The Effect of Atorvastatin 80 Mg on Hs-CRP/Albumin Ratio in Reducing Thrombus Burden in PCI-STEMI Patients (PCI-STEMI)

March 6, 2025 updated by: Yos Akbar Irmansyah, Universitas Sebelas Maret

The Effect of Pre- and Post-Administration of 80 Mg Atorvastatin on Hs-CRP/Albumin Ratio in Reducing Thrombus Burden in STEMI Patients Undergoing Primary PCI

40 STEMI patients who underwent primary PCI were subsequently allocated into two groups via a double-blind randomization method: An Atorvastatin 80 mg group and the control group.

Levels of hs-CRP and albumin were assessed for both groups upon presentation at the emergency department before to initial PCI and were re-evaluated 24 hours after primary PCI. Thrombus burden was assessed using angiography with the TIMI Thrombus grade.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study encompasses 40 STEMI patients who underwent primary PCI at Dr. Moewardi General Hospital in Central Java, Indonesia, between September and October. This study employed an experimental design with a pre-and-post technique, with participants recruited through sequential sampling. Patients were subsequently allocated into two groups via a double-blind randomization method. A treatment group was administered a loading dose of high-intensity statin (80 mg atorvastatin) upon initial presentation at the emergency department (ED), whereas the control group received no such intervention. Both cohorts received therapy in accordance with established guidelines prior to performing primary PCI.

Levels of hs-CRP and albumin were assessed for both groups upon presentation at the emergency department before to initial PCI. In the treatment group, a second 80 mg dose of atorvastatin was provided 24 hours after the original dose. Both hs-CRP and albumin levels were re-evaluated 24 hours after primary PCI in both the control and treatment cohorts.

Thrombus burden was assessed using angiography with the TIMI Thrombus grade

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Jawa Tengah
      • Surakarta, Jawa Tengah, Indonesia, 57126
        • RSUD Dr Moewardi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • STEMI with onset less than 24 hour and undergo a Primary PCI

Exclusion Criteria:

  • STEMI beyond 24 hours from the onset of chest pain
  • Prior statin therapy within the preceding 24 hours
  • Hypersensitivity to statins, pregnancy, lactation, severe inflammatory conditions including active liver dysfunction, chronic kidney disease (eGFR <30 mL/min), autoimmune disorders, malignancy, severe malnutrition, and
  • Contraindications to statin administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Atorvastatin
receiving 80 mg of atorvastatin in emergency department before primary PCI
Drug: Atorvastatin 80mg
80 mg of Atorvastatin are loading in first medical contact (Emergency Department) before primary PCI
Other Names:
  • Loading Atorvastatin 80 mg
Placebo Comparator: Placebo
Did not receive Atorvastatin 80 mg before Primary PCI
Drug: Placebo
Only given a loading DAPT without loading Atorvastatin 80 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hs-CRP/Albumin ratio
Time Frame: From enrollment to the end of treatment at 3 days
The administration of 80 mg atorvastatin significantly reducing the hs-CRP/Albumin ratio (Δ 0.35 ± 0.67; p < 0.001) if compared to the control group
From enrollment to the end of treatment at 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TIMI Thrombus Burden
Time Frame: From enrollment to door to balloon time (Less than 24 hour onset)
Using a TIMI Thrombus Burden that measure while performing PCI, we analyze that High burden thrombus was correlated with elevated of hs-CRP/Albumin ratio (r = 0.562; p = 0.012; r > 0.05; p < 0.05). So, by reducing Hs-CRP/Albumin Ratio, it appears also reducing the TIMI Thrombus burden.
From enrollment to door to balloon time (Less than 24 hour onset)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sebelas Maret

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

October 30, 2024

Study Completion (Actual)

November 20, 2024

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.149/VIII/HREC/2024
  • RSUD Dr. Moewardi (Other Identifier: Universitas Sebelas Maret)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To prevent similarity in primary Data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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