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

NCT ID: NCT06871358

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2024-11-20

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

Conditions

STEMI (STE-ACS); Primary PCI for STEMI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Atorvastatin

receiving 80 mg of atorvastatin in emergency department before primary PCI

Group Type: ACTIVE_COMPARATOR

Atorvastatin 80mg

Intervention Type: DRUG

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

Placebo

Did not receive Atorvastatin 80 mg before Primary PCI

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Only given a loading DAPT without loading Atorvastatin 80 mg

Interventions

Atorvastatin 80mg

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

Intervention Type: DRUG

Placebo

Only given a loading DAPT without loading Atorvastatin 80 mg

Intervention Type: DRUG

Other Intervention Names

Loading Atorvastatin 80 mg

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitas Sebelas Maret

OTHER

Sponsor Role: lead

Responsible Party

Yos Akbar Irmansyah

Senior Cardiology Resident, Cardiology Department of Medical Faculty of Universitas Sebelas Maret

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

RSUD Dr Moewardi

Surakarta, Central Java, Indonesia

Countries

Indonesia

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Other Identifiers

RSUD Dr. Moewardi

Identifier Type: OTHER

Identifier Source: secondary_id

2.149/VIII/HREC/2024

Identifier Type: -

Identifier Source: org_study_id