FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/086581 [Registered on: 08/05/2025] Trial Registered Prospectively
Last Modified On: 05/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Studying the Effect of Rosuvastatin in Patients with Early Signs of Artery Narrowing (Atherosclerosis) - ROSE Trial  
Scientific Title of Study   A Prospective, Randomized, Parallel, Double-Blind, Clinical Trial to Assess the Efficacy of Rosuvastatin in Subclinical Atherosclerosis Patients (Rose Trial) 
Trial Acronym  ROSE Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sarita Rao 
Designation  Senior Interventional Cardiologist and Director Cathlab 
Affiliation  Apollo Rajshree Hospitals Indore 
Address  Apollo Rajshree Hospitals, Indore Scheme No. 74 C, Sector D, Vijay Nagar, Indore, Madhya Pradesh

Indore
MADHYA PRADESH
452010
India 
Phone  8959907706  
Fax    
Email  712740@apollohospitals.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Roshan Rao 
Designation  Senior Interventional Cardiologist and Head 
Affiliation  Apollo Rajshree Hospitals Indore 
Address  Apollo Rajshree Hospitals, Indore Scheme No. 74 C, Sector D, Vijay Nagar, Indore, Madhya Pradesh

Indore
MADHYA PRADESH
452010
India 
Phone  8959907707  
Fax    
Email  drroshanrao@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Achukatla Kumar 
Designation  Senior Research Consultant 
Affiliation  Apollo Rajshree Hospitals Indore 
Address  Apollo Rajshree Hospitals, Indore Scheme No. 74 C, Sector D, Vijay Nagar, Indore, Madhya Pradesh

Indore
MADHYA PRADESH
452010
India 
Phone  8247219324  
Fax    
Email  dr.achukatlakumar@gmail.com  
 
Source of Monetary or Material Support  
USV Private Limited Arvind Vithal Gandhi Chowk, BSD Marg, Station Road, Govandi East, Mumbai - 400 088. India. 
 
Primary Sponsor  
Name  USV Private Limited 
Address  Arvind Vithal Gandhi Chowk, BSD Marg, Station Road, Govandi East, Mumbai - 400 088. India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sarita Rao  Apollo Rajshree Hospitals Indore  Sector-D, Scheme No 74C, Vijay Nagar, Indore, Madhya Pradesh 452010
Indore
MADHYA PRADESH 		 8959907706

712740@apollohospitals.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Clinical Studies - Apollo Rajshree Hospitals Indore   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I708||Atherosclerosis of other arteries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Rosuvastatin  20 mg, OD, 6 months 
Comparator Agent  Standard of Care  Rosuvastatin will not be provided in this arm 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Males and females between 30 and 75 years of age capable and willing to provide informed consent
2.Participant with sub-clinical atherosclerosis (mild to moderate) defined as plaque visible on Carotid Doppler and causing less than 70% luminal stenosis, and CIMT less than 0.9 mm.
3.Fasting LDL C of greater than or equal to 100 mg/dL (3.1 mmol/L), Triglycerides less than 500 mg/dL (5.65 mmol/L), HDL-C levels less than or equal to 60 mg/dL (1.6 mmol/L) 
 
ExclusionCriteria 
Details  1.Participant with a history of cardiovascular disease, defined by a diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease
2.Participant with a history of Liver disease (cirrhosis, active hepatitis, or severe hepatic disease) or any of the following recent lab results and determined to be non-transient: alanine aminotransferase greater than 3 times the upper limit of normal or total bilirubin greater than 2 times the upper limit of normal (unless due to Gilbert syndrome)
3.Uncontrolled hypertension defined as either a mean resting diastolic blood pressure of greater than or equal to 110 mmHg or a resting systolic blood pressure of greater than or equal to 180 mmHg recorded at any time during the screening period
4.Diabetes patients
5.Thyroid replacement therapy
6.History of familial hypercholesterolemia

7.Participant with estimated glomerular filtration rate less than 60 mL/min/1.73 m2 or creatinine greater than 2 times the upper limit of normal
8.Patient with a history of an allergic reaction or significant sensitivity to statins
9.Patient currently taking LDL cholesterol lowering or anti-inflammatory medications including colchicine
10.Participants requiring regular drugs known to be potent CY2P inhibitors (eg. ketoconazole, clarithromycin)
11.A female patient who is pregnant, breast-feeding or considering becoming pregnant during the study
12.Participant with BMI greater than or equal to 40 kg/m2 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Change in Carotid Intima-Media Thickness (CIMT) Measurements: Ultrasonography will assess CIMT, reported in millimeters (mm) compared to treatment arm and Standard of Care.
2.Change in Plaque Volume: Carotid Doppler will be employed to measure plaque volume, reported in cubic millimeters (mm³).
3.Change in Maximal Luminal Stenosis: The maximal luminal stenosis, expressed as a percentage, will be assessed to determine the degree of coronary artery narrowing using Carotid doppler.
4.Change in Peak Systolic Velocity: Ultrasonography 		 0 and 6 Months (Pre and Post Intervention) 
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in lipid profile such as LDL-C, HDL-C, and Triglyceride Levels
2.Change in High-sensitivity C-Reactive Protein (hs-CRP) levels
3.Change in Calcium score levels 		 0 and 6 Months (Pre and Post Intervention) 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   20/05/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [saritarosh@yahoo.com].

  6. For how long will this data be available start date provided 01-06-2026 and end date provided 10-07-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary
Modification(s)  		 The ROSE Trial is a prospective, randomized, double blind, parallel group, investigator initiated study designed to evaluate the efficacy of Rosuvastatin, 20 milligrams daily, in patients with subclinical atherosclerosis. The study will be conducted at Apollo Rajshree Hospitals in Indore and will enroll 160 adults aged between thirty and seventy-five years with mild to moderate atherosclerotic changes. These changes are defined as carotid intima-media thickness of greater than 0.9 millimeters, coronary artery calcium score of less than 300, and luminal stenosis of less than 70 percent, but without a history of cardiovascular disease. Eligible participants will be randomized in a one-to-one ratio to receive Rosuvastatin or standard of care. The primary endpoints include changes in carotid intima-media thickness, plaque volume, peak systolic velocity, and luminal stenosis. Secondary endpoints include changes in lipid profile, high-sensitivity C-reactive protein, and coronary artery calcium scores. 
Close