| CTRI Number |
CTRI/2024/02/062185 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prescription audit for Drug awareness and Adherence in Post heart attack Patients |
|
Scientific Title of Study
|
Evaluation of Prescription Pattern of Drugs and Drug awareness and Adherence to treatment in Post Myocardial Infarction Patients |
| Trial Acronym |
PDAA IN MI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yashashri Shetty |
| Designation |
Associate Professor |
| Affiliation |
Seth GS Medical College and KEM Hospital, Mumbai |
| Address |
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224107444 |
| Fax |
|
| Email |
yashashrirajit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yashashri Shetty |
| Designation |
Associate Professor |
| Affiliation |
Seth GS Medical College and KEM Hospital, Mumbai |
| Address |
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224107444 |
| Fax |
|
| Email |
yashashrirajit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yashashri Shetty |
| Designation |
Associate Professor |
| Affiliation |
Seth GS Medical College and KEM Hospital, Mumbai |
| Address |
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224107444 |
| Fax |
|
| Email |
yashashrirajit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth G S Medical College and KEM Hospital, Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Yashashri Shetty |
| Address |
Seth GS Medical College and KEM Hospital, Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Madhuri Doke |
Department of Cardiology |
Cardiology OPD, room no 10 and 13, Ground floor, CVTC building Seth GS Medical College and KEM Hospital, Mumbai
Mumbai
MAHARASHTRA |
7499991622
madhuridoke09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients carrying treatment records prescribed at Cardiology OPD of KEM hospital or outside KEM hospital containing post myocardial infarction medication regimen for at least 3 months.
|
|
| ExclusionCriteria |
| Details |
Patients or Legally Authorized Representative(LAR) not willing to give written informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WHO prescribing indicators |
At baseline and at 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of patients aware of the Secondary prevention treatment given for post myocardial infarction patients
ï‚· The awareness can be correlated with demographic factors (Age, gender, occupation, education, and socio-economic status) and co-morbidities.
ï‚· Percentage of Patient adhering to treatment, and this also can be correlated with demographic factor (Age, gender, occupation, education, and socio-economic status)
|
Baseline to 6 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)
|
06/02/2024 |
| 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="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
|
AIMS & OBJECTIVES: Prescription pattern studies gives us insight about the trends of drugs commonly used in primary /secondary prevention of myocardial infarction. Limited prescription audit studies in India on drugs used for secondary prevention of MI, made us do this study aiming to evaluate the prescription pattern of drugs in post myocardial infarction patients along with their adherence, awareness, and probable clinical outcomes. METHODOLOGY: After approval from ethics committee (EC), a prospective, cross-sectional, observational, single-centered, questionnaire-based study was conducted in 300 post MI patients. The prescription patterns, adherence and awareness were analyzed using descriptive statistics. |