| CTRI Number |
CTRI/2024/05/067704 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of concomitant use of Clopidogrel with Ilaprazole |
|
Scientific Title of Study
|
Pharmacodynamic evaluation of Clopidogrel coadministered with Ilaprazole - An Open-label Randomized Controlled Trial |
| 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 Priyadharshini A |
| Designation |
Assistant Professor |
| Affiliation |
SRM College of Pharmacy, SRM Institute of Science and Technology |
| Address |
Department of Pharmacy Practice, SRM Institute of Science and Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9787402050 |
| Fax |
|
| Email |
priyadha@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Damodharan N |
| Designation |
Professor |
| Affiliation |
SRM College of Pharmacy, SRM Institute of Science and Technology |
| Address |
Department of Pharmaceutics, SRM Institute of Science and Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9443591925 |
| Fax |
|
| Email |
damodhan@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Damodharan N |
| Designation |
Professor |
| Affiliation |
SRM College of Pharmacy, SRM Institute of Science and Technology |
| Address |
Department of Pharmaceutics, SRM Institute of Science and Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9443591925 |
| Fax |
|
| Email |
damodhan@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Kancheepuram Tamilnadu 603203 |
|
|
Primary Sponsor
|
| Name |
SRM College of Pharmacy, SRM Institute of Science and Technology |
| Address |
SRM Nagar Kattankulathur Kancheepuram Tamilnadu 603203 |
| 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 Priyadharshini A |
SRM Medical College Hospital & Research Center |
Department of Cardiology Fourth Floor B Block
Kancheepuram
TAMIL NADU |
9787402050
priyadha@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I248||Other forms of acute ischemic heart disease, (2) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1 |
Clopidogrel (75 mg) + Pantoprazole (40 mg) in 30 patients for duration of 21 days |
| Intervention |
Group 2 |
Clopidogrel (75 mg) + Ilaprazole (10 mg) in 30 patients for duration of 21 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with Acute coronary syndrome and willing to give informed consent form |
|
| ExclusionCriteria |
| Details |
Concomitant drugs that affects CYP2C19 metabolism
Pregnancy/ Lactating women
Patient with liver disease
Patient with pscyhiatric disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Monitoring of Platelet Reactivity Index |
From Baseline,7th,14th and 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Monitoring complete blood count parameters of the study enrolled participants
2. Monitoring of any adverse events during the study |
From Baseline,7th,14th and 21st day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/07/2024 |
| 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="0"
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
|
Clopidogrel inhibits platelet aggregation and is indicated for preventing vascular ischemia associated with atherothrombotic events. The human cytochrome P450 (P450) isoforms are involved in the two oxidative steps in the bioactivation of clopidogrel (prodrug) to its pharmacologically active metabolite. Common clinical practice involved the coadministration of a proton pump inhibitor with clopidogrel to reduce the risk of upper gastrointestinal bleeding associated with clopidogrel use. All PPIs are also metabolized via the cytochrome P450 system, particularly CYP2C19, and CYP3A4.
PPIs inhibit these isoenzymes to different degrees and therefore could affect the clinical efficacy of clopidogrel. Many studies reported an unexpected decrease in clopidogrel efficacy when co-administered with PPIs, Metabolism of clopidogrel requires cytochrome P450s (CYPs), including CYP2C19. However, PPIs may inhibit CYP2C19, potentially reducing the effectiveness of clopidogrel. Currently, researches are focused on more potent PPIs.
Some studies have shown that ilaprazole might be a new substitute. The irreversible inactivation of CYP2C19 is the mechanism by which omeprazole and esomeprazole reduce the efficacy of clopidogrel. This property is not shared by lansoprazole, pantoprazole, rabeprazole or ilaprazole. Based on data from many pharmacokinetic and pharmacodynamic studies, pantoprazole is the least likely to interact, and ilaprazole, lansoprazole, and rabeprazole may be a suitable alternative. There is insufficient evidence regarding which PPI among pantoprazole, ilaprazole is least likely to interact and there have been no studies to date to specifically compare the effect of ilaprazole on clinical outcomes in patients taking clopidogrel. |