Acute Coronary SyndromesNCT07008794
Effect of Genetic Variation on Efficacy and Safety of Lipid-Lowering Drugs
An observational study of Acute Coronary Syndromes, run by Assiut University at 1 site in Egypt.
Trial summary
The primary end point was to reduce LDL-C levels by at least 50%, while the secondary end point was to achieve an LDL-C level below 55 mg/dL. The incidence and specifics of side effects and laboratory abnormalities were recorded throughout the follow-up period to evaluate safeguarding. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- Atorvastatin 40 mg
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 31 Mar 2023
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Initially, the study collected patient information, including smoking status, age, BMI, and sex. Furthermore, concurrent medication use, comorbidities, and a detailed medical history were collected. Standard laboratory tests included baseline measurements of HbA1c, blood urea nitrogen, serum creatinine, and whole blood picture. While the following parameters at baseline and after 12 weeks were evaluated: CK, HBA1c, TG, HDL, VLDL-C, and LDL-C. Liver function tests included AST and ALT levels.
Who may be able to join
- Patients aged exceeding 18 years,
- Those with ACS confirmation, and those who had not started statin medication during the last 2 months were included
Who cannot join
- Patients using bile acid sequestrants (colesevelam, cholestyramine), fenofibrate, ezetimibe, niacin, and/or omega-3, as well as those taking concurrently interacting medications (cyclosporine, gemfibrozil, clarithromycin, and/or itraconazole), were excluded from consideration
- During the recruitment process, the study excluded women who were pregnant, nursing, or of childbearing age without a reliable method of contraception.
- As well as patients with bile duct issues, active liver disease, elevated ALT levels exceeding three times the upper normal limit (UNL), serum creatinine levels above 2 mg/dL,
- Individuals who had undergone or reported a hypersensitivity reaction to any currently used statins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studying the Effect of Genetic Variation on Efficacy and Safety of Lipid-Lowering Drugs in Patients With Cardiovascular Diseases
The primary end point was to reduce LDL-C levels by at least 50%, while the secondary end point was to achieve an LDL-C level below 55 mg/dL. The incidence and specifics of side effects and laboratory abnormalities were recorded throughout the follow-up period to evaluate safeguarding. Liver function tests were performed at baseline and 12 weeks later. Any muscle-related complaints were noted at baseline and during the 12-week sessions. CK total and Hba1c were also assessed
Read the detailed description
CVD are the world's leading cause of death. Egypt has the largest population among the MENA countries, ranks the 2nd in the region for CVD, accounting for 268.11 deaths, or 32.40% of all deaths. Egypt is also ranked 15th globally for cardiovascular mortality.
The total economic costs from non-communicable illnesses in low- and middle-income countries (LMICs) are anticipated to surpass $7 trillion, representing approximately 4% of their annual output. An estimated $25 billion yearly might be saved by a 10% decrease in mortality from IHD greatly paying the expenses of preventative programs The 2019 and 2023 ESC guidelines state that individuals with ACS should aim for a target LDL-C level of < 55 mg/dL (less than 1.4 mmol/L) and achieve a decrease in LDL-C of at least 50% from the initial level
High-intensity statin regimens are medications that decrease LDL-C concentrations by a minimum of 50% . Some examples of high-intensity regimens include rosuvastatin administered at a dose of 20-40 mg and atorvastatin administered at a dose of 40-80.
Statins have been proven to be safe and well-tolerated in managing ACS. However, high-dose statins occasionally resulted in increased in liver transaminases, particularly ALT, and an elevated frequency of ADR. In addition, the muscular symptoms associated with statin use include clinical rhabdomyolysis and myalgia .
Comparing the effects of high-intensity statins in patients who are globalized after ACS, a topic of numerous investigations recently, rosuvastatin appears to decrease LDL-C levels more effectively than atorvastatin. However, no clinical studies have investigated this issue at Assiut University Heart Hospital. Consequently, this investigation aimed to evaluate the effectiveness and safety of atorvastatin 40 mg and rosuvastatin 20 mg in Egyptian patients who had experienced ACS.
- Conditions
- Acute Coronary Syndromes
- Being tested
- Atorvastatin 40 mg
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 40 mgDrug
Rosuvastatin 20 mg
| Study group | Role | What they receive |
|---|---|---|
| The first group=atorvastatin on 40 mg/day, | The first group=atorvastatin on 40 mg/day, the second group = rosuvastatin 20 mg.
all groups received standard therapy included dual antiplatelets ,ACEIs, beta blockers. Receives: Drug: Atorvastatin 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was achieving ≥ 50% LDL-C (mg/dL) reduction from the baseline.
Group 1; administrate atorvastatin 40 mg while the second group administrated rosuvastatin 20 mg.
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Target level
To achieve attainment of LDL-C level < 55 mg/dL from baseline
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Apr 2022
- Primary completion30 Nov 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayad Ali Ahmed Abdullah, Assiut University
- Investigators
- Hosam Ali Mohamed, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008794
- Sponsor's protocol ID
- Statin in cardiovascular
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
WHO. Global causes of deaths. 2021.
Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J Acute Cardiovasc Care. 2024 Feb 9;13(1):55-161. doi: 10.1093/ehjacc/zuad107. No abstract available.
PubMed 37740496Rao SV, O'Donoghue ML, Ruel M, Rab T, Tamis-Holland JE, Alexander JH, Baber U, Baker H, Cohen MG, Cruz-Ruiz M, Davis LL, de Lemos JA, DeWald TA, Elgendy IY, Feldman DN, Goyal A, Isiadinso I, Menon V, Morrow DA, Mukherjee D, Platz E, Promes SB, Sandner S, Sandoval Y, Schunder R, Shah B, Stopyra JP, Talbot AW, Taub PR, Williams MS. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Apr;151(13):e771-e862. doi: 10.1161/CIR.0000000000001309. Epub 2025 Feb 27.
PubMed 40014670
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Effect of Genetic Variation on Efficacy and Safety of Lipid-Lowering Drugs in Patients With Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT07008794
- Acronym / sponsor ID
- Statin in cardiovascular
- Conditions
- Acute Coronary Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 6 Jun 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.
The primary end point was to reduce LDL-C levels by at least 50%, while the secondary end point was to achieve an LDL-C level below 55 mg/dL. The incidence and specifics of side effects and laboratory abnormalities were recorded throughout the follow-up period to evaluate safeguarding. Liver function tests were performed at baseline and 12 weeks later. Any muscle-related complaints were noted at baseline and during the 12-week sessions. CK total and Hba1c were also assessed
Detailed description
CVD are the world's leading cause of death. Egypt has the largest population among the MENA countries, ranks the 2nd in the region for CVD, accounting for 268.11 deaths, or 32.40% of all deaths. Egypt is also ranked 15th globally for cardiovascular mortality.
The total economic costs from non-communicable illnesses in low- and middle-income countries (LMICs) are anticipated to surpass $7 trillion, representing approximately 4% of their annual output. An estimated $25 billion yearly might be saved by a 10% decrease in mortality from IHD greatly paying the expenses of preventative programs The 2019 and 2023 ESC guidelines state that individuals with ACS should aim for a target LDL-C level of < 55 mg/dL (less than 1.4 mmol/L) and achieve a decrease in LDL-C of at least 50% from the initial level
High-intensity statin regimens are medications that decrease LDL-C concentrations by a minimum of 50% . Some examples of high-intensity regimens include rosuvastatin administered at a dose of 20-40 mg and atorvastatin administered at a dose of 40-80.
Statins have been proven to be safe and well-tolerated in managing ACS. However, high-dose statins occasionally resulted in increased in liver transaminases, particularly ALT, and an elevated frequency of ADR. In addition, the muscular symptoms associated with statin use include clinical rhabdomyolysis and myalgia .
Comparing the effects of high-intensity statins in patients who are globalized after ACS, a topic of numerous investigations recently, rosuvastatin appears to decrease LDL-C levels more effectively than atorvastatin. However, no clinical studies have investigated this issue at Assiut University Heart Hospital. Consequently, this investigation aimed to evaluate the effectiveness and safety of atorvastatin 40 mg and rosuvastatin 20 mg in Egyptian patients who had experienced ACS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The first group=atorvastatin on 40 mg/day, | – | Drug: Atorvastatin 40 mgThe first group=atorvastatin on 40 mg/day, the second group = rosuvastatin 20 mg. all groups received standard therapy included dual antiplatelets ,ACEIs, beta blockers. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Initially, the study collected patient information, including smoking status, age, BMI, and sex. Furthermore, concurrent medication use, comorbidities, and a detailed medical history were collected. Standard laboratory tests included baseline measurements of HbA1c, blood urea nitrogen, serum creatinine, and whole blood picture. While the following parameters at baseline and after 12 weeks were evaluated: CK, HBA1c, TG, HDL, VLDL-C, and LDL-C. Liver function tests included AST and ALT levels.
Key inclusion criteria (2 listed)
- Patients aged exceeding 18 years,
- Those with ACS confirmation, and those who had not started statin medication during the last 2 months were included
Key exclusion criteria (4 listed)
- Patients using bile acid sequestrants (colesevelam, cholestyramine), fenofibrate, ezetimibe, niacin, and/or omega-3, as well as those taking concurrently interacting medications (cyclosporine, gemfibrozil, clarithromycin, and/or itraconazole), were excluded from consideration
- During the recruitment process, the study excluded women who were pregnant, nursing, or of childbearing age without a reliable method of contraception.
- As well as patients with bile duct issues, active liver disease, elevated ALT levels exceeding three times the upper normal limit (UNL), serum creatinine levels above 2 mg/dL,
- Individuals who had undergone or reported a hypersensitivity reaction to any currently used statins
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 40 mgRosuvastatin 20 mg | Drug | The first group=atorvastatin on 40 mg/day, |
Primary outcome
The primary outcome was achieving ≥ 50% LDL-C (mg/dL) reduction from the baseline.
Time frame: Baseline and 12 weeks
Group 1; administrate atorvastatin 40 mg while the second group administrated rosuvastatin 20 mg.
1 secondary outcome
Target level
Time frame: Baseline and 12 weeks
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 6 Jun 2025.
- BackgroundWHO. Global causes of deaths. 2021.
- Background: PubMed 37740496Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J Acute Cardiovasc Care. 2024 Feb 9;13(1):55-161. doi: 10.1093/ehjacc/zuad107. No abstract available.
- Results publication: PubMed 40014670Rao SV, O'Donoghue ML, Ruel M, Rab T, Tamis-Holland JE, Alexander JH, Baber U, Baker H, Cohen MG, Cruz-Ruiz M, Davis LL, de Lemos JA, DeWald TA, Elgendy IY, Feldman DN, Goyal A, Isiadinso I, Menon V, Morrow DA, Mukherjee D, Platz E, Promes SB, Sandner S, Sandoval Y, Schunder R, Shah B, Stopyra JP, Talbot AW, Taub PR, Williams MS. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Apr;151(13):e771-e862. doi: 10.1161/CIR.0000000000001309. Epub 2025 Feb 27.
- Individual participant dataSharing planned: No
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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.
Hosam Ali Mohamed, Professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes, run by Assiut University at 1 site in Egypt.
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 2 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 6 Jun 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 Egypt. 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. 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?
The primary outcome was achieving ≥ 50% LDL-C (mg/dL) reduction from the baseline. (time frame: Baseline and 12 weeks). 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 NCT07008794, which also lists 3 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 6 Jun 2025.