EUCTR2021-004601-47-IE进行中（未招募）1 期
A multi-center, randomized, double-blind, placebo controlled, parallel-group Phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events (VICTORION-PLAQUE) - VICTORION-PLAQUE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Written informed consent must be obtained before any assessment is
- •2. Male or female =18 to =80 years of age at signing of informed
- •3. Fasting LDL-C local lab value at the Screening Visit of either i) =100
- •mg/dL (2.6 mmol/L) if participant is on statin therapy but not on a
- •maximally tolerated statin therapy; ii) =150 mg/dL (3.9 mmol/L) if
- •participant is statin naive and without documented statin intolerance; or
- •iii) =55 mg/dL (1.4 mmol/L) if participant is on a stable (=4 weeks)
- •dose of maximally tolerated statin therapy or if statin intolerant. Local
- •laboratory values should be calculated using the Friedewald formula for
- •consistency across study sites if the Screening visit occurs prior to the
- •Baseline CCTA Visit. If the Screening and Baseline Visits occur on the same day, then the LDL-C value will be assessed on the central
- •laboratory sample. If the center can only perform the direct LDL-C test,
- •then the local lab should also obtain the total cholesterol, HDL-C, and
- •triglycerides results so that the LDL-C can be calculated using the
- •Friedewald estimation.
- •4.Fasting LDL-C local lab value =55 mg/dL (1.4 mmol/L) at the
- •assessment performed during the Statin Optimization Period 3 Visit for
- •participants going through the Statin Optimization Period. Local
- •laboratory values should be calculated using the Friedewald formula for
- •consistency across study sites. If the center can only perform the direct
- •LDL-C test, then the local lab should also obtain the total cholesterol,
- •HDL-C, and triglycerides results so that the LDL-C can be calculated
- •using the Friedewald estimation.
- •5. Participants having Non-Obstructive Coronary Artery (NOCAD)*
- •without previous cardiovascular events: NOCAD is defined as:
- •(1) Participants with a CT-adapted Leaman score >5 and a diameter
- •stenosis <50%***
- •(2) Participants with a CT-adapted Leaman score >5 and a diameter
- •stenosis =50%*but with FFRCT =0.76**. Notes: *=In case of left main
- •CAD, diameter stenosis is =40%. **=In case of FFRCT between =0.76
- •and 0.80, participant eligibility will be assessed and determined by the
- •Imaging Core Lab based on the location of the lesion, proximality of the
- •lesion, delta FFRCT, and diffuseness of coronary artery disease
- •FFRCT and CT-adapted Leaman score will be determined by the Imaging
- •A standard of care CCTA may serve as the study baseline CCTA scan if it
- •is performed within 3 months prior to the participant's Screening Visit
- •and meets the inclusion criteria as described above and as assessed by
- •the Imaging Core Lab.
- •6. At the Baseline Visit, participants must be on a stable (=4 weeks)
- •dose of maximally tolerated statin therapy. Participants not on
- •maximally tolerated statin therapy and who do not have documented
- •statin intolerance can be screened but must enter the study via a Statin
- •Optimization Period.
- •7.Fasting LDL-C lab value =55 mg/dL (1.4 mmol/L) at the Baseline Visit,
- •measured at the central laboratory. If the Baseline and Screening Visits
- •occur on the same day, then the LDL-C assessment will be assessed on
- •the central laboratory sample. If a participant qualifies at Screening but
- •the fasting central LDL-C value at the Baseline Visit does not meet
- •eligibility, the eligibility will be determined based on the central lab
- •8.Fasting triglycerides value <400 mg/dL (4.52 mmol/L) based on the
- 另有 4 项未显示
排除标准
- •1. Previous myocardial infarction (MI), or prior coronary revascularization [percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)].
- •2. Planned revascularization (PCI or CABG).
- •3. Previous ischemic cerebrovascular event including:
- •Prior ischemic stroke thought not to be caused by atrial fibrillation, valvular heart disease or mural thrombus.
- •History of prior percutaneous or surgical carotid artery revascularization.
- •4. History of Peripheral Artery Disease (PAD):
- •Prior documentation of a resting ankle-brachial index <0.85.
- •History of prior percutaneous or surgical revascularization of an iliac, femoral, or popliteal artery.
- •Prior non-traumatic amputation of a lower extremity due to peripheral artery disease.
- •5. Cardiac disorders, including any of the following:
- •Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, atrial fibrillation) within 3 months prior to randomization that is not controlled by medication or via ablation at the time of the Screening Visit.
- •Complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block) prior to randomization.
- •6. NOCA participant who was prescreened by the Investigator with visual diameter stenosis >50% but FFR <0.8.
- •7. Contraindication for CCTA (e.g., allergic reactions to the contrast dye) or CCTA not meeting entry standards after two attempts during the Baseline CCTA Visit as assessed by the Imaging Core Lab.
- •8. Pacemaker or implantable cardioverter-defibrillator (ICD) in situ.
- •9. Systolic Left Ventricle Ejection Fraction <30% at the Screening Visit.
- •10. Uncontrolled severe hypertension: mean systolic blood pressure >180 mmHg or mean diastolic blood pressure >110 mmHg prior to randomization (assessed at the Screening Visit) despite antihypertensive therapy.
- •11. Heart failure New York Heart Association (NYHA) class III or class IV at the Screening Visit.
- •12. Renal insufficiency (eGFR <30 mL/min/1.73m2) as measured by the Modification of Diet in Renal Disease (MDRD) formula at the Screening Visit and at the Statin Optimization 3 Visit.
- •13. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Screening Visit.
- •Participants who enter Screening or the Statin Optimization Visit must
- •have AST and ALT =3x ULN to be allowed to continue in the Screening or
- •Statin Optimization Period.
- •13.Local creatine kinase (CK) values of either, unless a more stringent
- •threshold is mandated by a local regulatory authority (e.g., =3x ULN in
- •Korea according to MFDS internal guideline):
- •CK values =5x ULN at the Screening Visit for participants on
- •maximally tolerated statin therapy or who are statin intolerant.
- •CK values =5x ULN at Screening and before entering the Statin
- •Optimization Period and confirmed by repeat test within 7 days at
- •Screening or based on Investigator's judgement for participants entering
- •the Statin Optimization Period (who will be switched to or initiated on
- •the protocol-specified dose of high-intensity statin of atorvastatin =40
- •mg QD or rosuvastatin =20 mg QD during the Statin Optimization
- •14. Local CK values =5x ULN at the Statin Optimization 3 Visit unless a
- •more stringent threshold is mandated by a local regulatory authority
- •(e.g., =3x ULN in Korea according to MFDS internal guideline) and
- •monitored according to national guidelines and statin label during the
- •Statin Optimization Period.
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