Status:
COMPLETED
Safety and Efficacy of CMX-2043 in Subjects Undergoing Coronary Reperfusion Therapy
Lead Sponsor:
Ischemix, LLC
Conditions:
Stable Coronary Artery Disease
Percutaneous Coronary Intervention
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 ele...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00984802
Start Date
February 1 2010
End Date
April 1 2011
Last Update
June 20 2011
Active Locations (5)
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1
St. Vincent Hospital
Worcester, Massachusetts, United States, 01608
2
Duke University Hospital
Durham, North Carolina, United States, 27705
3
Madras Medical Mission
Chennai, India, 600 037
4
Hinduja Hospital
Mumbai, India, 400 016