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Bempedoic Acid as Early Therapy in Combination with Statins in Hospitalized Patients with Acute Coronary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Bempedoic Acid as Early Therapy in Combination with Statins in Hospitalized Patients with Acute Coronary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251121068068N1
Enrollment
100
Registered
2026-01-31
Start date
2025-12-21
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACS (including myocardial infarction with or without ST elevation, unstable angina).

Interventions

Intervention 1: Intervention group: Intervention group: 180 mg bempedoic acid tablet daily along with high-dose atorvastatin (40-80 mg) daily from the time of acute coronary syndrome diagnosis until t

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age = 18 years Confirmed diagnosis of acute coronary syndrome LDL-C level = 70 mg/dL within the first 24 hours of patient admission Ability and willingness to provide written informed consent

Exclusion criteria

Exclusion criteria: History of hypersensitivity or allergy to bempedoic acid or statins Kidney failure with creatinine clearance less than 30 ml/min History of severe statin-related myopathy leading to discontinuation of the drug Known history of gout or hyperuricemia (uric acid > 9 mg/dl) Pregnancy or breastfeeding Presence of cardiogenic shock upon admission? Life-threatening arrhythmias Patients with a life expectancy of less than 6 months, according to the treating physician's clinical judgment History of heart surgery in the past 3 months Known severe valvular heart disease Unwillingness or inability to cooperate for follow-up visits

Design outcomes

Primary

MeasureTime frame
Comparison of achieving LDL-C levels below 55 mg/dL between the intervention and control groups at the end of the study. Timepoint: week 8. Method of measurement: Blood test.

Secondary

MeasureTime frame
Comparison of the percentage reduction in LDL-C to below 55 mg/dL. Timepoint: Baseline and during the study. Method of measurement: lab test.;Comparison of the percentage reduction and changes in LDL-C in the two intervention groups. Timepoint: In weeks 4 and 8. Method of measurement: lab test.;? Reduction in the occurrence of major cardiovascular events (MACE), including death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization. Timepoint: Over 8 weeks. Method of measurement: lab test.;Reduction of high-sensitivity C-reactive protein. Timepoint: Baseline and at 4 and 8 weeks. Method of measurement: lab test.;Troponin. Timepoint: baseline and pre-discharge. Method of measurement: lab test.;?Occurrence of drug side effects, especially muscular side effects (including cramps, myopathy), rhabdomyolysis. Timepoint: ?At 4 and 8 weeks. Method of measurement: lab test.;Uric Acid. Timepoint: ?At 4 and 8 weeks. Method of measurement: Lab test.;Liver enzymes. Timepoint: ?At 4 and 8 weeks. Method of measurement: Lab test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKeyhan Mohammadi

Tehran University of Medical Sciences

keyhanmohammadi72@yahoo.com+98 21 6658 1692

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026