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

This study has been completed.
Sponsor:
Information provided by:
Ischemix, LLC
ClinicalTrials.gov Identifier:
NCT00984802
First received: September 23, 2009
Last updated: June 17, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Stable Coronary Artery Disease
Percutaneous Coronary Intervention
 Drug: CMX-2043
Drug: Placebo control
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ischemix, LLC:

Primary Outcome Measures:
  • Safety as measured by changes in CK-MB [ Time Frame: within 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cardiac biomarkers [ Time Frame: within 24 hours ] [ Designated as safety issue: No ]
  • ST segment changes [ Time Frame: within 24 hours ] [ Designated as safety issue: No ]

Enrollment: 142
Study Start Date: February 2010
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984802

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

No publications provided

Responsible Party: Duffy Dufresne, Ischemix, LLC
ClinicalTrials.gov Identifier: NCT00984802     History of Changes
Other Study ID Numbers: CMX-2043-2a
Study First Received: September 23, 2009
Last Updated: June 17, 2011
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013