Clinical Trials List
2020-11-30 - 2027-12-31
Phase III
Recruiting1
Terminated5
ICD-10I25.10
Atherosclerotic heart disease of native coronary artery without angina pectoris
ICD-9429.2
Cardiovascular disease, unspecified
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Inclisiran in Asian Patients With ASCVD or ASCVD High Risk and Elevated Low-density Lipoprotein Cholesterol as an Adjunct to Diet and Maximally Tolerated Statins With or Without Additional Lipid-lowering Therapy (ORION-18)
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 陳盈憲 Division of General Internal Medicine
- 林柏志 Division of General Internal Medicine
- HUNG-JU LIN Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chern-En Chiang Division of Cardiovascular Diseases
- 吳承學 Division of Cardiovascular Diseases
- Shih-Hsien Sung Division of Cardiovascular Diseases
- Wen-Chung Yu Division of Cardiovascular Diseases
- 黃少嵩 Division of Cardiovascular Diseases
- Tse-Min Lu Division of Cardiovascular Diseases
- Hao-min Cheng Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Ye-Hsu Lu Division of Cardiovascular Diseases
- 蔡子賢 未分科
- 黃天祈 Division of Cardiovascular Diseases
- 吳韋璁 Division of Cardiovascular Diseases
- Cheng-An Chiu Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
- Po-Chao Hsu Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Superiority of inclisiran compared to placebo in reducing LDL-C from baseline to Day 330
Extension: Number of participants with Adverse Events [ Time Frame: Day 360 until study completion, an average of 3 years ]
Evaluation of the safety and tolerability of inclisiran, treatment emergent Adverse events and Serious Adverse Events
Inclution Criteria
-At screening participants with: ASCVD (including acute coronary syndrome (ACS), stable coronary heart disease, post revascularization, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack (TIA), and peripheral atherosclerosis) and Serum LDL-C ≥1.8 mmol/L (≥70 mg/dL) OR ASCVD high risk (LDL-C ≥4.9 mmol/L, diabetes, high 10-year ASCVD risk assessed by Chinese ASCVD Risk Assessment Flow Chart , or high risk per local guidelines with a target LDL-C of <100 mg/dL) and Serum LDL-C ≥2.6 mmol/L (≥100 mg/dL)
Fasting triglyceride < 400 mg/dL (< 4.52 mmol/L) at screening.
Participants on statins should be receiving a maximally tolerated dose . Maximum tolerated dose is defined as the maximum dose of statin that can be taken on a regular basis without intolerable AE. Intolerance to any dose of statin must be documented as historical AEs attributed to the statin in question on the source documentation and on the Medical history page of the eCRF
Participants not receiving statin must have a documented evidence of intolerance to all doses of at least 2 different statins(or the corresponding local definition of complete intolerance to statins)
Participants following lifestyle modification should be on the therapy of LDL-C lowering (such as statin monotherapy, or statin incombination with ezetimibe) with a stable dose for ≥30 days before screening and have no planned medication or dose change during study participation.
Participants are willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures.
Exclusion Criteria
New York Heart Association (NYHA) class IV heart failure or last known left ventricular ejection fraction <25%.
Cardiac arrhythmia with clinical significance within 3 months prior to randomization that is not controlled by medication or via ablation.
Major adverse cardiovascular event within 3 months prior to randomization.
Uncontrolled severe hypertension: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg prior to randomization despite antihypertensive therapy.
Calculated glomerular filtration rate ≤30 mL/min by estimated glomerular filtration rate (eGFR) using standardized clinical methodology.
Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.
History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the three years prior to randomization.
Barrier method: Condom or Occlusive cap (e.g. diaphragm or cervical/vault caps).
Other protocol-defined inclusion/exclusion criteria may apply.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
320 participants
