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Completed

NCT Number: NCT06871358

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RSUD Dr Moewardi

Surakarta, Central Java, 57126, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Atorvastatin 80mg

Drug

80 mg of Atorvastatin are loading in first medical contact (Emergency Department) before primary PCI

Other names: Loading Atorvastatin 80 mg

Placebo

Drug

Only given a loading DAPT without loading Atorvastatin 80 mg

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universitas Sebelas Maret

Other

Registry information

Official study title

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

Acronym: PCI-STEMI

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

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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