NCT01550614终止3 期
A Randomized, Controlled, Parallel Group, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Ad5FGF-4 Using SPECT Myocardial Perfusion Imaging in Patients With Stable Angina Pectoris
Cardium Therapeutics1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2012年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in reversible perfusion defect size (RPDS) as measured by adenosine triphosphate (ATP) single-photon emission computed tomography with technetium-99m sestamibi (SPECT)
研究概览
简要总结
The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4, delivered during induced transient ischemia, is effective in improving myocardial perfusion, angina functional class, patient symptoms, and quality of life. Short-term (8 weeks) and long-term (12 month) safety of Ad5FGF-4 will also be evaluated. The primary endpoint is change in adenosine triphosphate (ATP) stress SPECT reperfusion defect size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18-75 years of age, inclusive
- •Postmenopausal female patients, women of childbearing potential and men willing to use an effective contraception method while on the study treatment and/or who agree not to become pregnant or make their partner pregnant throughout the study and during one year after administration of the study drug
- •Female subjects of childbearing potential who have a negative urine pregnancy test, and are willing to use an acceptable form of birth control during the study
- •Diagnostic coronary angiogram in the past confirming the presence of coronary artery disease. Patients with extensive disease, or high risk for intervention, or who don't want the higher risk angioplasty or surgery, or have had angioplasty with recurrent angina and vessels are not ideal for angioplasty are ideal candidates
- •Stable angina pectoris being treated with chronic anti-anginal medication(s) at a stable dose for 2 weeks prior to randomization
- •Left ventricular ejection fraction (LVEF) of ≥30%. If the LVEF is <30% the patient can be enrolled if there is no recent or current congestive heart failure present
- •Evidence of stress induced myocardial ischemia by ATP technetium-99m sestamibi SPECT, defined as a reversible perfusion defect size of ≥9%
- •Willing and able to comply with the study requirements
- •Provided written informed consent
排除标准
- •Female patients who are pregnant, lactating (breast milk feeding), or planning a pregnancy during the course of the study and one year after administration of the study drug. Women of child bearing potential who are not using an acceptable method of birth control. Women of child bearing potential with a positive urine pregnancy test within 24 hours prior to the start of investigational product
- •Patients with unstable angina for whom an immediate revascularization procedure is indicated
- •Patients for whom a cardiac revascularization procedure is planned in the next 3 months
- •Myocardial infarction within the 3 months prior to the Screening visit
- •Congestive heart failure NYHA Class IV
- •Myocarditis or restrictive pericarditis
- •Left main coronary stenosis ≥70% (unless the patient has a patent graft or collateral vessels supplying the left coronary circulation) or proximal stenoses ≥70% in all major coronary conduit vessels (coronary arteries and bypass grafts)
- •A single patent coronary conduit (for example, totally occluded RCA and LCx with no bypass grafts. Patient will not tolerate balloon occlusion of the LAD for infusion)
- •Clinically significant aortic or mitral valvular heart disease.
- •Life threatening coronary ostial stenosis that precludes adequate catheter engagement in any target vessel, unless the vessel can be accessed via a patent bypass graft
- •Coronary artery to venous communications, which bypass the coronary capillary bed
- •Untreated life-threatening ventricular arrhythmias
- •Uncontrolled arterial hypertension with systolic blood pressure >180 mm Hg and diastolic pressure >100 mm Hg
- •CABG surgery within the past 6 months, unless those grafts are now occluded
- •Percutaneous transluminal coronary angioplasty (PTCA) within the past 3 months, unless the stented/dilated vessel(s) are now occluded
- •Enhanced external counterpulsation (EECP) within 3 months prior to the start of screening evaluations
- •Transmyocardial or percutaneous myocardial laser revascularization within the previous year
- •Prior treatment with any cardiovascular gene therapy
- •Patients who received an investigational drug or biologic within 30 days of screening or are currently participating in an investigational drug, biologic or device trial
研究组 & 干预措施
Arm B
No Intervention
Standard of care angina medication
Arm A: Ad5FGF-4
Experimental
Adenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer and standard of care angina medication
干预措施: Alferminogene tadenovec (Genetic)
结局指标
主要结局
Change in reversible perfusion defect size (RPDS) as measured by adenosine triphosphate (ATP) single-photon emission computed tomography with technetium-99m sestamibi (SPECT)
时间窗: Baseline and Week 8
次要结局
- Change in quality of life using the Seattle Angina Questionnaire(Baseline and Week 8)
- Long-term safety of Ad5FGF-4 as assessed by serious adverse events(Through Month 12)
- Change in angina frequency and nitroglycerin use(Baseline and Week 8)
- Change in patient functional class using CCS anginal classification(Baseline and Week 8)
- Safety of Ad5FGF-4 as assessed by adverse events and clinical laboratory testing(Through Week 8)
研究者
研究点 (1)
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