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CTRI Number  CTRI/2010/091/000201 [Registered on: 10/03/2010]
Last Modified On: 02/04/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Drug
Other (Specify) [Injectable]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the safety and efficacy of CMX-2043 in Subjects Undergoing PCI and Peri-Operative Reperfusion Treatment (SUPPORT-1) 
Scientific Title of Study   A Prospective, Randomized (3:1), 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) 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
CMX-2043 -2a  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr C K Ponde 
Designation  Principal Investigator 
Affiliation  P. D. Hinduja National Hospital & Medical Research Centre 
Address  P. D. Hinduja National Hospital & Medical Research Centre,
Veer Savarkar Marg, Mahim,
Mumbai
MAHARASHTRA
Mumbai - 400016
India 
Phone  919820186502  
Fax  912224440425  
Email  ckpshekhar@yahoo.co.in  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Prashant Pandya 
Designation  DGM - Clinical Operations 
Affiliation  Reliance Life Sciences Pvt. Ltd.  
Address  Reliance Clinical Research Services, a division of Reliance Life Sciences Pvt. Ltd. Dhirubhai Ambani Life Sciences Centre (DALC),
Plot R-282, TTC Area of MIDC, Rabale,
Mumbai
MAHARASHTRA
Navi Mumbai 400 701
India 
Phone  02240678236  
Fax  02240678299  
Email  Prashant.Pandya@relbio.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Prashant Pandya 
Designation  DGM- Clinical operations 
Affiliation  Reliance Life Sciences Pvt. Ltd. 
Address  Reliance Clinical Research Services, a division of Reliance Life Sciences Pvt. Ltd. Dhirubhai Ambani Life Sciences Centre (DALC),
Plot R-282, TTC Area of MIDC, Rabale,
Mumbai
MAHARASHTRA
Navi Mumbai 400 701
India 
Phone  02240678236  
Fax  02240678299  
Email  Prashant.Pandya@relbio.com  
 
Source of Monetary or Material Support  
Reliance Clinical Research Services, a division of Reliance Life Sciences Pvt. Ltd. Dhirubhai Ambani Life Sciences Centre (DALC), Plot R-282, TTC Area of MIDC, Rabale, Navi Mumbai 400 701  
 
Primary Sponsor
Modification(s)  
Name  Ischemix LLC  
Address  63 Great Road Maynard, MA 01754 Tel.: +1 978 897 5139 Fax: +1 978 897 4952 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Chandrashekar Ponde  P.D. Hinduja Naitonal Hospital and Medical Research Centre,   Veer Savarkar Marg, ,Mahim, Mumbai 400 016, India.-Mumbai 400 016
Mumbai
MAHARASHTRA 		 +91 98201 86502, 02224447178, +912230596500
+91 22 24440425
ckpshekhar@yahoo.co.in 
Dr Jagdish Hiremath  Poona Hospital and Research Centre,   27, Sadashiv Peth,Pune 411030 India
Pune
MAHARASHTRA 		 919822022441
910224338181
drjagdishhiremath@gmail.com 
Dr. Ajit Mullasari  The Madras Medical Mission  4-A, DR J. Jayalalithaa Nagar, ,Mogappair, Chennai 600 037, India-Chennai 600 037, India

 		 +91 98412 71361
+91 44 26565510/ 26565974
icvddoctors@mmm.org.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
1. Institutional Ethics Committee, The Madras Medical Mission, 4-A, DR J. Jayalalithaa Nagar, Mogappair, Chennai 600 037, , India,  Approved 
2. National Health and Education society, Clinical Research and Ethics Committee, P.D. Hinduja National Hospital & Medical Research Centre, Veer Savarkar Marg, Mahim, Mumbai, 400 016, India  Approved 
3. Poona Hospital & Research Centre, 27, Sadashiv Peth Pune ? 411030 India  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Re-perfusion injury in subjects undergoing PCI and Peri-operative reperfusion ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CMX-2043   CMX-2043 0.8 mg/kg, 1.2 mg/kg, or 2.4 mg/kg  
Comparator Agent  Placebo  Placebo 2.4 mg/kg  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the safety  Measuring the changes in CK-MB values up to 24 hours after the last balloon inflation 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate reduction of myocardial injury associated with stent PCI  Determined by serial measurements of cardiac biomarkers. 
 
Target Sample Size
Modification(s)  		 Total Sample Size="142"
Sample Size from India="119" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)
Modification(s)  		 02/03/2010 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  02/03/2010 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Will Provide on request. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a prospective, multi-center, blinded, randomized, placebo-controlled study, evaluating single-dose regimens of CMX-2043 (three doses) solution for IV administration or placebo (single dose) in subjects with stable coronary artery disease undergoing elective placement of stent by Percutaneous Coronary Intervention (PCI). Approximately 30 subjects will be randomized to each study group: low dose (0.8 mg/kg), medium dose (1.6 mg/kg), high dose (2.4 mg/kg) or placebo (0.24 mL/kg). The study aims to have a minimum of 120 evaluable subjects, defined as those subjects who have received the study medication dose and complete 24 hours after the last balloon inflation. The IV route of administration has been chosen as the appropriate method of delivery. 
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