| CTRI Number |
CTRI/2025/04/084937 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Behavioral |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Studying the Safety and Effectiveness of Single vs. Combined Blood Thinner Treatments in Heart Disease Patients |
|
Scientific Title of Study
|
Comparative Assessment of Safety and Efficacy of Mono and Dual Anti-platelet therapy in Coronary Artery Disease patients: A Prospective Cohort Study in a Tertiary care Hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mandati Santhosh Reddy |
| Designation |
Assistant Professor |
| Affiliation |
KLE College of Pharmacy, Belagavi |
| Address |
Floor-03 Room:14,
Department of Pharmacy Practice,
KLE College of Pharmacy, Belagavi
Floor-03 Room:14,
Department of Pharmacy Practice,
KLE College of Pharmacy, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9494601698 |
| Fax |
|
| Email |
mandatisanthoshreddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mandati Santhosh Reddy |
| Designation |
Assistant Professor |
| Affiliation |
KLE College of Pharmacy, Belagavi |
| Address |
Floor-03 Room:14,
Department of Pharmacy Practice,
KLE College of Pharmacy, Belagavi
Floor-03 Room:14,
Department of Pharmacy Practice,
KLE College of Pharmacy, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9494601698 |
| Fax |
|
| Email |
mandatisanthoshreddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mandati Santhosh Reddy |
| Designation |
Assistant Professor |
| Affiliation |
KLE College of Pharmacy, Belagavi |
| Address |
Floor-03 Room:14,
Department of Pharmacy Practice,
KLE College of Pharmacy, Belagavi
Floor-03 Room:14,
Department of Pharmacy Practice,
KLE College of Pharmacy, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9494601698 |
| Fax |
|
| Email |
mandatisanthoshreddy@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KLE College of Pharmacy Belagavi |
| Address |
KLE College of Pharmacy Belagavi, JNMC campus, Nehru Nagar 590010 Karnataka, India |
| 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 |
| DrMSGanachari |
KLES Dr Prabhakar Kore Hospital and MRC |
G+2, Department of General Medicine, Nehru Nagar Belagavi-590010, Karnataka, India
Belgaum
KARNATAKA |
9448634457
msganachari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I519||Heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Arm 2 (Comparator agent)
Mono antiplatelet therapy |
Drug Name: Aspirin
Dose: Aspirin 75 mg once daily
Route of Administration: Oral
Frequency: Once daily
Total Duration of Intervention: 24 months |
| Intervention |
Arm 1 (Intervention Group)
Dual Antiplatelet therapy |
Drug Name: Aspirin + Clopidogrel
Dose: Aspirin 75 mg once daily + Clopidogrel 75 mg once daily
Route of Administration: Oral
Frequency: Once daily
Total Duration of Intervention: 24 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients Diagnosed with CAD receiving antiplatelet therapy (IPD & OPD)
Patients aged 18 years and older of both sexes.
Patients who provide informed consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patients with known contraindications to antiplatelet therapy, such as active bleeding disorders.
Patients with severe co morbid conditions that could confound study outcomes (Advanced liver disease, several renal impairment, malignancies).
• Patients who have undergone major surgery within the last 3 months.
Pregnant or breastfeeding women.
Patients with terminal illness whose life expectancy is less than 1 year
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy – Clinical Outcomes, Patient reported outcomes
Safety – Bleeding events, Adverse Drug reactions, All cause mortality
|
Baseline, 03 Months, 06 Months, and 12 Months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
QoL – WHO BREF
Cost analysis – Direct & Indirect costs |
Baseline, 03 Months, 06 Months, & 12 Months
|
|
|
Target Sample Size
|
Total Sample Size="440"
Sample Size from India="440"
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)
|
01/05/2025 |
| 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="3"
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
|
Risk
of bleeding and other ADRs associated with antiplatelet therapy are well
documented, but most data comes from clinical trials with strict inclusion
criteria. There is insufficient evidence on Incidence, severity
and causality of Adverse Drug Reactions in a Heterogeneous population over a
prolonged period, especially in a tertiary care setting. Investigating
therapy transitions have not been thoroughly explored in past studies.
There
is lack of comprehensive data on Medication Related Problems in
patients receiving Mono and Dual antiplatelet therapies, particularly regarding
how these problems evolve and impact the long term therapy outcomes.
Patients
on antiplatelet therapy are at risk of medication related problems, which can
lead to suboptimal therapeutic outcomes, increased morbidity and higher health
care costs. Systematic identification and analysis of these problems can help in
optimizing therapy and improving patient care.
|