| CTRI Number |
CTRI/2013/02/003429 [Registered on: 25/02/2013] Trial Registered Retrospectively |
| Last Modified On: |
28/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Statins on Lipid Levels Following the First Acute Coronary Event (MK-0000-204) |
|
Scientific Title of Study
|
Dyslipidemia: REsidual and Mixed Abnormalities IN spite of Statin therapy: The Dyslipidemia REMAINS Study: A multicenter, prospective, observational study of lipid profiles and treatment patterns at presentation and after 12 weeks of statin therapy among Indian adults presenting with first coronary event |
| Trial Acronym |
REMAINS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MK-0000-204-00 |
Protocol Number |
| NCT01245738 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srinivasa Rao Maddury |
| Designation |
Senior Consultant Cardiologist |
| Affiliation |
Care Hospital Nampally |
| Address |
Care Hospital Nampally, Exhibition Road
Hyderabad
ANDHRA PRADESH
5000001
India |
| Phone |
040-30417777 |
| Fax |
|
| Email |
maddurysrinivas@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
DrViraj Salgoankar |
| Designation |
Director Medical Affairs |
| Affiliation |
MSD Pharmaceuticals Pvt. Ltd. |
| Address |
MSD Pharmaceuticals Pvt Ltd
Platina Building, 10th Floor
C-59, G-Block,
Bandra Kurla Complex
Bandra (East)
Mumbai 400098, India
Mumbai
MAHARASHTRA
400098
India |
| Phone |
91-22-6789-8888 |
| Fax |
91-22-67898889 |
| Email |
viraj.salgaonkar@merck.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Viraj Salgoankar |
| Designation |
Director Medical Affairs |
| Affiliation |
MSD Pharmaceuticals Pvt.Ltd. |
| Address |
MSD Pharmaceuticals Pvt Ltd
Platina Building, 10th Floor
C-59, G-Block,
Bandra Kurla Complex
Bandra (East)
Mumbai 400098, India
Mumbai
MAHARASHTRA
400098
India |
| Phone |
91-22-6789-8888 |
| Fax |
91-22-67898889 |
| Email |
viraj.salgaonkar@merck.com |
|
|
Source of Monetary or Material Support
|
| Merck & Co., Inc.
One Merck Drive
P.O. Box 100
Whitehouse Station, NJ 08889-0100 USA |
|
|
Primary Sponsor
|
| Name |
Merck Sharp and Dohme |
| Address |
One Merck Drive P.O. Box 100 Whitehouse Station, NJ 08889-0100 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 20 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pramod Kumar Dhar |
Apollo DRDO Hospital |
DMRL X Roads Kanchanbagh
Hyderabad
Hyderabad
ANDHRA PRADESH |
9177471112
pramodkumardhar@yahoo.com |
| Dr DIBYA KUMAR BARUAH |
Apollo Hospitals |
Waltair Main Road
Visakhpatnam
Visakhapatnam
ANDHRA PRADESH |
0891-2727272
0891-2560858
drdibyakumar_b@apollohospital.com |
| Dr P Ramachandran |
Apollo Hospitals Educational and Research Foundation (AHERF) |
Room No 16 & 17 , 2nd Floor, Krishnadeep Chambers,
Apollo Annexe No: 1, Wallace Garden Street, Thousand Lights
Chennai
Chennai
TAMIL NADU |
91-44-28294735
christine.j@aherf-smo.org |
| Dr Srinivasa Rao Maddury |
Care Hospital Nampally |
Exhibition Road, Nampally, Hyderabad
Hyderabad
ANDHRA PRADESH |
9866556662
maddurysrinivas@hotmail.com |
| Dr Milan Chug |
Care Institute of Medical Sciences |
Nr.Shukan Mall,
Off Science City Road,
Sola,
Ahmadabad
Ahmadabad
GUJARAT |
09824022107
milan.chag@heartcareclinic.org |
| Dr Gaurav Manocha |
Crosslay Remedies Limited |
W-3, Sector-1, Vaishali
Ghaziabad
Ghaziabad
UTTAR PRADESH |
0120-4188000
gminocha27@yahoo.co.in |
| Dr Soumitra Kumar |
Department of Medicine (Cardiology Division) Vivekananda Institute of Medical Sciences |
Ramakrishna Mission Seva Pratishthan
99, Sarat Bose Road
Kolkata
WEST BENGAL |
919831032519
drsk777@bsnl.in |
| Dr JPS Sawhney |
Dharamveer Heart Centre |
5th Floor, Sir Gangaram Hospital, Old Rajinder
New Delhi
DELHI |
9999668191
jpssawhney@yahoo.com |
| Dr Rajeev Gupta |
Fortis Escorts Hospital |
Jawaharlal Nehru Marg, Malviya Nagar
Jaipur
RAJASTHAN |
9829114086
rajeevgg@gmail.com |
| Dr Upendra Kaul |
Fortis Healthcare Limited Escorts Heart Institute & Research Center |
Okhla Road, New Delhi
New Delhi
DELHI |
01126825112
harpreetanand.kaur@gmail.com |
| Dr Rajpal k Abhaichand |
G Kuppuswamy Naidu Memorial Hospital |
PN Palayam
Coimbatore
Coimbatore
TAMIL NADU |
9791508740
rajtrials@yahoo.com |
| Dr Prabhat Kumar |
Heart Hospital |
Chandralaya Kankarbagh,
Near Central school
Patna
Patna
BIHAR |
0612-2356126
hhplpat@gmail.com |
| Dr Ajit Mullasari |
Institute of Cardiovascular Disease Madras Medical Mission hospital |
4-A,Dr. J.J Nagar,
Mogappair,
Chennai
Chennai
TAMIL NADU |
044-26565961
clireco@gmail.com |
| Dr Jamshed Dallal |
Kokilaben Dhirubhai Ambani Hospital & |
Four Bungalows,
Andheri(W), Mumbai
Mumbai
MAHARASHTRA |
09320199122
Medicalresearch.Kh@relianceada.com |
| Dr Sameer Dani |
Life Care hospitals |
303, Sardar Patel Statue Corner
Stadium Road,
Naranpura,
Ahmedabad
Ahmadabad
GUJARAT |
09824312300
danisameer@hotmail.com |
| Dr Ravi R Kasliwal |
Medanta-The Medicity |
Medanta-The Medicity, Sec-38
Gurgaon
HARYANA |
9971025827
rr.kasliwal@medanta.org |
| Dr Tiny Nair |
PRS Hospital |
Killipalam, Trivandrum
Thiruvananthapuram
KERALA |
9048229979
tinynair@gmail.com |
| Dr Rajesh M Binayala |
Sanjeevani Multispecialty Hospital |
Bhavani chambers
Kedarmal Road, Off Rani Sati Marg
Malad (East)
Mumbai
Mumbai
MAHARASHTRA |
9821148934
rajesh.binyala@sanjeevanihospital.com |
| Dr Mardikar Harshavardhan |
Spandan Heart Institute and Research Center |
31, Off Chitale Marg, Behind Hitavada Press, Dhantoli
Nagpur
MAHARASHTRA |
07122458009
drmardikar@rediffmail.com |
| Dr Rang Nath Nayak |
Vikram Hospital |
# 71/1, Millers Road
Bangalore
Bangalore
KARNATAKA |
9900075241
research.cardiology@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 20 |
| Name of Committee |
Approval Status |
| Clinical Ethics Forum_Dr. Binayala |
Approved |
| EC Apollo Hospitals |
Approved |
| EC Apollo Hospitals |
Approved |
| EC of Care Institute of Medical Sciences |
Approved |
| Escorts Heart Institute and Research Centre |
Approved |
| Ethical Committee, Ramakrishna Mission Seva Pratishthan |
Approved |
| Ethical Committee, Spandan Heart Institute and Research Centre |
Approved |
| Ethics Committee, PRS Hospital |
Approved |
| Ethics Committee, Sir Gangaram Hospital |
Approved |
| G. Kuppuswamy naidu Memorial Hospital |
Approved |
| I.E.C. Consultants |
Approved |
| IEC of CAre Foundation |
Approved |
| IEC of Pushpanjali Crosslay Hospital |
Approved |
| Institutional Ethical Committee, Care Hospital |
Approved |
| Institutional Ethics Committee, Fortis Escorts Hospital |
Approved |
| Institutional Review Board, Medanta-The Medicity |
Approved |
| Institutional Scientific and Ethics Board, K0kilaben Dhirubhai Ambani Hospital |
Approved |
| Life Care Institute of Medical Science and Research |
Approved |
| Madras Medical Mission EC |
Approved |
| Ramakrishna Mission Seva Paristhan VIMS_Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Dyslipidemia, (1) ICD-10 Condition: E781||Pure hyperglyceridemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Statin |
Any Statin Added or Adjusted by a Physician per Drug Label to Be Taken for at Least 12 Weeks |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
- Currently admitted with a confirmed diagnosis of first acute coronary event
(STEMI/NSTEMI/Unstable Angina).
- Access to medical records covering the entire study period, and availability of data
required for the study
- Potential to collect blood sample within 24 hours of onset for symptoms.
- Considered for initiation/maintenance/modification of statin therapy before discharge
from hospital.
- Willing to comply with the study requirements. |
|
| ExclusionCriteria |
| Details |
- Patients who are already participating in a clinical trial or any type of other clinical study involving therapeutic intervention or otherwise failing to consent to interview
- Patients with known inherited disorder of lipoprotein metabolism
- Patients with history of hypothyroidism, nephrotic syndrome, chronic alcoholism, Cushing syndrome |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total Cholesterol (TC) levels at First Acute Coronary Event |
At hospital presentation (Day 1) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Low-Density Lipoprotein Cholesterol (LDLC) levels at First Acute Coronary Event |
At hospital presentation (Day 1) |
|
|
Target Sample Size
|
Total Sample Size="850"
Sample Size from India="850"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The current study is proposed to investigate the pattern of dyslipidemia and of lipid treatment
practices in patients experiencing first acute cardiovascular event and the extent of residual
dyslipidemia after 12 weeks of treatment with statins. |