Clinical trial NCT04826172: Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease (IMPROVE-Ischemia)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemia
Coronary Artery Disease
Lead sponsor: Imbria Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 58
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of IMB-1018972 in subjects with obstructive CAD and inducible ischemia.


Eligibility criteria: Inclusion Criteria:

* Documented history of stable angina (CCS grading I-III) or anginal equivalent for ≥1 month prior to screening
* Ability to safely abstain from beta blockers for 48 hours prior to echo examinations in the opinion of the Investigator
* Preserved LV systolic function, defined as LVEF≥50% by any imaging modality
* Obstructive CAD and recent evidence of stress-induced myocardial ischemia

Exclusion Criteria:

* Women of childbearing potential or who are currently pregnant or breast-feeding
* Clinically indicated for coronary revascularization (PCI/CABG) at time of screening or clinically significant LMS or proximal LAD stenosis likely to warrant revascularization during the study period in the opinion of the investigator.
* Type 1 insulin dependent diabetes mellitus (IDDM)
* Presence of pacemaker, cardiac resynchronization therapy and/or implantable cardioverter defibrillator
* Severe or clinically significant valvular heart disease
* Clinically significant concurrent condition which could prevent the patient from performing any of the protocol-specified assessments, represent a safety concern if the patient participates in the trial or could confound trial assessments of safety or tolerability

Primary outcomes:
measure: Safety and tolerability of IMB-1018972 as measured by incidence and severity of treatment emergent AEs (including AEs leading to study drug discontinuation and AEs leading to death), as well as incidence of treatment emergent SAEs
timeFrame: Randomization through Week 10 Safety Follow-up
Secondary outcomes:
measure: Change in number of ischemic segments during hyperemia (ischemia defined as absolute MBF ≤2.0 ml/kg/min) as measured by adenosine stress 15O-H2O PET
timeFrame: Baseline through Week 8
measure: Change in total ischemia burden measured as ischemia score summed across all segments as measured by adenosine stress 15O-H2O PET
timeFrame: Baseline through Week 8
measure: Change in inducible perfusion defect expressed as % of myocardium as measured by adenosine stress 15O-H2O PET
timeFrame: Baseline through Week 8
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Imbria Investigational Site
city: Turku
country: Finland
facility: Imbria Investigational Site
city: Uppsala
country: Sweden
facility: Imbria Investigational Site
Study officials:
affiliation: Imbria Pharmaceuticals, Inc.
name: Medical Monitor, MD
role: STUDY_CHAIR
References: