Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Khyber Teaching Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate-Intensity Statins | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months after the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Myopathy | The number of participants who develop myopathy as an adverse effect of statins, determined through clinical symptoms and laboratory tests. | Throughout the 3-month treatment duration |
| Frequency of Elevated Liver Enzymes |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid Profile Changes During Follow-Up | Changes in LDL-C levels as measured through laboratory investigations at 1 month and 3 months. Unit of Measure: LDL-C levels (mg/dL) | 1 month and 3 months |
| Liver Function Test (LFT) Results During Follow-Up |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr Shafeeq Mehmood, MBBS | Khyber Teaching Hospital | Principal Investigator |
| Muhammad Faheem Mehmood, MBBS | Khyber Teaching Hospital | Principal Investigator |
| Syed Muhammad Shabbir Ali Naqvi | Clinical Trial Unit, Khyber Medical University Peshawar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MTI-KTH (Medical Teaching Institution-Khyber Teaching Hospital), Peshawar-Pakistan | Peshawar | Khyber Pakhtunkhwa | 25000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23736519 | Background | 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. | |
| 15007110 | Background | Cannon 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. |
Not provided
Not provided
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.
The data will be made available starting six months after the publication of the study results and will remain accessible for a period of five years.
Access to the data will be granted upon approval of a written proposal outlining the purpose of the data request and intended use. Researchers must provide a signed data access agreement to ensure data confidentiality and compliance with ethical standards.
Not provided
Not provided
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Patients are allocated into two groups by blocked randomization (6 blocks ensuring balanced allocation).
Not provided
Not provided
Randomized (Blocked randomization)
Not provided
|
| High-Intensity Statins | Drug | 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. |
|
|
The number of participants with elevated liver enzyme levels (AST and ALT) as an adverse effect of statin therapy, determined through laboratory tests.
| 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. | 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. | 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. | 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:
| Baseline and at 3 months |
Changes in liver enzyme levels (AST and ALT) as measured through laboratory investigations at 1 month and 3 months.
Unit of Measure:
LFT levels (U/L)
| 1 month and 3 months |
| Creatine Phosphokinase (CPK) Levels During Follow-Up | Changes in CPK levels as measured through laboratory investigations at 1 month and 3 months. Unit of Measure: CPK levels (U/L) | 1 month and 3 months |
| 15755765 | Background | LaRosa 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. |
| 21067804 | Background | Cholesterol 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. |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |