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

Universitas Sebelas Maret

Status: Completed

Conditions: Primary PCI for STEMI; STEMI (STE-ACS)

Treatments: Drug: Placebo; Drug: Atorvastatin 80mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06871358

2.149/VIII/HREC/2024

RSUD Dr. Moewardi (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups, including a placebo group

Atorvastatin

Active Comparator group

Description:

receiving 80 mg of atorvastatin in emergency department before primary PCI

Treatment:

Drug: Atorvastatin 80mg

Placebo

Placebo Comparator group

Description:

Did not receive Atorvastatin 80 mg before Primary PCI

Treatment:

Drug: Placebo