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

Not Applicable

Completed

• Conditions: STEMI (STE-ACS); Primary PCI for STEMI
• Interventions: Drug: Atorvastatin 80mg; Drug: Placebo

• Registration Number: NCT06871358
• Lead Sponsor: Universitas Sebelas Maret

Brief Summary

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.

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 Timeline

• Study Start: 2024-09-01
• Primary Completion: 2024-10-30
• Study Completion: 2024-11-20
• Status Verified: 2025-03
• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin	Atorvastatin 80mg	receiving 80 mg of atorvastatin in emergency department before primary PCI
Placebo	Placebo	Did not receive Atorvastatin 80 mg before Primary PCI

Primary Outcome Measures

Name	Time	Method
hs-CRP/Albumin ratio	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 Outcome Measures

Name	Time	Method
TIMI Thrombus Burden	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.

Trial Locations

Locations (1)

RSUD Dr Moewardi; 🇮🇩 Surakarta, Jawa Tengah, Indonesia