| CTRI Number |
CTRI/2024/11/077385 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Real-World Study on Factors Influencing Statin Dose Choice in Primary Cardiovascular Disease Prevention |
|
Scientific Title of Study
|
Real-world study to idEntify patient characteristics inFLuencing the choice of statin dosE in individuals for primary Cardiovascular disease prevenTion |
| Trial Acronym |
REFLECT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ING_CR_2024_C6, Version no.01, dated 01/09/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Kumar Das |
| Designation |
Consultant |
| Affiliation |
Cipla Limited |
| Address |
Cipla Limited
289 Bellasis Road
Mumbai Central
Mumbai
Maharashtra India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
|
| Fax |
|
| Email |
ashokdas82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandesh Sawant |
| Designation |
Vice President Head Clinical Trials |
| Affiliation |
Cipla Limited |
| Address |
Dept Medical Services
Division Clinical Trials
Room No NA 289
Bellasis Road Mumbai Central
Mumbai
Maharashtra India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223025006 |
| Fax |
|
| Email |
sandesh.sawant3@cipla.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Rahul Iyer |
| Designation |
Senior Manager Clinical Trials |
| Affiliation |
Cipla Limited |
| Address |
Cipla Ltd
Dept Medical Services
Division Clinical Trials
Room No NA
289 Bellasis Road
Mumbai Central
Mumbai Maharashtra India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223025623 |
| Fax |
|
| Email |
rahul.iyer@cipla.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Cipla Limited |
| Address |
Cipla Ltd 289
Bellasis Road Mumbai Central
Mumbai Maharashtra 400008 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashok Kumar Das |
Cipla Limited |
Cipla House Peninsula Business Department of Medical Affairs Park Ganapatrao Kadam Marg Lower Parel West Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA |
9003687234
ashokdas82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Suraksha-Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 80mg |
Single Visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
Single Visit |
|
|
Target Sample Size
|
Total Sample Size="15000"
Sample Size from India="15000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Statins are recognized as
the first-line therapy for dyslipidemia management and for cardiovascular risk
reduction. Major guidelines recommend use of statin therapy for both primary and
secondary prevention of cardiovascular diseases. Specifically for primary
cardiovascular disease prevention, the dose of statin depends on the assessment
of cardiovascular risk. The risk defines the dose of statin to be prescribed.
Evidence from India on the aspects that clinicians use to decide the dose of
statin is sparse. Thus, REFLECT study has been undertaken to identify patient
characteristics that influence the choice of statin dose in primary
cardiovascular disease prevention individuals in real world setting
The recruitment of
15,000 patients will be facilitated by 750 investigators across India. |