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CTRI Number  CTRI/2011/05/001713 [Registered on: 05/05/2011] Trial Registered Prospectively
Last Modified On: 28/03/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the safety and efficacy of the study drug when added to atorvastatin plus standard of care in subjects with Acute Coronary syndromes (ACS). 
Scientific Title of Study   Evaluation of the Safety and Efficacy of Short-term A-002 Treatment in Subjects with Acute Coronary Syndromes. 
Secondary IDs if Any  
Secondary ID  Identifier 
AN-CVD2233  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Bankim Chauhan 
Designation  Senior Project Manager 
Affiliation  Trident Clinical Research India Pvt. Ltd. 
Address  Trident Clinical Research India Pvt. Ltd.
Office No. 4, 3rd Floor, BIZ Park, Road No 16U, Wagle Estate, MIDC, Thane (West)
Thane
MAHARASHTRA
400604
India 
Phone  022-25800414  
Fax  02225800417  
Email  bchauhan@tridentclinicalresearch.com  
 
Details of Contact Person
Scientific Query
 
Name  DrBankim Chauhan 
Designation  Senior Project Manager 
Affiliation  Trident Clinical Research India Pvt. Ltd. 
Address  Trident Clinical Research India Pvt. Ltd.
Office No. 4, 3rd Floor, BIZ Park, Road No 16U, Wagle Estate, MIDC, Thane (West)
Thane
MAHARASHTRA
400604
India 
Phone  022-25800414  
Fax  02225800417  
Email  bchauhan@tridentclinicalresearch.com  
 
Details of Contact Person
Public Query
 
Name  Dr Samir Sadekar 
Designation  Managing Director 
Affiliation  Trident Clinical Research India Pvt. Ltd. 
Address  Trident Clinical Research India Pvt. Ltd.
Office No. 4, 3rd Floor, BIZ Park, Road No 16U, Wagle Estate, MIDC, Thane (West)
Thane
MAHARASHTRA
400604
India 
Phone  022-25800414  
Fax  022-25800417  
Email  ssadekar@tridentclinicalresearch.com  
 
Source of Monetary or Material Support  
Anthera Pharmaceuticals, Inc. 25801 Industrial Boulevard, Suite B Hayward, CA 94545 U.S.A. 
 
Primary Sponsor  
Name  Anthera Pharmaceuticals Inc  
Address  25801 Industrial Boulevard, Suite BHayward, CA 94545U.S.A. 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Trident Clinical Research India Pvt Ltd   Office No. 4, 3rd Floor, BIZ Park, Road No 16U, Wagle Estate, MIDC, Thane (W)- 400604. Maharashtra. India 
 
Countries of Recruitment     Australia
Canada
Czech Republic
Georgia
Germany
Hungary
India
Italy
Lebanon
Netherlands
New Zealand
Poland
Russian Federation
Spain
Ukraine
United States of America  
Sites of Study
Modification(s)  
No of Sites = 17  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Dhiman Kahali  B. M. Birla Heart Research Centre  1/1, National Library,Avenue-700027
Kolkata
WEST BENGAL 
00991 33 24567890
0091 3324567000
dr.kahali@gmail.com 
Dr. Darshan Banker  Banker Heart Institute  Near Tagorenagar,Opp. Suryakiran Complex,-390 015
Vadodara
GUJARAT 
0091 265 2324004
0091 265 2327401
dnb@bankerheart.com 
Dr Gulla Suryaprakash  Care Hospitals  Care Hospitals, Near Clock Tower, Market Street, Secunderabad-500003, Andhra Pradesh, India.
Hyderabad
ANDHRA PRADESH 
00914030114555
00914030114545
suryaprakashgulla@gmail.com 
Dr. Keyur Parikh  Care Institute of Medical Sciences  Opp. Panchamrut Bunglows, Near Shukan Mall,Off Science City Road, Sola-380 060
Ahmadabad
GUJARAT 
00 91 27712771
0091 27712777
keyur.parikh@heartcareclinic.org  
Dr. Shailendra Trivedi  CHL Apollo Hospitals  A. B. Road,Near LIG triangle-452 008
Indore
MADHYA PRADESH 
0091 731 2549090
0091 731 4245625
shailoo60@yahoo.com  
DrAtul Abhyankar  Heart First Cardiac and Vascular & Vascular Cener  Heart First Cardiac & Vascular Centre F-10 3rd Floor Sheron Plaza Athwalines Road Parel Point Surat-395007 Gujarat - India
Surat
GUJARAT 
00912612254888
00912613072829
atulda@hotmail.com 
DrArup Dasbiswas  ICVS-IPGMER & SSKM Hospital  ICVS-IPGMER & SSKM Hospital,244,Acharya Jagdish Chandra Bose Road, Kolkata-700020, West Bengal,India
Kolkata
WEST BENGAL 
00913322237159
00913322237159
arup.dasbiswas@gmail.com 
Dr. Rajeev Rajput  Indraprastha Apollo Hospitals  Sarita Vihar, ,-110076
New Delhi
DELHI 
0091 11 26925825
0091 11 41677024
rajeeve_kumar@hotmail.com 
Dr. Rajendra Kumar Premchand  Krishna Institute of Medical Sciences  1-8-31/1, Minister Road, ,-500003

 
0091 40 44885363
0091 40 27845555
kumarpre@hotmail.com  
Dr. Sameer Dani  Lifecare Institute of Medical Sciences & Research  Sardar Patel Statute Corner,Stadium Road, Naranpura-380014
Ahmadabad
GUJARAT 
0091 79 40204020
0091 79 40204303
danisameer@hotmail.com 
Dr Prakash Vadaganelli  M S Ramaiah Memorial Hospital  Sathayanarayana,MSR Nagar, MSRIT Post-560 0034
Bangalore
KARNATAKA 
0091 80-23608888
0091 80-236030
drprakashvs@gmail.com 
Dr. Sandeep Gupta  M.V. Hospital and Research Centre  314/30 Mirza Mandi Chowk,,-226003
Lucknow
UTTAR PRADESH 
0091 522 2258215
05224016051
sandeepkumar.gupta@gmail.com 
Dr. K. Sarat Chandra  Nizam Institute of Medical Sciences  Dept. of Cardiology,Punjagutta-500082
Hyderabad
ANDHRA PRADESH 
0091 40 23489108
009140 23310076
saratkoduganti@hotmail.com  
Dr. Mahesh Fulwani  Shrikrishna Hrudayalaya and Critical Care Centre  Opposite New English School,Congress Nagar Square, Dhantoli-440012
Nagpur
MAHARASHTRA 
0091 71 22444434
0091 71 22440120
maheshfulwani@yahoo.co.in 
Dr. Kamaldeep Chawla  Sterling Hospital  Opp. Inox Race Course Circle (West),-390 007
Vadodara
GUJARAT 
0091 265 2354455
0091265 2352900
kychawla@rediffmail.com 
Dr. Shrenik Shah  Sterling Hospital  Sterling Hospitals Road,Memnagar-380052
Ahmadabad
GUJARAT 
0091 79-40011622
0091 79-40011622
dr_shrenik@yahoo.co.in 
DrCharit Bhograj  Vikram Hospital  Vikram Hospital, No 71/1, Millers Road, Bangalore-560 052, Karnataka, India
Bangalore
KARNATAKA 
00918045004500
00918045004698
drcharit@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 17  
Name of Committee  Approval Status 
B.M.Birla Heart Research Centre Etics Committee  Approved 
Banker Heart Institute Ethics Committee  Approved 
Central India Medical Research Ethics Committee  Approved 
CHL Apollo Hospitals Ethics Committee  Approved 
Ethics Committee of Care Institute of Medical Science  Approved 
Ethics Committee of Lifecare Institute of Medical Sciences & Research  Approved 
Ethics Committee of M.V. Hospital and Research Centre  Approved 
Ethics Committee of Nizam Institute of Medical Sciences  Approved 
Ethics Committee of Sterling Hospital, Ahmedabad  Approved 
Heart First Ethics Committee  Approved 
IEC Consultants Care Foundation  Approved 
Indraprastha Apollo Hospitals Ethics Committee  Approved 
Institutional Ethical Committee  Approved 
IPGME&R Research Oversight Committee  Approved 
Krishna Institute of Medical Science Institutional Ethics committee  Approved 
M S Ramaiah Memorial Hospital Ethics Committee  Approved 
Sterling Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Acute Coronary Syndromes 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral A-002 and atorvastatin more than or equal to 20 mg/day  500 mg QD,as two 250 mg tablets for 16 weeks 
Comparator Agent  Oral placebo and atorvastatin more than or equal to 20 mg/day  500 mg QD,as two 250 mg tablets for 16 weeks 
 
Inclusion Criteria
Modification(s)  
Age From  40.00 Year(s)
Age To  0.00 Day(s)
Gender  Both 
Details  1. Men and women equal and above 40 years of age
2. A diagnosis of unstable angina, non-ST-segment elevation myocardial infarction (NSTEMI), or ST-segment elevation
myocardial infarction (STEMI)
Unstable angina is defined as:
Chest pain symptomatic of ischemia or angina occurring at
rest or on minimal exertion with a pattern of increasing
frequency or severity, lasting 10 minutes and consistent
with myocardial ischemia within 24 hours prior to
hospitalization, new or dynamic ST-segment depression or prominent T-wave inversion changes in at least 2 contiguous leads.
In addition subjects meeting the above criteria for unstable angina must also have either troponin I, troponin T or CK-MB above the LLD but below the 99th percentile of the upper reference limit (URL) and not due to cardioversion or underlying cardiovascular (CHF, cardiomyopathy) or renal disease.
NSTEMI is defined as:
Chest pain symptomatic of ischemia, No electrocardiogram (ECG) changes, or ST-depression, or T wave changes (i.e., no new Q waves on serial ECGs) and increase in cardiac troponin local limit for the definition of myocardial infarction or increase in CK-MB isoenzyme URL
STEMI is defined as:
Chest pain symptomatic of ischemia, ST segment elevation and associated T wave changes or ST-segment elevation of at least 2 mm in 2 contiguous leads, either of which persisting for longer than 15 minutes and increase in cardiac troponin local limit for the definition of myocardial infarction or increase in CK-MB URL

3. All subjects (unstable angina, NSTEMI, or STEMI) must have the presence of at least one of the following risk factors:
i. Diabetes Mellitus or
ii. Presence of any 3 of the following characteristics of
metabolic syndrome
- Waist circumference 102 cm in males, 88 cm in females
- Serum triglycerides greater than or equal to 150 mg/dL (greater than or equal to 1.7 mmol/L)
- HDL-C 40 mg/dL (1 mmol/L) in males, 50 mg/dL (1.3 mmol/L) in females
- Blood pressure greater than or equal to 130/85 mmHg
- Plasma glucose greater than or equal to 110 mg/dL (greater than or equal to 6.1 mmol/L) or
iii. history of cerebrovascular disease (stroke or TIA) or
iv. history of peripheral vascular disease or
v. previous CABG or
vi. previous documented myocardial infarction or
vii. previous coronary revascularization
5. Subjects must be randomized within less than or equal to 96 hours of hospital admission for the index event, or if already hospitalized, within less than or equal to 96 hours of index event diagnosis
6. Revascularization, if required or planned, must occur prior to
randomization 
 
ExclusionCriteria 
Details  1. Subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to Screening.
2. Subjects treated for cancer within the previous 5 years except for skin basal cell carcinoma or carcinoma in situ of the cervix, with measures other than a minor, complete surgical excision or radiation therapy (e.g. chemotherapy)
3. The presence of any severe liver disease with cirrhosis, active hepatitis, active chronic hepatitis, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 x ULN, biliary obstruction with hyperbilirubinemia (total bilirubin 2 x ULN)
4. Active cholecystitis, gall bladder symptoms, or any hepatobiliary
abnormalities
5. The presence of severe renal impairment (creatinine clearance [CrCl] 30 mL/min or creatinine 3 x ULN), nephrotic syndrome, or subjects undergoing dialysis
6. Uncontrolled diabetes mellitus (known hemoglobin A1c
[HbA1c] 11% within the last 1 month prior to Screening)
7. Females who are nursing, pregnant, or intend to become pregnant during the time of the study, or females of childbearing potential who have a positive pregnancy test during screening evaluation. Women of child-bearing potential must also use a reliable method of birth control during the study and for 1 month following completion of therapy. A reliable method for this study is defined as one of the following: oral or injectable contraceptives, intrauterine device (IUD), contraceptive implants, tubal ligation,
hysterectomy, a double barrier method (diaphragm with spermicidal foam or jelly, or a condom).
8. Subjects who have a history of alcohol or drug abuse within 1 year of study entry
9. Subjects living too far from participating center or unable to
return for follow-up visits
10. Subjects who in the opinion of the Investigator are a poor
medical or psychiatric risk for therapy with an investigational drug, are unreliable, or have an incomplete understanding of the study which may affect their ability to take drugs as prescribed or comply with instructions
11. Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), or tuberculosis infection
12. Acute bacterial, fungal or viral infection
13. Subjects currently taking drugs that are potent inhibitors of cytochrome P450 unless they can be withdrawn
14. Subjects with New York Heart Association (NYHA) Class III or IV heart failure, or if known, left ventricular ejection fraction (LVEF) 30%
15. Subjects with moderate or severe aortic stenosis, aortic regurgitation, mitral stenosis or mitral regurgitation
16. Ventricular arrhythmias requiring chronic drug treatment or
implantable cardioverter-defibrillator (ICD)
17. Subjects with no stenosis or stenosis 50% on angiography, if known
18. Subjects with a pacemaker or persistent left bundle branch block (LBBB)
19. Fasting triglyceride levels of more than or equal to 400mg/dL (4.5 mmol/L)
20. Subjects who have a history of statin intolerance or a significant myopathy or rhabdomyolysis with any lipidaltering drugs
21. Subjects currently treated with the maximum labeled dose of a statin and not at LDL-C target for their level of risk as defined by NCEP ATP 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine whether 16 weeks of treatment with A-002 plus atorvastatin and standard of care is superior to placebo plus atorvastatin and standard of care for reducing the hazard of the first occurrence of the combined endpoint of cardiovascular death, non fatal myocardial infarction, non-fatal stroke, or documented unstable angina with objective evidence of ischemia requiring hospitalization.  16 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To determine whether A-002 plus atorvastatin and standard of care is superior to placebo plus atorvastatin and standard of care for reducing the occurrence of the hazard of the combined endpoint of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, or documented unstable angina with objective evidence of ischemia requiring hospitalization, or multiple occurrences of the non-fatal components of the composite primary endpoint.  16 Weeks 
 
Target Sample Size   Total Sample Size="6500"
Sample Size from India="650" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   25/05/2011 
Date of First Enrollment (Global)  01/06/2010 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Other (Terminated) 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details    
Brief Summary   This is a double-blind, randomized, parallel group, placebo controlled study in subjects presenting with an ACS. Up to 6500 subjects will be randomized to receive either A-002 500 mg once daily (QD) or placebo tablets in addition to atorvastatin QD and standard of care. Treatment will be 16 weeks in duration. The dose of atorvastatin shall be adjusted after 8 weeks if LDL-C of subject is more than or equal to 100 mg/dL, but otherwise must remain stable throughout the16-week duration of study. The survival status for all enrolled subjects will be ascertained 6 months after they complete the study. Randomization must occur within less than or equal to 96 hours of hospitalization for the index ACS event, or if already hospitalized, within 96 hours of index event diagnosis. Follow-up visits occur at 1, 2, 4, 6, 24, 48, 72 and 96 and Weeks 1, 2, 4, 8 and 16. Randomization will be stratified by the presence or absence of lipid-altering therapy prior to the index event as well as the type of index event (admission diagnosis of unstable angina, NSTEMI or STEMI). The number of subjects who undergo PCI following the index event and prior to randomization will be limited to no more than 55% of the total study population. 
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