Skip to content

Alirocumab effect on preventing periprocedural ischemic events in coronary heart disease patients undergoing elective coronary stenting: a multicenter randomized controlled trial

Alirocumab effect on preventing periprocedural ischemic events in coronary heart disease patients undergoing elective coronary stenting: a multicenter randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063191
Enrollment
Unknown
Registered
2022-09-01
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Coronary Heart Disease

Interventions

Alirocumab Group:Alirocumab
Control Group:None

Sponsors

The Third Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Agree to be included in the study; 2. No gender limit, patients aged over 18 years; 3. Patients with coronary heart disease who plan to receive elective coronary angiography to identify coronary artery lesions and further undergo PCI implantation of drug-eluting stents; 4. Baseline LDL-C level above 3.4mmol/L (130mg/dl); 5. Patients meet one of the following criteria of (1) and (2) +one of the following criteria of (3), (4), (5), (6), (7) and (8) : (1) The patient underwent coronary CTA or coronary angiography in the past, indicating that one or more vessels of the main branch (anterior descending branch, circumflex branch, right coronary artery) or branches (diagonal branch, OM branch, PLA branch, PDA branch) were more than 70% stenosis; (2) The patient had angina pectoris, which met at least two of the following three characteristics: retrosternal discomfort, characterized by its nature and duration; Fatigue or emotional stress can be induced; Relief within minutes after rest and/or treatment with nitrates; (3) With diabetes; (4) Suffering from high blood pressure; (5) Have hyperlipidemia, including total cholesterol >=6.2mmol/L or LDL-C>=4.1mmol/L; (6) A long history of smoking; (7) Obesity, BMI>=28kg/m^2; (8) Family history of early onset cardiovascular disease, defined as first-degree relatives with coronary heart disease < 55 years old in males and < 65 years old in females.

Exclusion criteria

Exclusion criteria: 1. Acute myocardial infarction in the last 3 months; 2. Preoperative troponin was higher than the normal value; 3. Moderate to severe liver dysfunction (ALT or AST> 2 times the upper limit of normal); 4. Severe renal impairment (creatinine clearance <30 ml/min); 5. Severe anemia (hemoglobin <60g/L); 6. Patients who do not wish to use any contraceptive measures during pregnancy, lactation and preparation for pregnancy; 7. Patients who did not want to receive aliciumab for 3 months; 8. No stent was implanted.

Design outcomes

Primary

MeasureTime frame
cardiac troponin;

Countries

China

Contacts

Public ContactLiu Jinlai

The Third Affiliated Hospital, Sun Yat-sen University

liujinl@mail.sysu.edu.cn+86 20 85252168

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026