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

Primary Purpose

Stable Coronary Artery Disease, Percutaneous Coronary Intervention

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CMX-2043
Placebo control
Sponsored by
Ischemix, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Coronary Artery Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Vincent Hospital
  • Duke University Hospital
  • Madras Medical Mission
  • Hinduja Hospital
  • Poona Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Low dose

Mid Dose

High Dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Safety as measured by changes in CK-MB

Secondary Outcome Measures

Cardiac biomarkers
ST segment changes

Full Information

First Posted
September 23, 2009
Last Updated
June 17, 2011
Sponsor
Ischemix, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00984802
Brief Title
Safety and Efficacy of CMX-2043 in Subjects Undergoing Coronary Reperfusion Therapy
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ischemix, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Coronary Artery Disease, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose
Arm Type
Experimental
Arm Title
Mid Dose
Arm Type
Experimental
Arm Title
High Dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CMX-2043
Intervention Description
Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.
Intervention Type
Drug
Intervention Name(s)
Placebo control
Intervention Description
Vehicle solution for IV administration single dose.
Primary Outcome Measure Information:
Title
Safety as measured by changes in CK-MB
Time Frame
within 24 hours
Secondary Outcome Measure Information:
Title
Cardiac biomarkers
Time Frame
within 24 hours
Title
ST segment changes
Time Frame
within 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan S. Lader, Ph.D.
Organizational Affiliation
Ischemix, LLC
Official's Role
Study Director
Facility Information:
Facility Name
St. Vincent Hospital
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Madras Medical Mission
City
Chennai
ZIP/Postal Code
600 037
Country
India
Facility Name
Hinduja Hospital
City
Mumbai
ZIP/Postal Code
400 016
Country
India
Facility Name
Poona Hospital
City
Pune
ZIP/Postal Code
411 030
Country
India

12. IPD Sharing Statement

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

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