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

NCT ID: NCT00984802

Last Updated: 2011-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-04-30

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.

Conditions

Stable Coronary Artery Disease; Percutaneous Coronary Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Low dose

Group Type: EXPERIMENTAL

CMX-2043

Intervention Type: DRUG

Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.

Mid Dose

Group Type: EXPERIMENTAL

CMX-2043

Intervention Type: DRUG

Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.

High Dose

Group Type: EXPERIMENTAL

CMX-2043

Intervention Type: DRUG

Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo control

Intervention Type: DRUG

Vehicle solution for IV administration single dose.

Interventions

CMX-2043

Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.

Intervention Type: DRUG

Placebo control

Vehicle solution for IV administration single dose.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ischemix, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Ischemix, LLC

Principal Investigators

Alan S. Lader, Ph.D.

Role: STUDY_DIRECTOR

Ischemix, LLC

Locations

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

Countries

United States; India

Other Identifiers

CMX-2043-2a

Identifier Type: -

Identifier Source: org_study_id