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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00984802
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : June 20, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Stable Coronary Artery Disease Percutaneous Coronary Intervention Drug: CMX-2043 Drug: Placebo control Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

Arm Intervention/treatment
Experimental: Low 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.

Experimental: High Dose Drug: CMX-2043
Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.

Placebo Comparator: Placebo Drug: Placebo control
Vehicle solution for IV administration single dose.

Primary Outcome Measures :
  1. Safety as measured by changes in CK-MB [ Time Frame: within 24 hours ]

Secondary Outcome Measures :
  1. Cardiac biomarkers [ Time Frame: within 24 hours ]
  2. ST segment changes [ Time Frame: within 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00984802

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United States, Massachusetts
St. Vincent Hospital
Worcester, Massachusetts, United States, 01608
United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27705
Madras Medical Mission
Chennai, India, 600 037
Hinduja Hospital
Mumbai, India, 400 016
Poona Hospital
Pune, India, 411 030
Sponsors and Collaborators
Ischemix, LLC
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Study Director: Alan S. Lader, Ph.D. Ischemix, LLC

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Responsible Party: Duffy Dufresne, Ischemix, LLC Identifier: NCT00984802     History of Changes
Other Study ID Numbers: CMX-2043-2a
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: June 20, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Thioctic Acid
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Growth Substances