EUCTR2016-000629-38-NL进行中（未招募）1 期
A randomized, double-blind, placebo-controlled parallel arm dose titration study to assess the effects of SAR407899 in patients with microvascular angina and/or persistent stable angina despite angiographically successful elective percutaneous coronary intervention (PCI)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
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
入选标准
- •- Male or female patient not at childbearing potential =18 year-old or legal age of majority.
- •- Female patient if she has undergone sterilization at least 3 months earlier or is postmenopausal.
- •- Post-menopausal status is defined by having no menses for 12 months without an alternative medical cause.
- •- In females not treated with hormonal replacement therapy (HRT), menopausal status is confirmed by a high follicle stimulating hormone (FSH) level greater than 40 IU/L.
- •- In females on HRT and whose menopausal status is in doubt (ie, in women aged less than 45 years), a highly effective contraception methods will be required. Contraception should be used during the whole study and for at least seven days corresponding to time needed to eliminate study treatment.
- •- Symptomatic stable angina pectoris (typical or atypical symptoms with at least once weekly episodes),
- •- Electrocardiogram (ECG) evidence of ischemia with
- •ST-segment depression during a symptom limited exercise test or non-invasive evidence of ischemia [echo, single photon emission computed tomography (SPECT), magnetic resonance imaging (MRI), positron emission tomography (PET)] within previous 12 months.
- •- Patients with normal” or subnormal” (<50% stenosis) coronary arteries or intermediate stenosis (between 50 and 70%) should have fractional flow reserve (FFR) >0.80 on angiogram documented within the previous 12 months. In patients with stenting, a minimum diameter stenosis of <10% is required.
- •Coronary computed tomography angiography (CCTA) without regional abnormal perfusion defects within 12 months in patients without previous PCI.
- •- Baseline global CFR (measured during the study) assessed by 13N-ammonia or 82rubidium PET scan <2.0.
- •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 183
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 77
排除标准
- •- Esophageal dysmotility or esophagitis.
- •- Any use of long-acting nitrates and/or calcium channel blockers (CCBs) and/or phosphodiesterase type 5 (PDE5) inhibitors within one week prior to baseline PET scan or anticipated to be used during the study.
- •- Patients with acute coronary syndrome (ACS) [myocardial infarction (MI) and/or unstable angina] in previous 3 months.
- •- Unsuccessful or incomplete coronary revascularization with residual obstructive stenosis or coronary artery disease (CAD) progression in native vessels as documented on invasive coronary angiography (=50% stenosis) within 12 months of enrollment.
- •- Patients with history of coronary artery bypass grafting (CABG).
- •- Percutaneous coronary intervention performed at the time of an ACS (MI or unstable angina).
- •- Recent elective PCI within the past 3 months.
- •- Contraindication to vasodilator stress PET scan.
- •- Regional local flow abnormal perfusion defects at baseline PET scan.
- •- Recent (=3 months) major surgery (ie, valvular surgery, surgery for congenital heart disease), stroke, transient ischemic attack (TIA), sustained ventricular arrhythmia, clinically significant structural heart disease (moderate-severe valvular disease, hypertrophic cardiomyopathy, congenital heart disease, pulmonary hypertension).
- •- Patients with cardiac conduction abnormalities (second or third degree atrioventricular [AV] block, sick sinus syndrome, symptomatic bradycardia, sinus node disease).
- •- History of known carotid stenosis.
- •- Contraindication or known hypersensitivity to adenosine (or regadenoson).
- •- Contraindication to aminophylline.
- •- Ongoing dipyridamole treatment.
- •- Inability to discontinue treatment with methylxanthines treatment within 24 hours prior to PET scan.
- •- Patient unable to read, understand and fill a questionnaire without any help (eg, partially visually impaired or blind).
- •- Systolic Blood Pressure (SBP) <120 mmHg at baseline.
- •- Presence at baseline of symptomatic orthostatic hypotension (SBP decrease of 20 mmHg or more at Minute 3 and Minute 5 between seated and standing position), or asymptomatic orthostatic hypotension with a decrease in SBP equal or greater than 30 mmHg at Minute 3 and Minute 5 when changing from the seated to the standing position.
- •- Renal impairment [estimated glomerular filtration rate (eGFR) <50 milliliter (mL)/min/1.73m2 at screening and baseline].
- •- Drug-induced liver injury related criteria:
- •- Underlying hepatobiliary disease,
- •- ALT >3 times the upper limit of normal (ULN).
研究者
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