Status:
COMPLETED
Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease (IMPROVE-Ischemia)
Lead Sponsor:
Imbria Pharmaceuticals, Inc.
Conditions:
Ischemia
Coronary Artery Disease
Eligibility:
All Genders
35-75 years
Phase:
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2023
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04826172
Start Date
April 23 2021
End Date
September 21 2023
Last Update
April 23 2024
Active Locations (3)
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1
Imbria Investigational Site
Aarhus, Denmark
2
Imbria Investigational Site
Turku, Finland
3
Imbria Investigational Site
Uppsala, Sweden