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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	CTRI
Last refreshed on:	24 November 2021
Main ID:	CTRI/2013/07/003804
Date of registration:	05-07-2013
Prospective Registration:	Yes
Primary sponsor:	Merck Co Inc
Public title:	Observational study to understand the profile of heart diseases and compare with other country
Scientific title:	Lipid target achievement in high risk patients with Coronary Heart Disease (DYSIS II ACS/CHD) - Dysis-II
Date of first enrolment:	10-07-2013
Target sample size:	10500
Recruitment status:	Completed
URL:	http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=6366
Study type:	Observational
Study design:	Other Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
Phase:	N/A

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

Contacts

Name:	Dr Samir Sadekar
Address:	Pacific Clinical Research India Pvt Ltd, 224, Bhaveshwar Arcade, Opp. Shreyas Cinema, L. B. S. Marg, Ghatkopar (W), Mumbai- 400 086, Maharashtra, India 400 086 Mumbai, MAHARASHTRA India
Telephone:	09930270041
Email:	ssadekar@pacificCRO.com
Affiliation:	Pacific Clinical Research India Pvt Ltd,

Name:	Dr Samir Sadekar
Address:	Pacific Clinical Research India Pvt Ltd, 224, Bhaveshwar Arcade, Opp. Shreyas Cinema, L. B. S. Marg, Ghatkopar (W), Mumbai- 400 086, Maharashtra, India 400 086 Mumbai, MAHARASHTRA India
Telephone:	09930270041
Email:	ssadekar@pacificCRO.com
Affiliation:	Pacific Clinical Research India Pvt Ltd,

Key inclusion & exclusion criteria

Inclusion criteria: 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
Exclusion criteria: 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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- -Age 18 years and above -Written informed consent for participation - Hospitalized for acute coronary syndrome -Prior angioplasty or Prior bypass surgery

Intervention(s)

Primary Outcome(s)

The primary objective of this observational study is to document real life lipid levels in patients with stable CHD (stable CHD or ACS)

Timepoint: 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(s)

â?¢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

â?¢To document drug utilization patterns for patients with CHD and among CHD subgroups (stable CHD, ACS, CKD, T2DM)

â?¢To document goal achievements in CHD patients and among CHD subgroups (stable CHD, ACS, CKD, T2DM), treated and not treated with lipid-modifying therapy.

Timepoint: â?¢ 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

â?¢ To document drug utilization patterns for patients with CHD and among CHD subgroups (stable CHD, ACS, CKD, T2DM)

â?¢ To document goal achievements in CHD patients and among CHD subgroups (stable CHD, ACS, CKD, T2DM), treated and not treated with lipid-modifying therapy.

Secondary ID(s)

NIL

Source(s) of Monetary Support

IMS Health Information and Consulting Services India Pvt. Ltd.

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 27/08/2012
Contact:

Central India Medical Research Ethics Committee

Status: Approved
Approval date: 03/06/2013
Contact:

Institutional Ethics Committee The Madras Medical Mission

Status: Approved
Approval date: 13/06/2013
Contact:

Bankers Ethics Committee

Status: Approved
Approval date: 27/06/2013
Contact:

Clinical Research Ethics Committee, Medica Superspecialty Hospital

Status: Approved
Approval date: 03/07/2013
Contact:

Institutional Ethics Committee, KIMS foundation and research center

Status: Approved
Approval date: 03/07/2013
Contact:

Institutional Human Ethical Committee

Status: Approved
Approval date: 06/07/2013
Contact:

Institutional Ethics Committee, Apollo Gleneagles Hospital Ltd

Status: Approved
Approval date: 06/07/2013
Contact:

KFRC Ethics committee

Status: Approved
Approval date: 18/07/2013
Contact:

Ethics Committee, PRS Hospital

Status: Approved
Approval date: 02/08/2013
Contact:

Medanta Institutional Ethics Committee

Status: Approved
Approval date: 05/08/2013
Contact:

Institutional Ethical Review Board, St. Johns Medical College Hospital

Status: Approved
Approval date: 19/08/2013
Contact:

Ethics Committee on Clinical Trials, Indraprashta Apollo Hospitals, New Delhi

Status: Approved
Approval date: 27/08/2013
Contact:

Central India Medical Research Ethics Committe, Nagpur

Status: Approved
Approval date: 27/08/2013
Contact:

Central India Medical Research Ethics Committee

Status: Approved
Approval date: 27/08/2013
Contact:

Central India Medical Research Ethics Committee, Nagpur

Status: Approved
Approval date: 27/08/2013
Contact:

Manav Health foundation INDEPENDENT ETHICS COMMITTE

Status: Approved
Approval date: 04/09/2013
Contact:

Sujlam Independent Ethics Committee

Status: Approved
Approval date: 06/09/2013
Contact:

Institutional Ethics Committee, Sir Ganga Ram Hospital

Status: Approved
Approval date: 11/09/2013
Contact:

M.S.Ramaiah Medical College and Hospitals, Ethical Review Board

Status: Approved
Approval date: 09/10/2013
Contact:

Narayana Hrudayalaya Medical Ethics Committee

Status: Approved
Approval date: 26/10/2013
Contact:

Medysis Clinisearch Ethical Review Board

Status: Approved
Approval date: 29/11/2013
Contact:

Nirmal HospitalPvt Ltd Ethics committee

Results

Results available:
Date Posted:
Date Completed:
URL:

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