Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease (IMPROVE-Ischemia)

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04826172
• Other study ID #: IMB101-006
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 23, 2021
• Est. completion date: September 2023

Study information

• Verified date: August 2023
• Source: Imbria Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Ischemia

Intervention

Drug:
• IMB-1018972
Modified release (MR) oral tablet
• Placebo
Matching oral tablet

Locations

Country	Name	City	State
Denmark	Imbria Investigational Site	Aarhus
Finland	Imbria Investigational Site	Turku
Sweden	Imbria Investigational Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Imbria Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Denmark,  Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Randomization through Week 10 Safety Follow-up
Secondary	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	Ischemia score defined on the basis of absolute hyperemic MBF as: (1) MBF 2.0-2.3 ml/g/min; (2) 1.7- 2.0 ml/g/min; (3) MBF <1.7 ml/g/min	Baseline through Week 8
Secondary	Change in total ischemia burden measured as ischemia score summed across all segments as measured by adenosine stress 15O-H2O PET		Baseline through Week 8
Secondary	Change in inducible perfusion defect expressed as % of myocardium as measured by adenosine stress 15O-H2O PET		Baseline through Week 8