Primary Prevention With Statin and Incidence of Recurrent MI and Cardiogenic Shock in Post-ACS Patients

NCT03596944 | Completed

• 1 other identifier: APS005
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of statin for primary prevention, towards lowering the incidence of recurrent myocardial infarction, cardiogenic shock and mortality in ACS patients.

Conditions

Acute Coronary Syndrome; Recurrent Myocardial Infarction; Cardiogenic Shock

Keywords

acute coronary syndrome; statin; mortality; GRACE score; TIMI score

Outcome Measures

Primary Outcomes (3)

• Recurrent Myocardial Infarction

  Clinical Diagnosis of Recurrent Myocardial Infarction reported in medical records

  Through study completion, an average of 1 year

• Cardiogenic Shock

  Clinical Diagnosis of Cardiogenic Shock reported in medical records

  Through study completion, an average of 1 year

• Mortality

  Patient death reported in medical records

  Through study completion, an average of 1 year

Other Outcomes (2)

• GRACE Score

  Through study completion, an average of 1 year

• TIMI Score

  Through study completion, an average of 1 year

Study Arms (2)

Statin

History of statin use for primary prevention

Drug: Statin

Non-Statin

No documented history of statin use prior to Acute Coronary Syndrome

Interventions

Statin DRUG

Prescribed with statins for primary prevention

Statin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥ 18 years of age) with acute coronary syndrome which are diagnosed under International Classification of Diseases (ICD)10 coding of I24.9

You may qualify if:

• Clinical diagnosis of Acute Coronary Syndrome
• Presence of detail on statin prescription history

You may not qualify if:

• Unavailability of electrocardiographic findings, cardiac marker results, GRACE and TIMI score parameters
• Incomplete records of prior medical and treatment history

Sponsors & Collaborators

• Tarumanagara University: lead
• Cengkareng General Hospital: collaborator

Study Sites (1)

Cengkareng General Hospital

Jakarta, DKI Jakarta, Indonesia

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction; Shock, Cardiogenic

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Angela F Sunjaya

  Tarumanagara University

  STUDY CHAIR

• Anthony P Sunjaya

  Tarumanagara University

  PRINCIPAL INVESTIGATOR

• Andria Priyana, MD, FIHA

  Department of Cardiology, Faculty of Medicine, Tarumanagara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 24, 2018
• Study Start: August 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: August 31, 2018
• Last Updated: September 12, 2018

Record last verified: 2018-09

Locations

ID (1)