Acute Coronary SyndromeNCT06782243
Comparison of High and Moderate Intensity Statins in Achieving the Target LDL-C Level After Acute Coronary Syndrome
A study testing Moderate-Intensity Statins and High-Intensity Statins in people with Acute Coronary Syndrome, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial summary
This study evaluates the effectiveness of high- and moderate-intensity statins in achieving target low-density lipoprotein cholesterol (LDL-C) levels in patients with acute coronary syndrome (ACS). Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Moderate-Intensity Statins and High-Intensity Statins
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Dec 2024to 25 Aug 2025
- 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged between 25 and 85 years.
- Both males and females.
- Diagnosed with acute coronary syndrome as defined in the operational definitions.
Who cannot join
- History of adverse reactions to statins (e.g., hypersensitivity, myopathy, acute renal failure).
- Current acute liver disease.
- Pregnant or breastfeeding women.
- Participants already on statin therapy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
MTI-KTH (Medical Teaching Institution-Khyber Teaching Hospital), Peshawar-Pakistan
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
Official title: Comparison of High and Moderate Intensity Statins in Achieving the Target LDL-C Level After Acute Coronary Syndrome: Randomized Controlled Trial
This study evaluates the effectiveness of high- and moderate-intensity statins in achieving target low-density lipoprotein cholesterol (LDL-C) levels in patients with acute coronary syndrome (ACS). The study aims to determine whether moderate-intensity statins can provide comparable benefits to high-intensity statins, particularly for patients at higher risk of adverse effects from higher doses. The findings may inform treatment decisions and reduce financial and clinical burdens on patients.
Read the detailed description
Statins are the cornerstone of therapy for reducing cardiovascular events in patients with atherosclerotic cardiovascular disease. Current guidelines recommend high-intensity statins for patients with ACS to lower LDL-C levels by 50% or more. However, emerging evidence suggests that the benefits of lowering LDL-C may be independent of the statin dose and type.
This randomized controlled trial investigates the effectiveness of moderate-intensity statins compared to high-intensity statins in reducing LDL-C levels among local populations. The study also explores whether moderate-intensity statins can mitigate adverse effects, such as myopathy or liver dysfunction, commonly associated with high-intensity statin therapy, particularly in populations with lower baseline LDL-C levels and high statin responsiveness.
Participants will be randomly assigned to receive either high-intensity or moderate-intensity statin therapy. The primary outcome measure is the percentage of participants achieving an LDL-C reduction of ≥50% after three months of treatment. Secondary outcomes include the frequency of adverse effects, adherence to therapy, and changes in liver function tests (LFTs) and creatine phosphokinase (CPK) levels.
The study will contribute to understanding the role of moderate-intensity statins in managing LDL-C levels and guide future clinical practices for patient subgroups at risk of adverse effects from high-intensity therapy.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Moderate-Intensity Statins, High-Intensity Statins
- Keywords
- Acute Coronary Syndrome, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Low-Density Lipoprotein Cholesterol, Cardiovascular Diseases, Drug Therapy, Combination
- Medical subject headings
- Acute Coronary Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-Intensity StatinsDrug
Also called Lipitor (brand name for Atorvastatin), Crestor (brand name for Rosuvastatin)
Participants will be administered statins based on moderate intensity. This group will receive oral tablets once daily for 3 months. The intervention includes Atorvastatin 20 mg and rosuvastatin 10 mg.
High-Intensity StatinsDrug
Also called Lipitor (brand name for Atorvastatin), Crestor (brand name for Rosuvastatin)
Participants will be administered statins based on high intensity. This group will receive oral tablets once daily for 3 months. The intervention includes Atorvastatin 40 mg and rosuvastatin 20 mg.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-Intensity Statin Group | Active comparator | Participants in this group will receive moderate-intensity statins (Atorvastatin 20 mg, Rosuvastatin 10 mg). The dosage will be in the tablet form, which will be Dosage Form: Tablet Frequency: Once daily Duration: 3 months Receives: Drug: Moderate-Intensity Statins |
| High-Intensity Statin Group | Active comparator | Participants in this group will receive high-intensity statins. Interventions include Atorvastatin 40 mg, or Rosuvastatin 20 mg which will be taken in tablet form.
Frequency: Once daily Duration: 3 months Receives: Drug: High-Intensity Statins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Low-Density Lipoprotein Cholesterol Level
The primary outcome is the percentage of participants achieving a reduction of ≥50% in LDL-C levels from baseline after 3 months of treatment with either moderate-intensity or high-intensity statins. LDL-C levels will be measured using lipid profiles obtained at baseline (upon admission) and at the end of the study (3 months post-treatment).
Measured: 3 months after the start of treatment
Secondary outcomes (6)
Frequency of Myopathy
The number of participants who develop myopathy as an adverse effect of statins, determined through clinical symptoms and laboratory tests.
Measured: Throughout the 3-month treatment duration
Frequency of Elevated Liver Enzymes
The number of participants with elevated liver enzyme levels (AST and ALT) as an adverse effect of statin therapy, determined through laboratory tests.
Measured: Throughout the 3-month treatment duration
Frequency of Elevated Creatine Phosphokinase (CPK) Levels
The number of participants with elevated CPK levels as an adverse effect of statin therapy, determined through laboratory tests.
Measured: Throughout the 3-month
Severity of Adverse Effects
The severity of adverse effects, such as myopathy, elevated liver enzymes, and elevated CPK levels, categorized using predefined clinical severity scales.
Measured: Throughout the 3-month treatment duration
Compliance with Statin Therapy
Evaluation of participant adherence to prescribed statin therapy, defined as the proportion of days with medication taken as prescribed over the 3-month period. Compliance will be assessed through patient questionnaires and medication logs.
Measured: At 3 months
Reduction in Symptom Severity
Reduction in the severity and frequency of symptoms, such as chest pain and fatigue, associated with acute coronary syndrome (ACS). Symptom severity will be measured using the Visual Analogue Scale (VAS) and patient-reported questionnaires.
VAS scores for symptom severity:
- 1-3 Mild pain
- 2-6 Moderate pain
- 7-10 Severe pain
Measured: Baseline and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start20 Dec 2024
- Primary completion30 Jul 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are allocated into two groups by blocked randomization (6 blocks ensuring balanced allocation).
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Collaborators
- Khyber Teaching Hospital
- Responsible party
- Sponsor
- Investigators
- Dr Shafeeq Mehmood, MBBS, Principal investigator, Khyber Teaching HospitalMuhammad Faheem Mehmood, MBBS, Principal investigator, Khyber Teaching HospitalSyed Muhammad Shabbir Ali Naqvi, Principal investigator, Clinical Trial Unit, Khyber Medical University Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782243
- Sponsor's protocol ID
- KMU/DIR/CTU/2024/013
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) collected during the study will be made available to other researchers upon reasonable request. The shared data will include de-identified participant data such as baseline demographic details, laboratory results, and follow-up outcomes related to LDL-C levels.
Publications
Reiner Z. Statins in the primary prevention of cardiovascular disease. Nat Rev Cardiol. 2013 Aug;10(8):453-64. doi: 10.1038/nrcardio.2013.80. Epub 2013 Jun 4.
PubMed 23736519Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, Skene AM; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 Investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004 Apr 8;350(15):1495-504. doi: 10.1056/NEJMoa040583. Epub 2004 Mar 8.
PubMed 15007110LaRosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart JC, Gotto AM, Greten H, Kastelein JJ, Shepherd J, Wenger NK; Treating to New Targets (TNT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. 2005 Apr 7;352(14):1425-35. doi: 10.1056/NEJMoa050461. Epub 2005 Mar 8.
PubMed 15755765Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.
PubMed 21067804
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High and Moderate Intensity Statins in Achieving the Target LDL-C Level After Acute Coronary Syndrome: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06782243
- Acronym / sponsor ID
- KMU/DIR/CTU/2024/013
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute Coronary Syndrome, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Low-Density Lipoprotein Cholesterol, Cardiovascular Diseases, Drug Therapy, Combination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Collaborators
- Khyber Teaching Hospital
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 17 Jan 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.
This study evaluates the effectiveness of high- and moderate-intensity statins in achieving target low-density lipoprotein cholesterol (LDL-C) levels in patients with acute coronary syndrome (ACS). The study aims to determine whether moderate-intensity statins can provide comparable benefits to high-intensity statins, particularly for patients at higher risk of adverse effects from higher doses. The findings may inform treatment decisions and reduce financial and clinical burdens on patients.
Detailed description
Statins are the cornerstone of therapy for reducing cardiovascular events in patients with atherosclerotic cardiovascular disease. Current guidelines recommend high-intensity statins for patients with ACS to lower LDL-C levels by 50% or more. However, emerging evidence suggests that the benefits of lowering LDL-C may be independent of the statin dose and type.
This randomized controlled trial investigates the effectiveness of moderate-intensity statins compared to high-intensity statins in reducing LDL-C levels among local populations. The study also explores whether moderate-intensity statins can mitigate adverse effects, such as myopathy or liver dysfunction, commonly associated with high-intensity statin therapy, particularly in populations with lower baseline LDL-C levels and high statin responsiveness.
Participants will be randomly assigned to receive either high-intensity or moderate-intensity statin therapy. The primary outcome measure is the percentage of participants achieving an LDL-C reduction of ≥50% after three months of treatment. Secondary outcomes include the frequency of adverse effects, adherence to therapy, and changes in liver function tests (LFTs) and creatine phosphokinase (CPK) levels.
The study will contribute to understanding the role of moderate-intensity statins in managing LDL-C levels and guide future clinical practices for patient subgroups at risk of adverse effects from high-intensity therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are allocated into two groups by blocked randomization (6 blocks ensuring balanced allocation).
| Arm | Type | Receives |
|---|---|---|
| Moderate-Intensity Statin Group | Active comparator | Drug: Moderate-Intensity StatinsParticipants in this group will receive moderate-intensity statins (Atorvastatin 20 mg, Rosuvastatin 10 mg). The dosage will be in the tablet form, which will be Dosage Form: Tablet Frequency: Once daily Duration: 3 months |
| High-Intensity Statin Group | Active comparator | Drug: High-Intensity StatinsParticipants in this group will receive high-intensity statins. Interventions include Atorvastatin 40 mg, or Rosuvastatin 20 mg which will be taken in tablet form. Frequency: Once daily Duration: 3 months |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants aged between 25 and 85 years.
- Both males and females.
- Diagnosed with acute coronary syndrome as defined in the operational definitions.
Key exclusion criteria (4 listed)
- History of adverse reactions to statins (e.g., hypersensitivity, myopathy, acute renal failure).
- Current acute liver disease.
- Pregnant or breastfeeding women.
- Participants already on statin therapy
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 |
|---|---|---|
| Moderate-Intensity StatinsAlso: Lipitor (brand name for Atorvastatin), Crestor (brand name for Rosuvastatin)Participants will be administered statins based on moderate intensity. This group will receive oral tablets once daily for 3 months. The intervention includes Atorvastatin 20 mg and rosuvastatin 10 mg. | Drug | Moderate-Intensity Statin Group |
| High-Intensity StatinsAlso: Lipitor (brand name for Atorvastatin), Crestor (brand name for Rosuvastatin)Participants will be administered statins based on high intensity. This group will receive oral tablets once daily for 3 months. The intervention includes Atorvastatin 40 mg and rosuvastatin 20 mg. | Drug | High-Intensity Statin Group |
Primary outcome
Reduction in Low-Density Lipoprotein Cholesterol Level
Time frame: 3 months after the start of treatment
The primary outcome is the percentage of participants achieving a reduction of ≥50% in LDL-C levels from baseline after 3 months of treatment with either moderate-intensity or high-intensity statins. LDL-C levels will be measured using lipid profiles obtained at baseline (upon admission) and at the end of the study (3 months post-treatment).
6 secondary outcomes
Frequency of Myopathy
Time frame: Throughout the 3-month treatment duration
Frequency of Elevated Liver Enzymes
Time frame: Throughout the 3-month treatment duration
Frequency of Elevated Creatine Phosphokinase (CPK) Levels
Time frame: Throughout the 3-month
Severity of Adverse Effects
Time frame: Throughout the 3-month treatment duration
Compliance with Statin Therapy
Time frame: At 3 months
Reduction in Symptom Severity
Time frame: Baseline and at 3 months
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 8 Jan 2026.
- Background: PubMed 23736519Reiner Z. Statins in the primary prevention of cardiovascular disease. Nat Rev Cardiol. 2013 Aug;10(8):453-64. doi: 10.1038/nrcardio.2013.80. Epub 2013 Jun 4.
- Background: PubMed 15007110Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, Skene AM; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 Investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004 Apr 8;350(15):1495-504. doi: 10.1056/NEJMoa040583. Epub 2004 Mar 8.
- Background: PubMed 15755765LaRosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart JC, Gotto AM, Greten H, Kastelein JJ, Shepherd J, Wenger NK; Treating to New Targets (TNT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. 2005 Apr 7;352(14):1425-35. doi: 10.1056/NEJMoa050461. Epub 2005 Mar 8.
- Background: PubMed 21067804Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) collected during the study will be made available to other researchers upon reasonable request. The shared data will include de-identified participant data such as baseline demographic details, laboratory results, and follow-up outcomes related to LDL-C levels.
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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.
Dr Shafeeq Mehmood, MBBS principal investigator
Khyber Teaching Hospital
Muhammad Faheem Mehmood, MBBS principal investigator
Khyber Teaching Hospital
Syed Muhammad Shabbir Ali Naqvi principal investigator
Clinical Trial Unit, Khyber Medical University Peshawar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-Intensity Statins and High-Intensity Statins in people with Acute Coronary Syndrome, run by Khyber Medical University Peshawar at 1 site in Pakistan.
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 3 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 8 Jan 2026. 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 Pakistan. 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?
Reduction in Low-Density Lipoprotein Cholesterol Level (time frame: 3 months after the start of treatment). 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 NCT06782243, which also lists 4 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 8 Jan 2026.