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

Phase 2

Completed

• Conditions: Stable Coronary Artery Disease; Percutaneous Coronary Intervention
• Interventions: Drug: Placebo control; Drug: CMX-2043

• Registration Number: NCT00984802
• Lead Sponsor: Ischemix, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-23
• Study First Submitted QC: 2009-09-24
• Study First Posted: 2009-09-25
• Study Start: 2010-02
• Primary Completion: 2011-03
• Study Completion: 2011-04
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-17
• Last Update Posted: 2011-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo control	-
Low dose	CMX-2043	-
High Dose	CMX-2043	-
Mid Dose	CMX-2043	-

Primary Outcome Measures

Name	Time	Method
Safety as measured by changes in CK-MB	within 24 hours

Secondary Outcome Measures

Name	Time	Method
Cardiac biomarkers	within 24 hours
ST segment changes	within 24 hours

Trial Locations

Locations (5)

Madras Medical Mission; 🇮🇳 Chennai, India

Hinduja Hospital; 🇮🇳 Mumbai, India

Poona Hospital; 🇮🇳 Pune, India

St. Vincent Hospital; 🇺🇸 Worcester, Massachusetts, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States