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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00984802
First Posted: September 25, 2009
Last Update Posted: June 20, 2011
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.
Information provided by:
Ischemix, LLC
September 23, 2009
September 25, 2009
June 20, 2011
February 2010
March 2011   (Final data collection date for primary outcome measure)
Safety as measured by changes in CK-MB [ Time Frame: within 24 hours ]
Same as current
Complete list of historical versions of study NCT00984802 on ClinicalTrials.gov Archive Site
  • Cardiac biomarkers [ Time Frame: within 24 hours ]
  • ST segment changes [ Time Frame: within 24 hours ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of CMX-2043 in Subjects Undergoing Coronary Reperfusion Therapy
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Stable Coronary Artery Disease
  • Percutaneous Coronary Intervention
  • Drug: CMX-2043
    Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.
  • Drug: Placebo control
    Vehicle solution for IV administration single dose.
  • Experimental: Low dose
    Intervention: Drug: CMX-2043
  • Experimental: Mid Dose
    Intervention: Drug: CMX-2043
  • Experimental: High Dose
    Intervention: Drug: CMX-2043
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
142
April 2011
March 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India,   United States
 
 
NCT00984802
CMX-2043-2a
No
Not Provided
Not Provided
Duffy Dufresne, Ischemix, LLC
Ischemix, LLC
Not Provided
Study Director: Alan S. Lader, Ph.D. Ischemix, LLC
Ischemix, LLC
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP