| CTRI Number |
CTRI/2010/091/002926 [Registered on: 23/11/2010] |
| Last Modified On: |
22/02/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
Modification(s)
|
Study to demonstrate the safety and effects of GW856553 on inflammatory markers, infarct size and cardiac Function in subjects with myocardial infarction without ST segment elevation. |
Scientific Title of Study
Modification(s)
|
A randomized, double-blind, placebo-controlled study to evaluate the safety of 12 weeks of dosing with GW856553 and its effects on inflammatory markers, infarct size, and cardiac function in subjects with myocardial infarction without ST segment elevation |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT00910962 |
ClinicalTrials.gov |
| PM1111810 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Srikant KV |
| Designation |
Principal Investigator |
| Affiliation |
|
| Address |
Bhagwan Mahaveer Jain heart centre,
Miller’s road, Vasanthnagar,
Bangalore
Bangalore
KARNATAKA
560052
India |
| Phone |
08041999300 |
| Fax |
|
| Email |
srikanth_kv@rediffmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Anand Eshwariah |
| Designation |
|
| Affiliation |
|
| Address |
Clinigene International Limited
Hosur Road, Tower 1, Phase II, Electronics city, Bangalore
Bangalore
KARNATAKA
560100
India |
| Phone |
08028082728 |
| Fax |
|
| Email |
Anand.Eswaraiah@clinigeneintl.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Anand Eshwariah |
| Designation |
|
| Affiliation |
|
| Address |
Clinigene International Limited
Hosur Road, Tower 1, Phase II, Electronics city, Bangalore
Bangalore
KARNATAKA
560100
India |
| Phone |
08028082728 |
| Fax |
|
| Email |
Anand.Eswaraiah@clinigeneintl.com |
|
Source of Monetary or Material Support
Modification(s)
|
| GlaxoSmithKline Research & Development Limited
980 Great West Road
Brentford
Middlesex, TW8 9GS
UK
|
|
Primary Sponsor
Modification(s)
|
| Name |
GlaxoSmithKline Research Development Limited |
| Address |
980 Great West Road, Brentford, Middlesex, TW8 9,GS, UK. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Clinigene International Ltd |
Tower I, Semicon Park, Electronics City, Phase II, Hosur Road, Bangalore 560 100, India |
|
Countries of Recruitment
Modification(s)
|
India
Australia
Canada
Germany
Netherlands
Spain
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh S S |
Bhagwan Mahaveer Jain heart centre |
Bhagwan Mahaveer Jain heart centre, Millers road,Vasanthnagar,Bangalore
Bangalore
KARNATAKA |
080-41999329
080-41538708
ssramesh@vivushealth.net |
| Dr Keyur Parikh |
Care Institute of Medical Sciences |
Care Institute of Medical Sciences, Off Science City Road,Near Shukan Mall, Sola, Ahmedabad- 380060
Ahmadabad
GUJARAT |
079-27712771
keyur.parikh@heartcareclinic.org |
| Dr Kulkarni Ravindra Laxman |
Deendayal Memorial Hospital |
Deendayal Memorial Hospital, 926, F.C. Road, Shivaji Nagar,Pune-411004
Pune
MAHARASHTRA |
02025652497
drravindrakulkarni@gmail.com |
| Dr VS Prakash |
M.S. Ramaiah Narayana Hrudayalaya Heart Center |
Professor & Head department of Cardiology,
M.S. Ramaiah Narayana Hrudayalaya Heart Center,
Gokula Metropolis Clinical Research Center,
MSR Hospital,
MSRIT Post, New BEL Road
Bangalore- 560054
Bangalore
KARNATAKA |
9844033964
drprakashvs@gmail.com |
| Dr Sanjay Mehrotra |
Narayana Hrudayalaya Hospital, |
Dept. of Cardiology
Narayana Hrudayalaya Hospital,
258/A, Bommasandra Industrial Area,
Anekal Taluk,
Bangalore-560099
Bangalore
KARNATAKA |
08027835000
sanjay.m@gmail.com |
| Dr KPBalakrishnan |
PVS Hospital Pvt Ltd |
Consultant Interventional Cardiologist
PVS Hospital Pvt Ltd
Railway Station Road
Calicut, Kerala
Pin -673002
Kozhikode
KERALA |
0495-2705045
pvscalicut.cr@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethical Review Board M.S Ramaiah Medical College And Teaching Hospital, MSR Nagar |
Approved |
| Ethics Committee of Care Institute of Medical Sciences |
Approved |
| Institutional Review Board, Cardiac Research Academy & Srinivasa Cardiology Centre Pvt Ltd |
Approved |
| Medical Ethics Committee Narayana Hrudayalaya Hospitals |
Approved |
| Penta-Med Ethics Committee |
Approved |
| PVS Hospital Pvt Ltd |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Subjects with myocardial infarction without ST segment elevation, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
GW856553X |
7.5 mg and 15 mg |
| Comparator Agent |
Placebo |
7.5 mg and 15 mg |
|
Inclusion Criteria
Modification(s)
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with a NSTEMI, defined as:
? symptoms (e.g. chest pain, dyspnea) consistent with acute coronary syndrome, lasting at least 10 minutes, with most recent symptoms occurring within the 24 hours prior to presentation,
? without persistent ST-segment elevation on admission 12-lead ECG, and
? with Troponin (T or I) above the upper limit of normal (ULN) for the local institution within 18 hours of presentation.
2. Subject able to be randomized within 18 hours of presentation.
3. Male or female subject who is 45 - 65 years of age, inclusive.
4. QTcB or QTcF ≤ 530 msec
|
|
| ExclusionCriteria |
| Details |
1. History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction [ejection fraction (EF) < 30%] regardless of symptomatic status.
2. Suspected aortic dissection, Severe aortic stenosis or other severe valvular disease.
3. Current known life-threatening condition other than vascular disease (e.g. severe chronic airways disease) that may prevent a subject from completing the study.
4. Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with active chronic or acute inflammation (e.g. inflammatory bowel disease, osteomyelitis, pneumonia, sepsis etc.). Intermittent conditions treated with short-term oral antibiotics (e.g. typical URI), or conditions that are not currently exacerbated (e.g. gout with no current flair) may be included.
5. History of myopathy or rhabdomyolysis.
6. Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
7. Known to be Hepatitis B or Hepatitis C positive.
8. Current or anticipated use of systemic steroids (oral or IV). Inhaled, intranasal and topical steroids are allowed. A single prophylactic dose of systemic steroid is allowed at time of PCI for subjects with contrast allergy.
9. Current or anticipated use of BCRP substrates with a narrow therapeutic index
10. Previously diagnosed cancer that has not been in complete remission for at least 5 years. Localized carcinomas of the skin and carcinoma in situ of the cervix that havebeen resected or ablated for cure are not exclusionary.
11. Known alcohol or drug abuse within the past 6 months.
12. Previous exposure to GW856553
|
|
Method of Generating Random Sequence
Modification(s)
|
Other |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To assess the safety of GW856553 in subjects with NSTEMI.
To assess the effects of GW856553 on biomarkers of inflammation in subjects with NSTEMI over the 12 weeks of treatment.
To assess the effects of GW856553 on infarct size and cardiac function during the peri-infarct period and during the ensuing 12 weeks of treatment
|
Inflammatory Endpoints
Primary
hsCRP at Week 12
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
hsCRP over hospitalization period and through Week 14
|
IL-6 at 24 hours post-randomization and at Weeks 2 and 12 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="552"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
17/01/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
08/10/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study is being conducted to evaluate the effects of GW856553X (where X indicates free base) in subjects with non-ST segment elevation myocardial infarction (NSTEMI). The primary objectives are assessments of safety, inflammatory markers and infarct size. Up to approximately 500 subjects will be randomized to ensure up to ~400 evaluable subjects complete 12 weeks of dosing. All subjects will continue to receive the local standard of care for the duration. Subjects will be assigned to:7.5 mg GW856553 starting dose, followed 12 (± 4) hours later by 7.5 mg BID GW856553 OR 15 mg GW856553 starting dose, followed 12 (± 4) hours later by 7.5 mg BID GW856553 OR placebo in the ration of 3:3:2. |