CTRI/2013/07/003804 [Registered on: 05/07/2013] Trial Registered Prospectively
Last Modified On:
20/02/2015
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Prospective data Collection
Study Design
Other
Public Title of Study
Observational study to understand the profile of heart diseases and compare with other country
Scientific Title of Study
Lipid target achievement in high risk patients with Coronary Heart Disease (DYSIS II ACS/CHD)
Trial Acronym
Dysis-II
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Bankim Chauhan
Designation
Trial Coordinator
Affiliation
Pacific Clinical Research India Pvt. Ltd
Address
Pacific Clinical Research India Pvt Ltd,
224, Bhaveshwar Arcade, Opp. Shreyas Cinema,
L. B. S. Marg, Ghatkopar (W), Mumbai-
Mumbai (Suburban) MAHARASHTRA 400086 India
Phone
02225003224
Fax
02225003224
Email
bchauhan@pacificcro.com
Details of Contact Person Scientific Query
Name
Dr Samir Sadekar
Designation
Managing Director
Affiliation
Pacific Clinical Research India Pvt Ltd,
Address
Pacific Clinical Research India Pvt Ltd,
224, Bhaveshwar Arcade, Opp. Shreyas Cinema,
L. B. S. Marg, Ghatkopar (W), Mumbai- 400 086,
Maharashtra, India
Mumbai MAHARASHTRA 400 086 India
Phone
09930270041
Fax
02225003224
Email
ssadekar@pacificCRO.com
Details of Contact Person Public Query
Name
Dr Samir Sadekar
Designation
Affiliation
Pacific Clinical Research India Pvt Ltd,
Address
Pacific Clinical Research India Pvt Ltd,
224, Bhaveshwar Arcade, Opp. Shreyas Cinema,
L. B. S. Marg, Ghatkopar (W), Mumbai- 400 086,
Maharashtra, India
Mumbai MAHARASHTRA 400 086 India
Phone
09930270041
Fax
02225003224
Email
ssadekar@pacificCRO.com
Source of Monetary or Material Support
IMS Health Information and Consulting Services India Pvt. Ltd.
Primary Sponsor
Name
Merck Co Inc
Address
Merck & Co., Inc.
One Merck Drive
P.O. Box 100
Whitehouse Station NJ, 08889-0100, U.S.A.
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
Belgium Egypt France Germany Greece Hong Kong India Indonesia Ireland Italy Jordan Kuwait Lebanon Philippines Republic of Korea Russian Federation Saudi Arabia Singapore Taiwan Thailand United Arab Emirates Viet Nam
Apex Heart Institute (A Unit of TCVS Pvt. Ltd.)
Block : G-K, Mondeal Bussiness Park, Near Gurudwara, S.G. Highway, Ahmedabad - 380054, Gujarat, India. Ahmadabad GUJARAT
09824030576
drtpatel@yahoo.com
Dr Aftab Khan
Apollo Gleneagles Hospital, Kolkata
Apollo Gleneagles Hospital, Department of Cardiology and Electrophysiology services,
58, Canal Circular Road,
Kolkata-700054,
West Bengal, India. Kolkata WEST BENGAL
919831257844
cardiokhan@gmail.com
Dr Rajesh Gajara
Arogya Nurshing Home and ICU
consultant Cardiologist and Intensivist, Arogya Nurshing Home and ICU, corner of Bhakti Marg, Mulund West, Mumbai 400080, Maharashtra, India Mumbai (Suburban) MAHARASHTRA
09833594268
dr_gajra@yahoo.com
Dr Darshan Banker
Banker Heart Institute
Banker Heart Institute, Department of Cardiology,
Tagore nagar, Opp. Suryakiran Complex,
Old Padra Road, Vadodara 390 015,
Gujarat, India. Vadodara GUJARAT
912652324004
dnb@bankersheart.com
Dr Gulla Suryaprakash
Care Hospitals
Care Hospitals, Near Clock Tower, Market Street, Secunderabad-500003, Andhra Pradesh, India. Hyderabad ANDHRA PRADESH
09949350369
suryaprakashgulla@gmail.com
Dr BKS Sastry
Care Hospitals, Nampalli
CARE Nampally
Exhibition Grounds Road, Nampally, Hyderabad - 500001, India Hyderabad ANDHRA PRADESH
09849599888
bkssastry@hotmail.com
Dr Debabrata Roy
Consultant Interventional Cardiologist
Salt Lake, Tank No. 3, Kolkata 64. India Kolkata WEST BENGAL
0930341087
debroy67@ymail.com
Dr Jay Shah
HCG Medisurge Hospital
Medisurge Hospital, Near Mithakali Cross Road, Navrang pura, Ahmedabad-382481, Gujarat, India. Ahmadabad GUJARAT
09898209755
jayshah08@yahoo.co.in
Dr Rajeev Rajput
Indraprastha Apollo Hospital
Indraprastha Apollo Hospital, Sarita Vihar, Delhi- Mathura Road, New Delhi - 110076, India New Delhi DELHI
09810013417
rajeeve_kumar@hotmail.com
Dr G Vijayaraghavan
Kerala Institute of Medical sciences
Kerala Institute of Medical sciences, Department of cardiology,
Anyara PO, Trivandrum-695029,
Kerala, India. Thiruvananthapuram KERALA
919847060855
drgvijayaraghavan@gmail.com
Dr Dayasagar Rao
Krishna Institute of Medical Sciences
Krishna Institute of Medical Sciences, Department of Cardiology,
Foundation & Research Center,
1-8-31/1, Minister Road,
Secunderabad – 500003,
Andrapradesh, India. Hyderabad ANDHRA PRADESH
919849022989
drsvala@rediffmail.com
Dr Rajendra Kumar Premchand
Krishna Institute of Medical Sciences
Krishna Institute of Medical Sciences,1-8-31/1, Minister Road, Secunderabad - 500003, Andhra Pradesh, India.. Hyderabad ANDHRA PRADESH
09848029443
kumarpre@hotmail.com
Dr Nagmallesh
M S Ramaiah Narayana Hyrudayalaya Heart Center
New B E L Road, M S Ramaiah Nagar, MSRIT Post,
Bangalore - 560 054, Karnataka. Bangalore KARNATAKA
09880135258
nmalesh@yahoo.co.in
Dr Atul Abhaynakar
Mahavir Cardiac Center
Mahavir Cardiac Institute, Athwalines, Mahavir Gate,, Surat,Gujarat, India Surat GUJARAT
09824145738
atulda@hotmail.com
Dr Balbir Singh
Medanta The Medicity
Medanta The Medicity, Division of Electrophysiology,
Sec-38, Gurgaon-122001,
Haryana, India. Gurgaon HARYANA
919818898479
drbalbirs@gmail.com
Dr Sunip Banerjee
Medica Superspecialty Hospital
Medica Superspecialty Hospital, Medica Institute of Cardiac sciences department.
127, Mukundapur, Kolkata-700099,
West Bengal, India. Kolkata WEST BENGAL
919831257509
drsunip@yahoo.com
Dr Arup Dasbiswas
NRS Medical college & hospital
NRS Medical college and Hospital, Kolkata, 138 Acharya Jagadish Chandra Bose Road , Sealdah
Entally, Kolkata-700014, West Bengal,India Kolkata WEST BENGAL
09830022609
arup.dasbiswas@gmail.com
Dr Anil Jawahirani
Radiance Hospital
113-A, Quetta Colony, Near Telephone Exchange Square, Nagpur 440008, Maharashtra, India Nagpur MAHARASHTRA
09822220936
drartideo@gmail.com
Dr Mahesh Fulwani
Shrikrishna Hrudayalaya and Critical Care Centre
Shrikrishna Hrudayalaya and Critical Care Centre, Opposite New English School, Tikekar road, Congress Nagar Square, Dhantoli, Nagpur-440012, Maharashtra, India. Nagpur MAHARASHTRA
09823078146
maheshfulwani@yahoo.co.in
Dr JPS Sawhney
Sir Ganga Ram Hospital
Sir Ganga Ram Hospital, Department of Cardiology,
Sir Ganga Ram Hospital Marg,
Rajinder Nagar, Delhi-110060, India New Delhi DELHI
Central India Medical Research Ethics Committe, Nagpur
Approved
Central India Medical Research Ethics Committee
Approved
Central India Medical Research Ethics Committee
Approved
Central India Medical Research Ethics Committee
Approved
Central India Medical Research Ethics Committee, Nagpur
Approved
Central India Medical Research Ethics Committee, Nagpur
Approved
Central India Medical Research Ethics committee, Nagpur
Approved
Clinical Research Ethics Committee, Medica Superspecialty Hospital
Approved
Ethics Committee on Clinical Trials, Indraprashta Apollo Hospitals, New Delhi
Approved
Ethics Committee, PRS Hospital
Approved
Institutional Ethical Review Board, St. Johns Medical College Hospital
Approved
Institutional Ethics Committee The Madras Medical Mission
Approved
Institutional Ethics Committee, Apollo Gleneagles Hospital Ltd
Approved
Institutional Ethics Committee, KIMS foundation and research center
Approved
Institutional Ethics Committee, Sir Ganga Ram Hospital
Approved
Institutional Human Ethical Committee
Approved
KFRC Ethics committee
Approved
M.S.Ramaiah Medical College and Hospitals, Ethical Review Board
Approved
Manav Health foundation INDEPENDENT ETHICS COMMITTE
Approved
Medanta Institutional Ethics Committee
Approved
Medysis Clinisearch Ethical Review Board
Approved
Narayana Hrudayalaya Medical Ethics Committee
Approved
Nirmal HospitalPvt Ltd Ethics committee
Approved
Sujlam Independent Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
-Age 18 years and above
-Written informed consent for participation
- Hospitalized for acute coronary syndrome
-Prior angioplasty or Prior bypass surgery
,
Intervention / Comparator Agent
Type
Name
Details
Inclusion Criteria
Age From
18.00 Year(s)
Age To
85.00 Year(s)
Gender
Both
Details
DYSIS II ACS
• Age ≥ 18 years
• Hospitalized for acute coronary syndrome (ACS) (ST segment elevation myocardial infarction (STEMI), left bundle branch block (LBBB), Non-ST elevated myocardial infarction (NSTEMI), unstable angina) at time of enrolment
• Full lipid profile available based on blood drawn within 24 hours of admission to the hospital.
• On lipid-modifying therapy (LMT) for equal to or more than 3 months at time of enrolment, or NOT at all on LMT.
DYSIS II CHD
• Age ≥ 18 years
• Documented CHD by at least one of the following:
o coronary angiography (stenosis >50%)
o cardiac computed tomography (CT) (stenosis > 50%)
o prior percutaneous coronary intervention (PCI) or prior coronary artery bypass graft (CABG)
o history of ACS >3 months prior to enrolment
o Complete fasting lipid profile 0-12 months prior to enrollment while on lipid modifying therapy (LMT) for equal to or more than 3 months or not at all on LMT
ExclusionCriteria
Details
DYSIS II ACS
• Patients treated with lipid-modifying therapy for more than 0 but less than 3 months at the time of enrolment
DYSIS II CHD
• History of ACS within 3 months prior to enrollment
• Participation in DYSIS II ACS
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
The primary objective of this observational study is to document real life lipid levels in patients with stable CHD (stable CHD or ACS)
Time point for assessment for Stable CHD is when patient report or visit to treating physician for routine follow-up
Time Point for Data collection of ACS patients - When patient is discharged after successful ACS treatment. Thereafter telephonic follow-up 16 weeks post discharge
Secondary Outcome
Outcome
TimePoints
•To describe patient characteristics and risk profiles (associated comorbidities) in patients with stable CHD specifically chronic kidney disease (CKD stages 3-5) and type 2 diabetes mellitus (T2DM) and survivors of ACS
•To document drug utilization patterns for patients with CHD and among CHD subgroups (stable CHD, ACS, CKD, T2DM)
•To document goal achievements in CHD patients and among CHD subgroups (stable CHD, ACS, CKD, T2DM), treated and not treated with lipid-modifying therapy.
• To describe patient characteristics and risk profiles (associated comorbidities) in patients with stable CHD specifically chronic kidney disease (CKD stages 3-5) and type 2 diabetes mellitus (T2DM) and survivors of ACS
• To document drug utilization patterns for patients with CHD and among CHD subgroups (stable CHD, ACS, CKD, T2DM)
• To document goal achievements in CHD patients and among CHD subgroups (stable CHD, ACS, CKD, T2DM), treated and not treated with lipid-modifying therapy.
Target Sample Size
Total Sample Size="10500" Sample Size from India="1000" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
As this study is part of multi center study, publications derived from this study will include input from the investigators and the team of international sponsor Merck USA.
Such input should be reflected in publication authorship, and wherever possible, preliminary agreement regarding the strategy for order of authors names should be established before conducting the study analysis.
Subsequent to the multi center publication, or 18 months after completion of the study, whichever comes first, an investigator may publish the results for their study site independently. However, sponsor do not recommend separate publication of individual study site for scientific reasons or concerns.
Also, Merck must an opportunity to review all proposed abstracts, manuscripts and or presentations regarding this study at least 10 business days prior to submission for publication or presentations.
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Patients with
coronary heart disease (CHD) are considered to be at very high risk for
subsequent adverse cardiovascular events. Long-term treatment of cardiovascular
risk factors such as hyperlipidemia, hypertension as well as diabetes are key
factors to avoid the progress of CHD and its complications.
Data on
treatment for secondary prevention in clinical practice was first provided by
the EuroAspire Survey as part of the Euro Heart Survey program showing an
improvement of guideline adherence over time, however, with evident room for
improvement. The 2L-Registry conducted in Germany documented large deficiencies
in the lipid lowering treatment for secondary prevention in the hospital as
well as in the outpatient setting (Gitt et al., Clin Res Cardiol. 2011 Apr;100
(4):277-87 and Gitt et al., Eur J Cardiovasc Prev Rehabil. 2009
Aug;16(4):438-44).
The
management of ACS has been rapidly evolving during the past few decades. The
introduction of primary PCI as well as advanced anti-thrombotic and
anti-platelet treatments resulted in a significant improvement of acute outcome
in these patients. However, patients surviving an ACS will continue to be at
high risk for subsequent events.
In 2011, the European
Society of Cardiology (ESC) and the European Artherosclerosis Society (EAS)
published new guidelines for the management of dyslipidemias (European Heart
Journal (2011) 32, 1769–1818) acknowledging data from recent randomized trials.
These new guidelines set the target for LDL-cholesterol to <70mg/dl for
patients with CHD.
DYSIS II will
document the lipid target achievements and the prevalence of dyslipidemias in
patients with stable CHD and in patients surviving any ACS regardless of
whether they are treated with lipid-modifying therapy or not. the proposed
DYSYS-II (ACS/CHD) is purely observational study wherein NO treatment will be
given to patients / or NO medical procedures would be undertaken.
The study does not recommend or discourage any treatments, procedures,
diagnostics or examinations in routine patient care management.