Clinical trial NCT00984802: Safety and Efficacy of CMX-2043 in Subjects Undergoing Coronary Reperfusion Therapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stable Coronary Artery Disease
Percutaneous Coronary Intervention
Lead sponsor: Ischemix, LLC
Sponsor class: INDUSTRY
First posted: 2009-09-25
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Safety as measured by changes in CK-MB
timeFrame: within 24 hours
Secondary outcomes:
measure: Cardiac biomarkers
timeFrame: within 24 hours
measure: ST segment changes
timeFrame: within 24 hours
Other outcomes:
Locations:
city: Worcester
country: United States
facility: St. Vincent Hospital
state: Massachusetts
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Chennai
country: India
facility: Madras Medical Mission
city: Mumbai
country: India
facility: Hinduja Hospital
city: Pune
country: India
facility: Poona Hospital
Study officials:
affiliation: Ischemix, LLC
name: Alan S. Lader, Ph.D.
role: STUDY_DIRECTOR
References: