Official Registry Synopsis

INDIA-STATIN-PCI Registry

Real-World Use, Adherence, and Outcomes of High-Dose Atorvastatin Therapy in ACS Patients Undergoing PCI in India.

2,000
Target Patients
20
Sites Across India

The Burden of ACS in India

India bears one of the world's largest burdens of Acute Coronary Syndrome (ACS). While global guidelines advocate for high-intensity statin therapy, real-world data regarding adherence and outcomes specifically within the Indian population is scarce. This registry fills this critical evidence gap.

Lipid Control Gap (Baseline Estimation)

Extremely High-Risk PCI Patients

Current estimated percentage of ACS patients who underwent PCI in India achieving aggressive LDL-C targets (pre-registry).

1st → 2nd LDL
32.7%
Reduction (pre-registry)
2nd → 3rd LDL
12.3%
Reduction (pre-registry)
1st → 3rd LDL
41.0%
Reduction (pre-registry)
1

High Morbidity

ACS is a leading cause of mortality. Younger onset age in Indians requires aggressive secondary prevention.

2

Guideline vs. Practice

ACC/AHA 2025 and ESC guidelines mandate high-intensity statins post PCI. We need to measure how often this is prescribed and tolerated.

3

Outcomes

This registry stratifies the clinical outcomes segmented by socioeconomic, regional, and practice-type factors.

Study Design & Workflow

A prospective, multicenter observational registry across 20 sites. The workflow emphasizes capturing data at critical transition points of care: Admission, Discharge, and Follow-up (1, 3, and 6 months).

🏥

Hospital Admission

Screening & Consent.

Index Event: ACS
🩺

Intervention (PCI)

Primary or Elective PCI.

Start High-Intensity Atorvastatin
📄

Discharge

Education & Prescription.

Baseline Lipid Profile
📞

Follow-Up

1, 3, & 6 Months.

Adherence & MACE Check

Core Objectives

Primary Objective

Characterize real-world care and outcomes. Specifically tracking hospital readmissions and revascularization procedures within the first 6 months, particularly in the first 90 days post-PCI.

Adherence & Persistence

Assess adherence to High-Dose Atorvastatin using standardized queries. Identify reasons for discontinuation.

Lipid Goals

Evaluate the proportion of patients achieving guideline-directed LDL-C targets at the 6-month mark post-PCI.

Anticipated Barriers to High Dose Statin Adherence (Illustrative)

Illustrative distribution of anticipated barriers to high-dose statin adherence in the Indian real-world setting.

Site Stratification

Target distribution of participating centers. Five centres from each region, primarily involving Heads of Cardiology Divisions. Mix of corporate chain hospitals, standalone private hospitals, private medical institutions, and public hospitals/medical colleges.

Projected LDL-C Trajectory

Illustrative pre-registry model of LDL-C response for ACS patients on high-intensity Atorvastatin, from baseline to 6 months. Values shown are simulated placeholders and will be updated once registry data are available.

Project Timeline

1

Month 0–3

Site selection, ethics committee approvals, and staff training.

2

Months 4–12

Active patient enrollment (Target: 200+ patients/month).

3

Months 13–20

Active follow-up (6 months per patient).

4

Months 3–20

Data QC, query resolution, and monthly reports.

5

Months 21–22

Statistical analysis and insights.

6

Months 23–24

Abstracts, manuscripts, and submissions.