| CTRI Number |
CTRI/2025/12/098510 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Other (Specify) [Patient Education ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Clinical Pharmacist Services in Medication Taking and Recovery of Heart Attack Patients after Stent Procedure |
|
Scientific Title of Study
|
Impact of Clinical Pharmacy Services on Medication Adherence and Clinical Outcomes in Post-Percutaneous Coronary Intervention Patients with ST-Elevation Myocardial Infarction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sajan Francis P |
| Designation |
Research Scholar |
| Affiliation |
Yenepoya Pharmacy College and Research Center |
| Address |
Department of Pharmacy Practice,
Yenepoya Pharmacy College and Research Center,
Ayush campus, Naringana, Deralakatte,
Mangalore - 575018 Karnataka State, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9496653086 |
| Fax |
|
| Email |
sajanfrancisp1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Treesa P Varghese |
| Designation |
Associate Professor and Head of the Department |
| Affiliation |
Yenepoya Pharmacy College and Research Center |
| Address |
Department of Pharmacy Practice,
Yenepoya Pharmacy College and Research Center,
Ayush campus, Naringana, Deralakatte,
Mangalore - 575018 Karnataka State, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9496656112 |
| Fax |
|
| Email |
treesap@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sajan Francis P |
| Designation |
Research Scholar |
| Affiliation |
Yenepoya Pharmacy College and Research Center |
| Address |
Department of Pharmacy Practice,
Yenepoya Pharmacy College and Research Center,
Ayush campus, Naringana, Deralakatte,
Mangalore - 575018 Karnataka State, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9496653086 |
| Fax |
|
| Email |
sajanfrancisp1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vivekanandha Medical Care Hospital,Elayampalayam,Tiruchengode,Namakkal district,Tamil Nadu-637205,India |
|
|
Primary Sponsor
|
| Name |
Sajan Francis P |
| Address |
Department of Pharmacy Practice,
Yenepoya Pharmacy College and Research Center,
Ayush campus, Naringana, Deralakatte,
Mangalore - 575018 Karnataka State, India |
| Type of Sponsor |
Other [Self Funded ] |
|
|
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 K Jayaprakash |
Vivekanandha Medical Care Hospital |
Elayampalayam,Tiruchengode
Namakkal
TAMIL NADU |
9843662291
pharmacypractice2007@svcop.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Vivekanandha Medical Care Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I220||Subsequent ST elevation (STEMI) myocardial infarction of anterior wall, (2) ICD-10 Condition: I221||Subsequent ST elevation (STEMI) myocardial infarction of inferior wall, (3) ICD-10 Condition: I228||Subsequent ST elevation (STEMI) myocardial infarction of other sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clinical Pharmacist Led Patient Education Plus Usual Cardiac Care |
Hospitalized STEMI patients undergoing PCI will receive structured clinical pharmacist led education in addition to usual cardiac care. The clinical pharmacist will provide individualized counseling on indication, dose, timing, and duration of all post PCI medicines. The pharmacist will reinforce adherence, review prescriptions daily for drug related problems, and provide a written information leaflet. Patients will receive discharge counseling and follow up reinforcement through telephone and outpatient department visits at predefined intervals to improve medication adherence and clinical outcomes.Clinical Pharmacy Services such as patient education will be given for the patients for the period of 1 Year |
| Comparator Agent |
Usual Standard Cardiac Care |
Hospitalized STEMI patients undergoing PCI will receive usual standard cardiac care provided by cardiologists and ward staff as per hospital protocol. No structured clinical pharmacist led education or additional adherence focused intervention will be given beyond routine practice. Medication adherence and clinical outcomes of both groups will be compared at follow up. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 years to 65 Years.
Patients diagnosed with ST-Elevation Myocardial Infarction (STEMI) and admitted to the hospital for its management.
Patients undergoing their first-ever Percutaneous Coronary Intervention (PCI) procedure as part of their STEMI treatment.
Patients willing to participate in the study and provide informed consent.
Patients or their caregivers who have access to a smartphone.
|
|
| ExclusionCriteria |
| Details |
Patients with chronic conditions such as carcinoma or other severe chronic illnesses that may impact study participation.
Patients who do not have access to a smartphone.
Patients unwilling to participate in the study.
Patients with cognitive impairment or any condition that prevents effective communication and participation.
Patients with a history of prior PCI or coronary artery bypass grafting (CABG).
If any patient developed restenosis soon after the PCI the sample will be sent to lab for testing P2Y12 to confirm the resistance towards the anti-platelet drugs, if any resistance patients will be removed from the study.
Patient those who are not willing for biomarker assessment during follow-up.
Patients who fail to attend any scheduled follow-up assessments, leading to incomplete data collection during the study period will be excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in medication adherence and clinical outcome rates among STEMI patients post-primary PCI, assessed by validated adherence measurement tools at specified follow-up intervals |
0,3,6,9,12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/12/2025 |
| 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 - NO
|
|
Brief Summary
|
This prospective interventional study aims to evaluate the impact of clinical pharmacy services on medication adherence and clinical outcomes in patients with ST-elevation myocardial infarction (STEMI) who have undergone primary percutaneous coronary intervention (PCI). Conducted at Vivekanandha Medical Care Hospital, the study will enroll 100 eligible STEMI patients randomized to intervention and control groups. The intervention group will receive structured clinical pharmacist-led services, including medication counseling, adherence monitoring using validated scales, patient education via telephonic communication, and management of drug-related problems. Primary outcomes include medication adherence improvement measured by the Morisky Medication Adherence Scale and reduction of major adverse cardiovascular events, with follow-ups at 3, 6, 9, and 12 months. Secondary outcomes assess quality of life and determinants of in-stent restenosis. The study addresses a critical gap in Indian cardiac care by integrating pharmacist interventions to improve patient outcomes and reduce complications post-PCI. Ethical approval has been obtained, and the study duration is December 2025 to July 2027. |