Safety and Efficacy of CMX-2043 in Subjects Undergoing Coronary Reperfusion Therapy (SUPPORT-1)

A Prospective, Randomized, Comparative, Blinded, Placebo-Controlled, Three Different Intravenous Dose, Phase 2a Study of the Safety and Efficacy of CMX-2043 in Subjects Undergoing PCI and Peri-Operative Reperfusion Treatment (SUPPORT-1)

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.

Study Overview

• Status: Completed
• Conditions: Percutaneous Coronary Intervention; Stable Coronary Artery Disease
• Intervention / Treatment: Drug: CMX-2043; Drug: Placebo control

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Chennai, India, 600 037
    • Madras Medical Mission
  • Mumbai, India, 400 016
    • Hinduja Hospital
  • Pune, India, 411 030
    • Poona Hospital
• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01608
      • St. Vincent Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo control; Vehicle solution for IV administration single dose.
Experimental: Low dose	Drug: CMX-2043; Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.
Experimental: High Dose	Drug: CMX-2043; Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.
Experimental: Mid Dose	Drug: CMX-2043; Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety as measured by changes in CK-MB	within 24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Cardiac biomarkers	within 24 hours
ST segment changes	within 24 hours

Collaborators and Investigators

• Sponsor: Ischemix, LLC
• Investigators: Study Director: Alan S. Lader, Ph.D., Ischemix, LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: September 23, 2009
• First Submitted That Met QC Criteria: September 24, 2009
• First Posted (Estimate): September 25, 2009

Study Record Updates

• Last Update Posted (Estimate): June 20, 2011
• Last Update Submitted That Met QC Criteria: June 17, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: CMX-2043-2a