| CTRI Number |
CTRI/2025/02/080954 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
prevalence of low responders to statin therapy |
|
Scientific Title of Study
|
Proportion of low responders to statin therapy and its predictors: A tertiary care hospital based prospective interventional study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shamli Thakur |
| Designation |
Junior Resident |
| Affiliation |
INDIRA GANDHI MEDICAL COLLEGE SHIMLA (H.P) |
| Address |
Junior Resident, Department of Pharmacology IGMC Shimla
IGMC SHIMLA
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8894535927 |
| Fax |
|
| Email |
shamlithakur750@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anamika Thakur |
| Designation |
PROFESSOR |
| Affiliation |
INDIRA GANDHI MEDICAL COLLEGE SHIMLA (H.P) |
| Address |
Professor, Department of Pharmacology IGMC Shimla
IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8894535927 |
| Fax |
|
| Email |
dr.anamika.thakur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shamli thakur |
| Designation |
Junior resident |
| Affiliation |
Indira Gandhi Medical College Shimla(H.P) |
| Address |
Junior resident, department of Pharmacology IGMC Shimla
IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8894535927 |
| Fax |
|
| Email |
shamlithakur750@gmail.com |
|
|
Source of Monetary or Material Support
|
| IGMC SHIMLA, India
Pin code- 171001 |
|
|
Primary Sponsor
|
| Name |
SHAMLI THAKUR |
| Address |
IGMC Shimla, India
Pin code- 171001 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Shamli thakur |
Indira Gandhi Medical College Shimla(H.P) |
MRU lab, dental hospital building, 3rd floor
Shimla
HIMACHAL PRADESH |
8894535927
shamlithakur750@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDIRA GANDHI MEDICAL COLLEGE SHIMLA (H.P) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Tab Rosuvastatin 20 mg |
Tab Rosuvastatin 20 mg HS for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. patients with LDL more than or equal to 100 mg/dl with or without risk factors like smoking, obesity, hypertension, DM
2. Patients with LDL less than 100 mg/dl with risk factors |
|
| ExclusionCriteria |
| Details |
1. patients on other lipid lowering medications
2. patients not tolerating rosuvastatin
3. patients with active liver disease and myopathy
4. pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To estimate the Prevalence of low responders to Rosuvastatin in patients with atherosclerotic vascular disease and or at intermediate to high risk |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To study the clinical determinants of low responders to Rosuvastatin therapy |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/02/2025 |
| 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="0"
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 - NO
|
|
Brief Summary
|
This study is being conducted on patients with heart disease with high cholesterol levels and/or normal levels with high risk factors who have been prescribed Rosuvastatin 20 mg by treating cardiologist. As we know blockage of coronary arteries due to high cholesterol is the leading cause of death in India. This study will generate knowledge about variability in cholesterol lowering response of rosuvastatin in patients of heart disease. Suboptimal LDL cholesterol improvement is defined as less than 30 percent reduction in LDL levels and optimal LDL cholesterol improvement will be more than 30 percent reduction in LDL levels as compared to baseline levels. |