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Completed

NCT Number: NCT04826172

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

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

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Key information

Conditions

Ischemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Imbria Investigational Site, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMB-1018972

Drug

Modified release (MR) oral tablet

Placebo

Drug

Matching oral tablet

Primary outcomes

  1. 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

    Time frame: Randomization through Week 10 Safety Follow-up

Secondary outcomes

  1. 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

    Time frame: Baseline through Week 8

    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

  2. Change in total ischemia burden measured as ischemia score summed across all segments as measured by adenosine stress 15O-H2O PET

    Time frame: Baseline through Week 8

  3. Change in inducible perfusion defect expressed as % of myocardium as measured by adenosine stress 15O-H2O PET

    Time frame: Baseline through Week 8

Sponsors and collaborators

Lead sponsor

Imbria Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2021
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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