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

Percutaneous Coronary Intervention Clinical Trial

— SUPPORT-1  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984802
• Other study ID #: CMX-2043-2a
• Status: Completed
• Phase: Phase 2
• First received: September 23, 2009
• Last updated: June 17, 2011
• Start date: February 2010
• Est. completion date: April 2011

Study information

• Verified date: June 2011
• Source: Ischemix, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Percutaneous Coronary Intervention
• Stable Coronary Artery Disease

Intervention

Drug:
• CMX-2043
Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.
• Placebo control
Vehicle solution for IV administration single dose.

Locations

Country	Name	City	State
India	Madras Medical Mission	Chennai
India	Hinduja Hospital	Mumbai
India	Poona Hospital	Pune
United States	Duke University Hospital	Durham	North Carolina
United States	St. Vincent Hospital	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Ischemix, LLC

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as measured by changes in CK-MB		within 24 hours	Yes
Secondary	Cardiac biomarkers		within 24 hours	No
Secondary	ST segment changes		within 24 hours	No