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CTRI Number  CTRI/2023/10/059075 [Registered on: 25/10/2023] Trial Registered Prospectively
Last Modified On: 23/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Awareness and Adherence to Statin and Antiplatelet Therapy  
Scientific Title of Study   A Cross Sectional Observational Study to Evaluate Awareness of Patients to Drug Treatment and Adherence to Statin and Antiplatelet Therapy in Patients Suffering from Cardiovascular diseases 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Padmaja Marathe 
Designation  Profressor additional 
Affiliation  Seth G S medical college & kem hospital 
Address  Department of pharmacology & therapeutics, division of pharmacology first floor main college building, Admin block Seth gs medical college kem hospital mumbai-400011

Mumbai
MAHARASHTRA
400011
India 
Phone  9313811467  
Fax    
Email  pam2671@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Padmaja Marathe 
Designation  Profressor additional 
Affiliation  Seth G S medical college & kem hospital 
Address  Department of pharmacology & therapeutics, division of pharmacology first floor main college building, Admin block Seth gs medical college kem hospital mumbai-400011

Mumbai
MAHARASHTRA
400011
India 
Phone  9313811467  
Fax    
Email  pam2671@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Simran Khatri 
Designation  junior resident 
Affiliation  Seth G S medical college & kem hospital 
Address  Department of pharmacology & therapeutics, division of pharmacology first floor main college building, Demo room 2 Seth gs medical college kem hospital mumbai-400011

Mumbai
MAHARASHTRA
400012
India 
Phone  09426776376  
Fax    
Email  Simrankhatri844@gmail.com  
 
Source of Monetary or Material Support  
Department of pharmacology,Kem hospital & Seth gs medical, parel, mumbai, college 
 
Primary Sponsor  
Name  Seth GS Medical College KEM Hospital Diamond Jubilee Society Trust 
Address  first floor main medical college building, seth gs medical college & kem hospital, Acharya donde marg, parel mumbai 
Type of Sponsor  Government medical college 
 
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 PADMAJA MARATHE  SETH GS MEDICAL COLLEGE &KEM HOSPITAL  Department of pharmacology & therapeutics, division of pharmacology first floor main college building, Admin block SETH GS MEDICAL COLLEGE
Mumbai
MAHARASHTRA 
9619466099

pam2671@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee – II (Relating to Biomedical Health Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Male or female patients with age 18-75 years, who have been started on statins within a
period of previous 6 months to 5 years .
2. Patients who are planned for angioplasty or have undergone angioplasty in the past one
month of data collection who have routine blood investigation reports 
 
ExclusionCriteria 
Details  Newly diagnosed and treatment naive patients
2. Patients not willing to give informed consent.
3. Patients admitted in Cardiology IPD and emergency department.
4. Women with known pregnancy or desire to conceive within a year. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
awareness about statins in patient receiving statin
therapy 
12 months 
 
Secondary Outcome  
Outcome  TimePoints 
adherence to statin therapy and evaluate control of
hyperlipidaemia in patients on statin therapy 
12 months 
 
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   N/A 
Date of First Enrollment (India)   10/11/2023 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  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 [Simrankhatri844@gmail.com].

  6. For how long will this data be available start date provided 13-01-2025 and end date provided 13-01-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   India has one of the highest burdens of cardiovascular disease (CVD) worldwide. Statins are effective lipid-lowering drugs and prescribed widely for both primary prevention and secondary prevention of atherosclerotic cardiovascular diseases such as coronary heart diseases, stroke and peripheral artery diseases .Lack of knowledge plays an important role in adherence to therapy. Evidence suggests that inadequate knowledge about cholesterol or statin therapy is prevalent among statin users.Very few studies related to Drug Awareness and adherence to stain therapy has been done India.
Primary objective of the study is to study the awareness regarding statins in patients. Secondary objective is to evaluate adherence to statin and antiplatelet therapy in patients and to find out awareness about statins side effects in patients and to evaluate control of hyperlipidaemia in patients receiving statins.Study site will be Cardiology OPD at tertiary care hospital.
Patients on statin therapy will be screened according to the inclusion and exclusion criteria. Consent from those participants will be obtained who fulfil the eligibility criteria. Prior to consenting patient will be given a patient information sheet to know the details of the study. If the patient is unable to read, then it will be read out by the investigator or impartial witness, In simple language. Once the consent has been obtained, ICD will be signed, retained by the principal investigator and a copy of ICD will be given to patient. Each patient will be assigned a unique study identification number. After taking consent from patient, patients’ prescription will be scrutinized. Patients demographic details including age, sex, occupation, education and social economic status by Kuppuswamy classification will be noted. Duration of statin therapy of the patient will be documented. And changes in the medication will be recorded from previous prescription carried by the patient and comorbid conditions will also be noted. Details of the prescription current visit will be noted down which will include the drug name, dose, schedule, duration, route of administration. Patients’ lab investigation report will be scrutinized. Patients’ lipid profile and blood glucose profile will be noted down. Patient will be administered drug awareness and adherence questionnaire. Answers to the questions will be noted in a 15-20 min interview of the patient. Drug awareness questionnaire for patients will consist of total 15 questions. Drug awareness is defined as understanding about the medications provided by physician with respect to name of medication, indications, frequency, dosage, side effects. The questions have responses graded on a Likert scale with 2 options (Yes, No). Selected questions have sub questions and their responses will be recorded in descriptive form. Drug adherence questionnaire will consist of 2 sections one for adherence to statin therapy and one for adherence to antiplatelet therapy. Each section will have 6 questions. The questions have responses graded on a Likert scale with 2 options (Yes, No)
Primary Variable for the study will be  Drug awareness Score . Secondary Variables will be as follows:
1. Duration of statin treatment 2. Mean participant score 3. % Of participants who responded Yes or No to each item and sub-questions 4. Corelation analysis with patient and disease factors, drug awareness score.
Sample size of 300 patients will be considered. Patients attending Cardiology OPD, meeting the inclusion/ exclusion criteria during the study period will be enrolled.
For statistical analysis ,
Continuous variables would be presented as mean ± standard deviation (SD) .
Categorical data (e.g., Gender, education status, socioeconomic status) will be expressed as percentage.
Drug awareness questionnaire and Adherence questionnaire with variables of prescription pattern will be analysed using descriptive statistics .
Correlation analysis for Drug awareness score and Adverse Drug Reaction Capture table with scales.
 
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