, Kalinskaya AI, Sapina AI, Vvedensky GA, Lebedeva AY, Skrypnyk DV, Shpektor AV. [Treatment of Patients With Acute Myocardial Infarction With ST-Segment Elevation. Organization of the Myocardial Infarction Network in Moscow]. Kardiologiia. 2016 Dec;56(12):48-53. No abstract available. Russian.
• Jernberg T, Hasvold P, Henriksson M, Hjelm H, Thuresson M, Janzon M. Cardiovascular risk in post-myocardial infarction patients: nationwide real world data demonstrate the importance of a long-term perspective. Eur Heart J. 2015 May 14;36(19):1163-70. doi: 10.1093/eurheartj/ehu505. Epub 2015 Jan 13.
• Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
• Hicks KA, Tcheng JE, Bozkurt B, Chaitman BR, Cutlip DE, Farb A, Fonarow GC, Jacobs JP, Jaff MR, Lichtman JH, Limacher MC, Mahaffey KW, Mehran R, Nissen SE, Smith EE, Targum SL. 2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards). J Am Coll Cardiol. 2015 Jul 28;66(4):403-69. doi: 10.1016/j.jacc.2014.12.018. Epub 2014 Dec 29. No abstract available. Erratum In: J Am Coll Cardiol. 2015 Aug 25;66(8):982.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 9, 2022): 1576
• Original Estimated Enrollment (submitted: August 29, 2018): 2500
• 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

Sex/Gender

• 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

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

Investigators

• 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