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 the world's largest burden of Acute Coronary Syndrome (ACS). While global guidelines advocate for high-intensity statin therapy (Atorvastatin 80mg), real-world data regarding adherence and outcomes specifically within the Indian demographic is scarce. This registry fills a critical evidence gap.

Lipid Control Gap (Baseline Estimation)

Current estimated percentage of ACS patients in India achieving aggressive LDL-C targets (<55 mg/dL) 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 guidelines mandate high-intensity statins. We need to measure how often this is prescribed and tolerated in Tier 2/3 Indian cities.

3

Socioeconomic Barriers

Cost and access significantly impact adherence. This registry specifically tracks "Out of Pocket" expenditure and medication persistence.

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 Atorvastatin 40-80mg
📄

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.

Adherence & Persistence

Assess adherence to High-Dose Atorvastatin using standardized queries. Identify reasons for discontinuation (Cost, Side effects, Physician advice).

Lipid Goals

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

Anticipated Barriers to Adherence

Projected distribution of reasons for statin discontinuation in the Indian real-world setting.

Site Stratification

Target distribution of participating centers to ensure rural and semi-urban representation.

Projected LDL-C Trajectory

Target therapeutic response curve for patients on Atorvastatin 80mg from Baseline to 6 Months.

Project Timeline

1

Months 1-3

Site selection, ethics committee approvals, and staff training.

2

Months 4-21

Active Patient Enrollment (Target: ~110 patients/month).

3

Month 28+

Data cleaning, analysis, manuscript preparation, and dissemination.