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

NCT06871358 | Completed DMC

• 2 other identifiers: 2.149/VIII/HREC/2024RSUD Dr. Moewardi
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

STEMI (STE-ACS); Primary PCI for STEMI

Keywords

Atorvastatin; hs-CRP; Albumin; TIMI Thrombus Grade; Thrombus Burden

Outcome Measures

Primary Outcomes (1)

• hs-CRP/Albumin ratio

  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 Outcomes (1)

• TIMI Thrombus Burden

  From enrollment to door to balloon time (Less than 24 hour onset)

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

receiving 80 mg of atorvastatin in emergency department before primary PCI

Drug: Atorvastatin 80mg

Placebo

PLACEBO COMPARATOR

Did not receive Atorvastatin 80 mg before Primary PCI

Drug: Placebo

Interventions

Atorvastatin 80mg DRUG

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

Also known as: Loading Atorvastatin 80 mg

Atorvastatin

Placebo DRUG

Only given a loading DAPT without loading Atorvastatin 80 mg

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Sebelas Maret: lead

Study Sites (1)

RSUD Dr Moewardi

Surakarta, Central Java, 57126, Indonesia

Location

Related Publications (9)

• Elserafy AS, Farag NM, El Desoky AI, Eletriby KA. Effect of high-intensity statin preloading on TIMI flow in patients presenting with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Egypt Heart J. 2020 Jul 10;72(1):40. doi: 10.1186/s43044-020-00074-0.

  PMID: 32651772 BACKGROUND

• Wasyanto T, Yasa A, Murti B. The Effect of Colchicine Administration on HsCRP Level and Mean Platelet Volume in Patients with Miocard Acute Infark. Indonesian Journal of Medicine. 2018 Jan 1;3(3):162-7

  BACKGROUND

• Duman H, Cinier G, Bakirci EM, Duman H, Simsek Z, Hamur H, Degirmenci H, Emlek N. Relationship Between C-Reactive Protein to Albumin Ratio and Thrombus Burden in Patients With Acute Coronary Syndrome. Clin Appl Thromb Hemost. 2019 Jan-Dec;25:1076029618824418. doi: 10.1177/1076029618824418.

  PMID: 30808220 BACKGROUND

• Karabag Y, Cagdas M, Rencuzogullari I, Karakoyun S, Artac I, Ilis D, Yesin M, Cagdas OS, Altintas B, Burak C, Tanboga HI. Usefulness of The C-Reactive Protein/Albumin Ratio for Predicting No-Reflow in ST-elevation myocardial infarction treated with primary percutaneous coronary intervention. Eur J Clin Invest. 2018 Jun;48(6):e12928. doi: 10.1111/eci.12928. Epub 2018 Apr 17.

  PMID: 29577260 BACKGROUND

• Acet H, Guzel T, Aslan B, Isik MA, Ertas F, Catalkaya S. Predictive Value of C-Reactive Protein to Albumin Ratio in ST-Segment Elevation Myocardial Infarction Patients Treated With Primary Percutaneous Coronary Intervention. Angiology. 2021 Mar;72(3):244-251. doi: 10.1177/0003319720963697. Epub 2020 Dec 29.

  PMID: 33371718 BACKGROUND

• Wang H, Liu Z, Shao J, Lin L, Jiang M, Wang L, Lu X, Zhang H, Chen Y, Zhang R. Immune and Inflammation in Acute Coronary Syndrome: Molecular Mechanisms and Therapeutic Implications. J Immunol Res. 2020 Aug 18;2020:4904217. doi: 10.1155/2020/4904217. eCollection 2020.

  PMID: 32908939 BACKGROUND

• Salari N, Morddarvanjoghi F, Abdolmaleki A, Rasoulpoor S, Khaleghi AA, Hezarkhani LA, Shohaimi S, Mohammadi M. The global prevalence of myocardial infarction: a systematic review and meta-analysis. BMC Cardiovasc Disord. 2023 Apr 22;23(1):206. doi: 10.1186/s12872-023-03231-w.

  PMID: 37087452 BACKGROUND

• Kadappu P, Jonnagaddala J, Liaw ST, Cochran BJ, Rye KA, Ong KL. Statin Prescription Patterns and Associations with Subclinical Inflammation. Medicina (Kaunas). 2022 Aug 14;58(8):1096. doi: 10.3390/medicina58081096.

  PMID: 36013563 BACKGROUND

• Waksman R, Merdler I, Case BC, Waksman O, Porto I. Targeting inflammation in atherosclerosis: overview, strategy and directions. EuroIntervention. 2024 Jan 1;20(1):32-44. doi: 10.4244/EIJ-D-23-00606.

  PMID: 38165117 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Cardiology Resident, Cardiology Department of Medical Faculty of Universitas Sebelas Maret

Model Details: 40 STEMI patients undergoing primary PCI at Dr. Moewardi General Hospital participated in this experimental investigation. Using a double-blind technique, subjects were randomized into two groups: one receiving 80 mg of atorvastatin and the other's don't. Prior to and following primary PCI, levels of albumin and hs-CRP were assessed also their correlation with TIMI Thrombus Grade.

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 11, 2025
• Study Start: September 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: November 20, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)