A clinical trial to study the safety and efficacy of CMX-2043 in Subjects Undergoing PCI and Peri-Operative Reperfusion Treatment (SUPPORT-1)
- Conditions
- Health Condition 1: null- Re-perfusion injury in subjects undergoing PCI and Peri-operative reperfusion
- Registration Number
- CTRI/2010/091/000201
- Lead Sponsor
- Ischemix LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 142
1. Male or female subjects of 18 to 70 years of age (both inclusive).
2. Subjects with stable coronary artery disease, documented by coronary angiography within 28 days of PCI procedure.
3. Subjects who have stable coronary artery disease undergoing elective PCI (planned placement of a single stent of ≥ 18 mm or multiple stents).
4. Female subjects:
a. Surgically sterile with documented bilateral tubal ligation or hysterectomy
OR
b. documented to be post-menopausal for at least one year
OR
c. if of child-bearing potential, practicing an acceptable method of birth control for the duration of the study as judged by the investigator, such as condoms, foams, jellies, diaphragm, intrauterine device or abstinence.
5. 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.
6. Subjects with CK-MB and troponin-T levels lower than the upper limit of normal as determined at local site laboratory.
7. Subjects free of acute injuries or illnesses that in the opinion of the investigator could increase the risk of the study to the subject or obscure the interpretation of results.
8. Subjects willing to undergo pre-and post-study physical exams and laboratory investigations.
9. Subjects willing to provide signed written informed consent form
1. Subjects with unstable angina (angina at rest, worsening frequency, duration of angina) or other signs of unstable coronary artery disease.
2. Subjects who had had an MI within 14 days prior to the PCI procedure.
3. Subjects with conditions that contraindicate the PCI (e.g. coagulopathy, valvular disease, PVD).
4. Subjects with history of TIA/stroke within 90 days or any intracranial bleed.
5. Subjects with plasma creatinine level ≥ 1.5 times the upper limit of normal.
6. 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.
7. Subjects with a history of alcohol or drug abuse.
8. Subjects with documented history of human immunodeficiency virus (HIV), or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
9. Subjects with uncorrected clinically significant abnormalities of clinical laboratory tests who in the investigators opinion will interfere with the study conduct.
10. 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.
11. Subjects who have participated in a clinical study within 1 month or are currently participating in a clinical study of an investigational agent.
12. A known history of drug hypersensitivity to CMX-2043 or any of the excipients of CMX-2043.
13. Any other medical condition or reason that, in the Investigator's opinion, makes the subject unsuitable to participate in this clinical trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safetyTimepoint: Measuring the changes in CK-MB values up to 24 hours after the last balloon inflation
- Secondary Outcome Measures
Name Time Method To evaluate reduction of myocardial injury associated with stent PCITimepoint: Determined by serial measurements of cardiac biomarkers.