Safety and Efficacy of CMX-2043 in Subjects Undergoing Coronary Reperfusion Therapy

Completed · Phase 2 · Has a placebo group

Conditions studied: Stable Coronary Artery Disease, Percutaneous Coronary Intervention

In brief

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.

Key facts

Study ID

NCT00984802

Run by

Ischemix, LLC

People needed

142

Starts

2010-02-01

Expected to finish

2011-04-01

Last updated by the study team

2011-06-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• St. Vincent Hospital — Worcester, Massachusetts, United States
• Duke University Hospital — Durham, North Carolina, United States
• Madras Medical Mission — Chennai, India
• Hinduja Hospital — Mumbai, India
• Poona Hospital — Pune, India

Full record on ClinicalTrials.gov

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