A Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Refrac… (NCT04306237) | Clinical Trial Compass
WithdrawnPhase 2
A Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Refractory Angina
Stopped: Coronavirus pandemic
United States0Started 2020-05-01
Plain-language summary
The objectives of the study are to assess the safety, tolerability, and potential efficacy of IMB-1018972 on patients with refractory angina. Study will assess functional capacity employing a modified Bruce Protocol treadmill ETT, patient reports of angina symptoms via an electronic diary, and activity using an accelerometer.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Is between the ages of 18 and 85 years, inclusive.
✓. Is capable of understanding the written informed consent, and providing signed, dated, and witnessed written informed consent.
✓. Has complied with and is willing to continue to comply with the specified procedures (eg, angina diary during screening) and complete specific follow-up evaluations.
✓. Has coronary artery disease confirmed by at least one of the following:
✓. Has evidence of stress induced ischemia documented by either:
✓. Has a minimum 3 month history of exertional angina, including angina with a minimum frequency of 2 anginal episodes per week on average for the 2 weeks prior to enrolling in the study while on optimal guideline directed medical therapy for their angina.
✓. Is on optimal, dual agent, antianginal therapy for their angina for at least 1 month prior to the first screening ETT. Consistent with ACC/AHA and ESC Class I guideline directed medical therapy (GDMT), criteria for optimal therapy include treatment with both: (a) a beta-adrenergic blocking agent and treatment with (b) a calcium channel blocker OR a long-acting nitrate. If unacceptable side effects are intolerable and documented with a therapy listed in (a) or (b), treatment with only 1 antianginal medication is acceptable. Additionally, patients should be treated with short-acting nitrates per GDMT.
✓. Is currently not clinically indicated for coronary revascularization (ie, PCI or CABG) in the opinion of the principle investigator at the time of screening through 6 months after randomization.
Exclusion criteria
What they're measuring
1
Modified Bruce Protocol Treadmill ETT
Timeframe: 8 weeks
2
Safety and Tolerability of IMB-1018972 in Patients with Refractory Angina
✕. Has a history of moderate to severe valvular heart disease defined as aortic stenosis (valve area \<1.5 cm2), aortic insufficiency, mitral stenosis (valve area \<1.5 cm2), or mitral valve regurgitation of grade 3 or worse.
✕. Has significant hepatic disease, with increased liver function tests such as total bilirubin, aspartate aminotransferase, or alanine aminotransferase more than 2 times of ULN at baseline (excluding patients with documented history of Gilbert syndrome).
✕. Has severe renal impairment (ie, creatinine clearance \<30 mL/min at screening, measured using 4-variable modification of diet in renal disease equation).
✕. Has a history of Parkinson disease, Parkinsonian symptoms, tremors, restless leg syndrome, or other related movement disorders.
✕. Has a history of vasospastic angina or microvascular angina.
✕. Has an exacerbating cause for angina (eg, anemia \[ie, hemoglobin \<10 g/dL\], uncontrolled hypertension \[ie, BP ≥160/90 mmHg\], hyperthyroid, or rapid AF \[ie, AF with average rate \>120 beats per minute\]) at screening.
✕. Has long-QT and life-threatening LV arrhythmia.