Comparing high and moderate intensity statins for lowering cholesterol after heart issues
Comparison of High and Moderate Intensity Statins in Achieving the Target LDL-C Level After Acute Coronary Syndrome: Randomized Controlled Trial
This study is testing whether moderate-intensity statins can lower cholesterol just as well as high-intensity statins for people who have had heart issues, while also looking at the side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 25 Years to 85 Years |
| Sex | All |
| Sponsor | Khyber Medical University Peshawar Academic / other |
| Locations | 1 site (Peshawar, Khyber Pakhtunkhwa) |
| Trial ID | NCT06782243 on ClinicalTrials.gov |
What this trial studies
This study evaluates how effective high-intensity statins are compared to moderate-intensity statins in achieving target low-density lipoprotein cholesterol (LDL-C) levels in patients who have experienced acute coronary syndrome (ACS). It aims to determine if moderate-intensity statins can provide similar benefits while reducing the risk of adverse effects associated with higher doses. Participants will be randomly assigned to receive either type of statin, and the primary outcome will be the percentage of participants achieving a significant reduction in LDL-C after three months. Secondary outcomes will assess the frequency of side effects and changes in liver function tests and muscle enzyme levels.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25 to 85 diagnosed with acute coronary syndrome.
Not a fit: Patients with a history of adverse reactions to statins or current acute liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify safer and equally effective cholesterol-lowering treatments for patients with acute coronary syndrome.
How similar studies have performed: Other studies have suggested that moderate-intensity statins can be effective, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants aged between 25 and 85 years. * Both males and females. * Diagnosed with acute coronary syndrome as defined in the operational definitions. Exclusion Criteria: * 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
Where this trial is running
Peshawar, Khyber Pakhtunkhwa
- MTI-KTH (Medical Teaching Institution-Khyber Teaching Hospital), Peshawar-Pakistan — Peshawar, Khyber Pakhtunkhwa, Pakistan (Recruiting)
Study contacts
- Principal investigator: Dr Shafeeq Mehmood, MBBS — Khyber Teaching Hospital
- Study coordinator: Dr Shafeeq Mehmood, MBBS
- Email: shafeeqmehmood001@gmail.com
- Phone: +92 315 9576362
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.