STEMI (STE-ACS)PCI-STEMINCT06871358
The Effect of Atorvastatin 80 mg on Hs-CRP/Albumin Ratio in Reducing Thrombus Burden in PCI-STEMI Patients
A study testing Atorvastatin 80mg in people with STEMI (STE-ACS) and Primary PCI for STEMI, run by Universitas Sebelas Maret at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI (STE-ACS), Primary PCI for STEMI
- What is being tested?
- Atorvastatin 80mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2024to 20 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEMI with onset less than 24 hour and undergo a Primary PCI
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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
- Being tested
- Atorvastatin 80mg, Placebo
- Keywords
- Atorvastatin, hs-CRP, Albumin, TIMI Thrombus Grade, Thrombus Burden
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 80mgDrug
Also called Loading Atorvastatin 80 mg
80 mg of Atorvastatin are loading in first medical contact (Emergency Department) before primary PCI
PlaceboDrug
Only given a loading DAPT without loading Atorvastatin 80 mg
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Active comparator | receiving 80 mg of atorvastatin in emergency department before primary PCI Receives: Drug: Atorvastatin 80mg |
| Placebo | Placebo comparator | Did not receive Atorvastatin 80 mg before Primary PCI Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 3 days
Secondary outcomes (1)
TIMI Thrombus Burden
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.
Measured: From enrollment to door to balloon time (Less than 24 hour onset)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Sep 2024
- Primary completion30 Oct 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for STEMI (STE-ACS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yos Akbar Irmansyah, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871358
- Sponsor's protocol ID
- 2.149/VIII/HREC/2024
- Other IDs
- RSUD Dr. Moewardi
- Acronym
- PCI-STEMI
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To prevent similarity in primary Data
Publications
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.
PubMed 32651772Wasyanto 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
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.
PubMed 30808220Karabag 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.
PubMed 29577260Acet 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.
PubMed 33371718Wang 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.
PubMed 32908939Salari 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.
PubMed 37087452Kadappu 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.
PubMed 36013563Waksman 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.
PubMed 38165117
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06871358
- Acronym / sponsor ID
- PCI-STEMI / 2.149/VIII/HREC/2024
- Conditions
- STEMI (STE-ACS), Primary PCI for STEMI
- Keywords
- Atorvastatin, hs-CRP, Albumin, TIMI Thrombus Grade, Thrombus Burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Active comparator | Drug: Atorvastatin 80mgreceiving 80 mg of atorvastatin in emergency department before primary PCI |
| Placebo | Placebo comparator | Drug: PlaceboDid not receive Atorvastatin 80 mg before Primary PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- STEMI with onset less than 24 hour and undergo a Primary PCI
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 80mgAlso: Loading Atorvastatin 80 mg80 mg of Atorvastatin are loading in first medical contact (Emergency Department) before primary PCI | Drug | Atorvastatin |
| PlaceboOnly given a loading DAPT without loading Atorvastatin 80 mg | Drug | Placebo |
Primary outcome
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
1 secondary outcome
TIMI Thrombus Burden
Time frame: From enrollment to door to balloon time (Less than 24 hour onset)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Background: PubMed 32651772Elserafy 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.
- BackgroundWasyanto 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: PubMed 30808220Duman 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.
- Background: PubMed 29577260Karabag 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.
- Background: PubMed 33371718Acet 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.
- Background: PubMed 32908939Wang 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.
- Background: PubMed 37087452Salari 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.
- Background: PubMed 36013563Kadappu 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.
- Background: PubMed 38165117Waksman 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.
- Individual participant dataSharing planned: No. To prevent similarity in primary Data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin 80mg in people with STEMI (STE-ACS) and Primary PCI for STEMI, run by Universitas Sebelas Maret at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hs-CRP/Albumin ratio (time frame: From enrollment to the end of treatment at 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06871358, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.