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Evaluating the effect of treatment with Evolocumab on lipoproteins levels in patients with atherosclerotic cardiovascular diseases resistant to treatment with anti-lipid drugs with high levels of LDL-C

Evaluating the effect of treatment with Evolocumab on lipoproteins levels in patients with atherosclerotic cardiovascular diseases resistant to treatment with anti-lipid drugs with high levels of LDL-C

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230309057664N1
Enrollment
54
Registered
2024-11-26
Start date
2024-12-21
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Dyslipidemia.

Interventions

Intervention 1: Intervention group: They will receive standard treatment measures to correct dyslipidemia, which include statins, plus a 140mg dose of Evolocumab with brand name of Repatha as a subcut

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: People with history of cardiovascular diseases including ST Elevation Myocardial Infarction (STEMI), non STEMI, history of Percoutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG) fasting LDL-C equal more than 70mg/dl Age between 18 and 80 under treatment with high dose Astatins ( Atorvastatin dosage 20-40 mg or Rosuvastatnin dosage 20-40 mg) Having consent

Exclusion criteria

Exclusion criteria: History of hemorrhagic stroke Past drug history of using PCSK9 inhibitors Glumerular filtering rate (GFR) < 30% Past medical history of malignancies History of major organ transplant Pastmedical history or family history of hereditory myogenic disorders Pregnancy or breastfeeding or deciding to get pregnant Allergy to Evolocumab, not tolerating it or causing complications in the patients Patient's unwillingness to participate in the study, cooperate, or take medication correctly

Design outcomes

Primary

MeasureTime frame
Changes in lipid profile including Total cholesterol, TG, LDL-C, HDL-C, and LDL-C/HDL-C ratio and their achievement to target levels. Timepoint: In this study, the patient's lipid profile will be examined by tests at the beginning of the study and 12 weeks after beginning ovolacumab administeration. Method of measurement: Performing biochemical tests on the patient's blood sample.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNegin Vejdani Nozar

Hamedan University of Medical Sciences

negin.v1999@gmail.com+98 81 3262 0828

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026