CTRI/2022/07/044378招募中3 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)
ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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
入选标准
- •Written informed consent must be obtained before any assessment is performed.
- •-Male or female greater than or equal to 18 years or less than or equal to 80 years of age at signing of informed consent.
- •-Fasting LDL-C local lab value at the Screening Visit of either i) greater than or equal to 100 mg/dL if on statin therapy but not on a maximally tolerated statin therapy; ii) greater than or equal to 150 mg/dL if statin naive and without documented statin intolerance; or iii) greater than or equal to 70 mg/dL if on a stable (greater than or equal to 4 weeks) dose of maximally tolerated statin therapy or if statin intolerant.
- •-Participants may be pre-identified based on a CCTA or an invasive angiography that is performed as part of standard of care within 12 months prior to the participants Screening Visit demonstrating:
- •--Presence of coronary artery plaque with visual diameter stenosis less than 50 percent or
- •--Coronary artery plaque with visual artery stenosis greater than 50 percent but Fractional Flow Reserve (FFR) greater than 0.8 by special wire measurement (CCTA or coronary angiography)
- •-Fasting LDL-C local lab value greater than or equal to 70 mg/dL at the assessment performed during the Statin Optimization Period 3 Visit for participants going through the Statin Optimization Period.
- •-Participants having Non-Obstructive Coronary Artery (NOCA) confirmed by CCTA with FFRCT greater than 0.8 and CT-adapted Leaman score greater than 5 or coronary artery plaque with visual diameter stenosis greater than 50 percent but with FFRCT greater than 0.8 and CT-adapted Leaman score greater than 5 without previous cardiovascular events.
- •-At the Baseline Visit, participants must be on a stable (greater than or equal to 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.
排除标准
- •-Previous myocardial infarction (MI), or prior coronary revascularization [percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)].
- •-Planned revascularization (PCI or CABG).
- •-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.
- •-History of Peripheral Artery Disease (PAD):
- •--Prior documentation of a resting ankle-brachial index less than 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.
- •-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.
- •-NOCA participant who was prescreened by the Investigator with visual diameter stenosis >50% but FFR less than 0.8.
- •-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.
- •-Pacemaker or implantable cardioverter-defibrillator (ICD) in situ.
- •-Systolic Left Ventricle Ejection Fraction less than 30 percent at the Screening Visit.
- •-Uncontrolled severe hypertension: systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg prior to randomization (assessed at the Screening Visit) despite antihypertensive therapy.
- •-Heart failure New York Heart Association (NYHA) class III or class IV at the Screening Visit.
- •-Renal insufficiency (eGFR less than 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.
- •-Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Screening Visit. Participants who enter the Statin Optimization Period must have AST and ALT less than or equal to 3x ULN (as defined by local laboratory reference ranges collected at the Screening Visit) and reported by the Statin Optimization Telephone Visit 1 to be allowed to continue in the Statin Optimization Period.
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