Percutaneous Coronary Intervention, Stable Coronary Artery Disease
Conditions
Brief summary
This study is conducted to assess the safety of CMX-2043 solution for intravenous (IV) injection, and to evaluate efficacy on the basis of the changes seen in the cardiac biomarkers and continuous electrocardiography (ECG) monitoring. Additionally, correlation of the levels/changes in the biomarkers and the pharmacokinetic evaluations of the drug will be explored.
Interventions
DRUGCMX-2043
Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.
DRUGPlacebo control
Vehicle solution for IV administration single dose.
Sponsors
Ischemix, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who have stable coronary artery disease undergoing elective PCI. * Female subjects not of child-bearing potential. * Absence of ST segment depression \>1.0 mm and absence of ST elevation \>1.0 mm in any lead on the baseline 12-lead ECG. * subjects with CK-MB and troponin-T levels lower than the upper limit of normal. * Subjects free of acute injuries or illnesses.
Exclusion criteria
* Subjects with unstable angina (angina at rest, worsening frequency, duration of angina) or other signs of unstable coronary artery disease. * Subjects who had had an MI within 14 days prior to the PCI procedure. * Subjects with conditions that contraindicate the PCI (e.g. coagulopathy, valvular disease, PVD). * Subjects with history of TIA/stroke within 90 days or any intracranial bleed. * Subjects with creatinine clearance ≥ 1.5 times the upper limit of normal. * Subjects with an active history of psychiatric disorders that is likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements. * Subjects with a history of alcohol or drug abuse. * Subjects with documented history of human immunodeficiency virus (HIV), or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive. * Subjects with uncorrected clinically significant abnormalities of clinical laboratory tests who in the investigators opinion will interfere with the study conduct. * Subject with chronic diseases considered by the anesthetist unfit for surgery and/or who in the opinion of the investigator will increase the risk of the study or obscure the interpretation of results. * Subjects who have participated in a clinical study within 1 month or are currently participating in a clinical study of an investigational agent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety as measured by changes in CK-MB | within 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac biomarkers | within 24 hours |
| ST segment changes | within 24 hours |
Countries
India, United States
Outcome results
None listed