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OpenTrials
Completed

NCT Number: NCT03596944

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

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.

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Key information

About this study

Adult patients (≥ 18 years of age) with acute coronary syndrome which are diagnosed under ICD-10 coding of I24.9 were included in this study. The inclusion criteria are patients with primary diagnosis of I24.9 and with a complete record of prior medical and treatment history, electrocardiographic findings, cardiac marker results and outcomes. Participants were grouped into 2 groups - statin and non-statin based on prior history of statin use prior to ACS. Diagnosis of ACS was made based on clinical, electrocardiographic and cardiac marker findings found in the medical record.

Data such as age, sex, ethnic, education, prior medical and treatment history, electrocardiographic and cardiac enzyme results as well as outcomes were collected from the patients' medical records. Outcomes of interest were defined as either recurrent myocardial infarction, cardiogenic shock, mortality or combinations of them as diagnosed in the medical records. GRACE and TIMI Scores are calculated to predict in hospital and future mortality rates.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Statin

Drug

Prescribed with statins for primary prevention

Primary outcomes

  1. Recurrent Myocardial Infarction

    Time frame: Through study completion, an average of 1 year

    Clinical Diagnosis of Recurrent Myocardial Infarction reported in medical records

  2. Cardiogenic Shock

    Time frame: Through study completion, an average of 1 year

    Clinical Diagnosis of Cardiogenic Shock reported in medical records

  3. Mortality

    Time frame: Through study completion, an average of 1 year

    Patient death reported in medical records

Other outcomes

  1. GRACE Score

    Time frame: Through study completion, an average of 1 year

    GRACE (Global Registry of Acute Coronary Events) mortality risk score

  2. TIMI Score

    Time frame: Through study completion, an average of 1 year

    Thrombolysis In Myocardial Infarction (TIMI) mortality risk score

Sponsors and collaborators

Lead sponsor

Tarumanagara University

Other

Collaborators

  • Cengkareng General Hospital

Registry information

Official study title

Primary Prevention With Statin and Incidence of Recurrent Myocardial Infarction and Cardiogenic Shock in Post-Acute Coronary Syndrome Patients

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2018
Registry last updated
Sep 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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