Evaluating the effect of active immunotherapy against PCSK9 on LDL-C level

Evaluating the effect of active immunotherapy against PCSK9 on LDL-C level in patients with ischemic heart disease

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130829014521N24

Enrollment

Registered

2025-09-19

Start date

2025-10-07

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Ischemic heart disease. Ischaemic heart diseases

Interventions

Intervention 1: Intervention group: Active immunotherapy against PCSK9 (by subcutaneous injection) every two weeks at baseline, week 2, 4, and 6. Intervention 2: Control group: Subcutaneous normal sal

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Consent to participate in the study Living in Mashhad Aged 18 or older Approved ischemic heart disease Failing to achieve the LDL-C therapeutic targets despite taking statins or ezetimibe or failing to achieve the LDL-C therapeutic targets due to contraindications for statins or ezetimibe

Exclusion criteria

Exclusion criteria: History of autoimmune or severe allergic diseases Under treatment with immunomodulatory drugs Under treatment with PCSK9 inhibitors such as Evolocumab or Alirocumab

Design outcomes

Primary

Measure	Time frame
Lipid profile (total cholesterol, HDL-C, LDL-C, Triglyceride, VLDL, LP(a), apo (B)). Timepoint: LDL at baseline, week 2, week 4, week 6, week 8. Other lipid profiles only at baseline and week 8. Method of measurement: Blood test.;Serum level of PCSK9. Timepoint: baseline, week 2, week 4, week 6, week 8. Method of measurement: Blood test.	—

Secondary

Measure	Time frame
High-sensitivity C-reactive protein (hs-CRP). Timepoint: Baseline, 8 week. Method of measurement: Blood test.;Liver enzymes (including alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP)). Timepoint: Baseline, 8 week. Method of measurement: Blood test.;Complete Blood Count (CBC). Timepoint: Baseline, 8 week. Method of measurement: Blood test.;Creatinine. Timepoint: Baseline, 8 week. Method of measurement: Blood test.;Blood Urea Nitrogen (BUN). Timepoint: Baseline, 8 week. Method of measurement: Blood test.	—

Measure

Time frame

High-sensitivity C-reactive protein (hs-CRP). Timepoint: Baseline, 8 week. Method of measurement: Blood test.;Liver enzymes (including alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP)). Timepoint: Baseline, 8 week. Method of measurement: Blood test.;Complete Blood Count (CBC). Timepoint: Baseline, 8 week. Method of measurement: Blood test.;Creatinine. Timepoint: Baseline, 8 week. Method of measurement: Blood test.;Blood Urea Nitrogen (BUN). Timepoint: Baseline, 8 week. Method of measurement: Blood test.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmirhossein Sahebkar

Mashhad University of Medical Sciences

sahebkara@mums.ac.ir+98 51 3180 1100

Outcome results

None listed

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