Ad5FGF-4 In Patients With Refractory Angina Due to Myocardial Ischemia (NCT02928094) | Clinical Trial Compass
UnknownPhase 3
Ad5FGF-4 In Patients With Refractory Angina Due to Myocardial Ischemia
160 participantsStarted 2023-01-01
Plain-language summary
The purpose of this study is to determine whether a single intracoronary infusion of an adenovirus serotype 5 virus expressing the gene for human fibroblast growth factor-4 (Ad5FGF-4) is effective in improving angina-limited exercise duration, angina functional class, frequency of angina attacks, frequency of nitroglycerin usage, and quality of life. Half of the study participants will receive Ad5FGF-4, and half will receive placebo. The primary endpoint is the change from baseline to Month 6 in Exercise Tolerance Test (ETT) duration. Long-term safety of Ad5FGF-4 will also be assessed.
Who can participate
Age range55 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients 55-75 years of age inclusive
✓. Refractory angina CCS Class III or IV
✓. At least 3 angina episodes per week
✓. Diagnostic coronary angiogram in the past 12 months confirming the presence of coronary artery disease in patients who are not candidates for standard interventions (PCI or CABG)
✓. Patients without significant and adequate reduction or relief of angina in spite of treatment with at least two functional classes of chronic anti-angina medication at the maximally tolerated dose. Functional classes of anti-angina medications include β-blockers, calcium channel blockers, nitrates, and metabolic modulators (i.e. ranolazine). Participants must have been on a stable anti-angina medication regimen for at least 4 weeks before signing the informed consent form.
✓. Documented clinical evidence of inducible ischemia on stress testing within the past 6 months \[e.g. nuclear perfusion imaging (stress SPECT or PET), stress ECHO, stress MRI, stress ETT (≥1 mm ST Segment depression)\].
✓. Maximal exercise duration of 3-8 minutes on ETT (Modified Bruce Protocol), with patient physically unable to continue due to angina or angina equivalent (e.g. exhaustion/dyspnea), or when ETT is stopped by person administering the ETT. Patient develops ≥1mm ST segment depression on each of the qualifying baseline ETT
✓. Left ventricular ejection fraction (LVEF) of ≥ 30%
Exclusion criteria
✕. 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 childbearing potential who are not using an acceptable method of birth control (i.e., IUD, oral contraceptive plus barrier contraceptive, hormone delivery system plus barrier contraceptive or condom in combination with contraceptive cream, jelly or foam). Women of childbearing potential with a positive urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) before randomization.
✕. Patients with unstable angina for whom an immediate revascularization procedure (PCI or CABG) is indicated
✕. Patients for whom a cardiac revascularization procedure (PCI or CABG) is planned in the next 3 months
✕. Myocardial infarction within the past 3 months prior to the Screening visit
✕. Congestive heart failure New York Heart Association (NYHA) Class IV
✕. Myocarditis or restrictive pericarditis
✕. Diagnostic coronary angiogram finding of 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)