Skip to content

Real-World Study on Factors Influencing Statin Dose Choice in Primary Cardiovascular Disease Prevention

Real-world study to idEntify patient characteristics inFLuencing the choice of statin dosE in individuals for primary Cardiovascular disease prevenTion - REFLECT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/11/077385
Enrollment
15000
Registered
2024-11-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: E785- Hyperlipidemia, unspecified

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Cipla Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Primary CVD prevention patients ie patients with no history of atherosclerotic cardiovascular disease CVD but with risk factors for developing CVD as assessed from the clinical history documentation of the patient Patients who are initiated on a statin rosuvastatin or atorvastatin within the last 6 months as per the clinical judgement of the treating physician and are continuing the same dose or and require a dose modification as per clinical judgement of the treating physician in the current visit and Patients who are willing to provide informed written consent and agree to comply with the study procedures

Exclusion criteria

Exclusion criteria: Patients with known history of hypersensitivity eg anaphylaxis or angioedema to any component active and any excipients of the prescribed product rosuvastatin or atorvastatin Women who are pregnant or breastfeeding during study period Patients with acute liver failure or decompensated cirrhosis Patients who are participating in another clinical study

Design outcomes

Primary

MeasureTime frame
To identify characteristics of primary CVD prevention patients ie those who do not have a history of atherosclerotic CVD as per the dose of statins rosuvastatin 5mg or 10mg or 20mg or 40mg and atorvastatin 10mg or 20mg or 40mg or 80mgTimepoint: Single Visit

Secondary

MeasureTime frame
To analyse the association between the LDL C levels with dose of statin rosuvastatin or atorvastatin in patients already initiated on a statin rosuvastatin or atorvastatin To identify the risk factor/s that resulted in change in treatment decision in patients who were recommended a dose modification of statin rosuvastatin or atorvastatin in the current visit Compare the intensity of statin rosuvastatin or atorvastatin recommended as per ACC CV risk calculator with that observed actual clinical practice Timepoint: Single Visit

Countries

India

Contacts

Public ContactMr Rahul Iyer

Cipla Limited

sandesh.sawant3@cipla.com02223025006

Outcome results

None listed

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