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OpenTrials
Completed

NCT Number: NCT00984802

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Madras Medical Mission, Chennai, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CMX-2043

Drug

Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.

Placebo Control

Drug

Vehicle solution for IV administration single dose.

Primary outcomes

  1. Safety as measured by changes in CK-MB

    Time frame: within 24 hours

Secondary outcomes

  1. Cardiac biomarkers

    Time frame: within 24 hours

  2. ST segment changes

    Time frame: within 24 hours

Sponsors and collaborators

Lead sponsor

Ischemix, LLC

Industry

Registry information

Official study 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)

Acronym: SUPPORT-1

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 25, 2009
Registry last updated
Jun 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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