EUCTR2020-004455-32-DK进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects with Angina due to Obstructive Coronary Artery Disease - IMPROVE-Ischemia (IMB-1018972 to Improve Myocardial Response to Ischemia)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Provide written informed consent before any screening procedures.
- •2.Able and willing to comply with all study procedures and requirements.
- •3.Male or female aged =35 years at screening
- •4.History of stable angina (CCS grading I-III) or anginal equivalent
- •within 12 months prior to screening
- •5.Regular use of at least 1 anti-anginal medication for symptomatic
- •treatment of angina (e.g. ß-blocker or calcium channel blocker) for at
- •least 2 weeks prior to start of dosing of study drug and likely to remain
- •on this therapy as background anti-anginal treatment at envisaged
- •stable doses for duration of study.
- •6.Subjects on regular beta blockade must be able to safely abstain from
- •beta blockers for 48 hours prior to DSE examinations in the opinion of
- •the Investigator.
- •7.LVEF= 45% by any imaging modality.
- •8. History (e.g. within past 5 years) of obstructive CAD or stress-induced
- •myocardial ischemia documented by any of the following:
- •CT or invasive angiography demonstrating =50% diameter stenosis in
- •=1 major coronary artery OR in the setting of significant diffuse
- •Prior percutaneous coronary intervention (PCI)
- •Prior coronary artery bypass graft (CABG) surgery
- •PET myocardial perfusion imaging demonstrating MBF<2.4 mL/min/g
- •in =2 ischemic contiguous segments or involving =10.0% of the
- •myocardium(MBF must be <2.0 mL/min/g if it was obtained in the 3
- •months prior to screening)
- •Stress echo or stress CMR demonstrating =2 ischemic contiguous
- •SPECT myocardial perfusion imaging demonstrating inducible
- •perfusion defect in =2 ischemic contiguous segments
- •9. Evaluable acoustic windows during contrast-enhanced, resting
- •echocardiography
- •10. Current 15O-H20 PET perfusion imaging demonstrating inducible
- •ischemia defined as hyperemic MBF<2.0 mL/min/g in =2 ischemic
- •contiguous segments and/or involving =10% of the myocardium.
- •Patients with a hyperemic MBF of 2.0 to 2.4 mL/min/g
- •may be eligible for randomization after discussion with the Sponsor
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •1.Clinically significant LMS or proximal LAD stenosis likely to warrant
- •revascularization during the study period in the opinion of the
- •investigator
- •2.For those subjects planned for FDG-PET imaging, subjects with Type 2
- •diabetes mellitus requiring regular insulin or diabetes that is suboptimally
- •controlled (i.e. HbA1c > 8% or 64 mmol/l)
- •3.Subjects with Type 1 insulin dependent diabetes mellitus (IDDM)
- •4.Known allergy/intolerance/absolute contra-indication to trimetazidine
- •(TMZ), adenosine, dobutamine or atropine (e.g. glaucoma),
- •echocardiography contrast agent, or excipients of the IMP.
- •5.If any of the following have occurred:
- •Any prior treatment with trimetazidine (TMZ)
- •In the 4 months prior to screening:
- •i. NYHA functional class 3 or 4 HF
- •In the 2 months prior to screening:
- •i. acute coronary syndrome
- •iii. stroke/TIA
- •In the 1 month prior to screening, use of:
- •i. perhexiline
- •ii. meldonium
- •6.Ongoing treatment with heparin or heparin derivatives
- •7.SGLT2 and/or GLP-1 agonist therapy change (initiated or dose
- •changed) within 2 months prior to Visit 1
- •8.Presence of pacemaker, cardiac resynchronization therapy and/or
- •implantable cardioverter defibrillator
- •9. Severe valvular heart disease
- •10.eGFR < 30 ml/min/1.73 m2 (calculated by CKD-EPI).
- •11.ALT /AST and/or bilirubin > 2 x ULN at baseline
- •12.History of Parkinson's disease, Parkinsonian symptoms, or clinically
- •significant restless legs syndrome.
- •13. Exacerbating reversible medical cause for angina (e.g. severe anemia,
- •sustained hypertension defined as persistent BP > 160/90 mmHg,
- •hyperthyroidism).
- •14. Long QT duration at screening (QTcF duration >470 ms for males, and
- •>480 ms for females), or previously diagnosed long QT syndrome, or
- •first degree relative with diagnosed long QT syndrome.
- •15. Permanent atrial fibrillation (AF).
- •16. Left bundle branch block (LBBB)
- •17. BMI =18, or body mass >180 kg that precludes imaging procedures.
- •18. History of alcohol or drug abuse within the prior 2 years
- •19. Female subjects who are of child-bearing potential or who are
- •currently breast
- •20. Male subjects with female partners of child-bearing potential unable
- •and unwilling to
- •practice an approved method of birth control for the duration of the
- •study and until 90
- •days after the last dose of study drug (see section 6.3.1for approved
- •21. Any malignancy currently under active treatment (e.g. chemotherapy,
- •radiation). Patients with a history or concurrent malignancy may be
- •discussed on a case by case basis with the Sponsor. currently under
- 另有 14 项未显示
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