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Observational study to understand the profile of heart diseases and compare with other country

Lipid target achievement in high risk patients with Coronary Heart Disease (DYSIS II ACS/CHD) - Dysis-II

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2013/07/003804
Enrollment
10500
Registered
2013-07-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Sponsors

Merck Co Inc
Lead Sponsor

Eligibility

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

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

Public ContactDr Samir Sadekar

Pacific Clinical Research India Pvt Ltd,

ssadekar@pacificCRO.com09930270041

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026