EUCTR2011-001245-32-BE进行中（未招募）不适用
A Phase 3, Randomized, Double-Blind Trial of Apadenoson for the Detection of Myocardial Perfusion Defects Using Single-Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI) - ASPECT-2
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 670
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
- •Subjects must meet all of the following inclusion criteria to be considered for inclusion in this study:
- •Referred for a clinically indicated rest /pharmacologic stress SPECT-MPI study
- •Male or female subject, 18 years of age or older
- •Must be able to provide written informed consent to participate before beginning any trial related activities
- •Must be able to communicate effectively with trial personnel
- •Subjects must have either high pretest probability of CAD based on age and gender and chest pain symptomatology assessed using the ACC/AHA guidelines for relative risk
- •Have previously demonstrated known coronary artery disease based on medical history of prior myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or diagnostic angiogram demonstrating 50% or greater stenosis in one or more vessel, as well as reporting chest pain indicative of angina or anginal equivalents within the month prior to Pre-Study Evaluation (based on ACC criteria, e.g. dyspnea or extreme fatigue).
- •Can safely abstain from caffeine or methylxanthine containing foods for 24 hours, from dipyridamole for 24 hours, and from theophylline and methylxanthine containing medications for at least 72 hours (or 4 half-lives, whichever is longer)
- •Cardiovascular medication routine must remain stable from the time of signed informed consent through the Period 2 SPECT-MPI
- •If female, be (a) at least one year post menopausal or surgically sterile or (b) nonpregnant (as determined by a negative urine ß-hCG pregnancy test within 24 hours before each period imaging session), and (c) non-lactating. Women of childbearing potential (WOCBP) must have been practicing a medically approved method of birth control since their last menstrual period and be willing to utilize adequate contraception and not become pregnant during the full course of the study. Adequate contraception is defined as continuous use of 1 of the following:
- •o Norplant® (inserted at least 3 months prior to administration)
- •o Medroxyprogesterone acetate injection (given >14 days prior to signed informed consent)
- •o Oral contraception (stable use for 2 or more cycles prior to the time of signed informed consent and throughout the study)
- •o Double-barrier method (e.g., condom or diaphragm plus spermicide, sponge, foam or jelly)
- •o Intrauterine device (IUD, inserted >4 weeks prior to the time of signed informed consent)
- •o Monogamous partner with a bilateral vasectomy (procedure performed >3 months prior to the time of signed informed consent)
- •o Bilateral tubal ligation
- •o Abstinence
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 315
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 355
排除标准
- •Subjects meeting any of the following exclusion criteria will not be included in the study:
- •Ingestion of a caffeinated or methylxanthine food substance (e.g. chocolate, cocoa) within 24 hours before receiving apadenoson or adenosine
- •Treatment with dipyridamole within 24 hours, or theophylline, aminophylline, or pentoxifylline within 72 hours (or 4 half-lives, whichever is longer) prior to receiving apadenoson or adenosine
- •Exposure to any investigational drug or device within 30 days prior to the time of signed informed consent
- •Acute MI, new onset of ischemia or PCI within 30 days prior to SPECT-MPI at either Period 1 or Period 2; or CABG within 90 days prior to SPECT-MPI at either Period 1 or Period 2
- •Any prior allergic response to aminophylline, adenosine, Tc99m Sestamibi, Thallium 201 or Tc99m Tetrofosmin or any of their components or other contraindication to pharmacologic stress testing with adenosine
- •Active severe asthma or severe chronic obstructive pulmonary disease (COPD) which, in the Investigator’s opinion, places the subject at risk for severe bronchoconstriction
- •History or evidence of clinically significant high grade AV block (including type 2 second or third degree block) or sinus node disease, such as sick sinus syndrome or symptomatic bradycardia, in the absence of a functioning permanently implanted pacemaker
- •Evidence of hemodynamically significant valvular disease or outflow tract obstruction
- •Uncontrolled severe hypertension or malignant ventricular arrhythmias
- •Current significant illness or disorder including significant laboratory abnormalities, ECG abnormalities, or other pathology that could potentiate any adverse pharmacological event associated with a vasodilating drug or any abnormality that, in the opinion of the Investigator, could put the subject at risk
- •Pretreatment hypotension (systolic BP < 90 mm Hg) or tachycardia (HR > 100 bpm)
- •Known history of cerebral vascular accident or suspected transient ischemic attack within 30 days prior to signed informed consent
- •Psychological or addictive disorder which may interfere with an ability to provide informed consent
研究者
相似试验
进行中（未招募）
不适用
This is a trial of apadenoson, an investigational drug, for the detection of Myocardial Perfusion Defects using Single Photon Emission Computed Tomography Myocardial Perfusion Imaging (SPECT-MPI).MedDRA version: 14.1Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disordersCoronary Artery DiseaseEUCTR2011-001245-32-NLForest Laboratories, Inc.670
进行中（未招募）
1 期
A Phase 3, Randomized, Double-blind Study of Chemotherapy plus Nivolumab versus Chemotherapy plus Placebo provided before surgery, followed by Nivolumab or Placebo provided after surgery for Participants with Non-small Cell Lung Cancer which can be completely removed by surgery.Resectable Stage II-IIIB Non-small cell lung cancerMedDRA version: 20.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-000262-38-ITBristol-Myers Squibb International Corporation750
进行中（未招募）
1 期
A Phase 3, Randomized, Double-blind Study of Chemotherapy plus Nivolumab versus Chemotherapy plus Placebo provided before surgery, followed by Nivolumab or Placebo provided after surgery for Participants with Non-small Cell Lung Cancer which can be completely removed by surgery.Resectable Stage II-IIIB Non-small cell lung cancerMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-000262-38-NLBristol-Myers Squibb International Corporation750
进行中（未招募）
1 期
A Phase 3, Randomized, Double-blind Study of Chemotherapy plus Nivolumab versus Chemotherapy plus Placebo provided before surgery, followed by Nivolumab or Placebo provided after surgery for Participants with Non-small Cell Lung Cancer which can be completely removed by surgery.EUCTR2019-000262-38-ROBristol-Myers Squibb International Corporation750
进行中（未招募）
1 期
A Phase 3, Randomized, Double-blind Study of Chemotherapy plusNivolumab versus Chemotherapy plus Placebo provided before surgery,followed by Nivolumab or Placebo provided after surgery for Participantswith Non-small Cell Lung Cancer which can be completely removed bysurgery.Resectable Stage II-IIIB Non-small cell lung cancerMedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864CTIS2022-502658-15-00Bristol Myers Squibb International Corporation750