| CTRI Number |
CTRI/2023/03/050170 [Registered on: 01/03/2023] Trial Registered Prospectively |
| Last Modified On: |
17/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of effect of proton pump inhibitor in management of atherosclerotic
cardiovascular disease |
|
Scientific Title of Study
|
OUTCOME OF PROTON PUMP INHIBITOR CO-ADMINISTRATION WITH DUAL
ANTIPLATELET THERAPY IN THE MANAGEMENT OF ATHEROSCLEROTIC
CARDIOVASCULAR DISEASE: A RETROSPECTIVE REAL-WORLD STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gauri Debashish Dhanaki |
| Designation |
Trial Coordinator |
| Affiliation |
Dr Reddys Laboratories ltd |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad 500016 Telangana India
Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad 500016 Telangana India
Hyderabad
TELANGANA
500016
India |
| Phone |
|
| Fax |
|
| Email |
gauridebashish@drreddys.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashank Desai |
| Designation |
Medical Advisor |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad 500016 Telangana India
Hyderabad
TELANGANA
500016
India |
| Phone |
|
| Fax |
|
| Email |
shashankdesai@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Rathod |
| Designation |
Medical Cluster Head Ideation and CR Medical Affairs |
| Affiliation |
Dr Reddys Laboratories ltd |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-2 Ameerpet Hyderabad 500016 Telangana India
Hyderabad
TELANGANA
500016
India |
| Phone |
|
| Fax |
|
| Email |
rahul.rathod@drreddys.com |
|
|
Source of Monetary or Material Support
|
| Dr Reddys Laboratories Limited
Global Generics India
7-1-27 Ameerpet
Hyderabad 500016
Telangana India |
|
|
Primary Sponsor
|
| Name |
Dr Reddys Laboratories Ltd |
| Address |
Dr Reddys Laboratories Limited
Global Generics India 7-1-27 Ameerpet Hyderabad 500016
Telangana India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rishi Vinod Lohiya |
Healthy Heart Clinic |
Gala No. 3, Beside Cafe Coffee Day Ashapura Society Near Daneson Lawn Wardhaman Nagar Square Central Avenue Road Nagpur 08 Maharashtra
Nagpur
MAHARASHTRA |
9320182115
rishidr123@rediffmail.com |
| Dr Anand Subramaniyan |
Kauvery Heart City |
Room Number 1, Department of Cardiology, Alexandriya Road Cantonment Tiruchirapalli Tamilnadu 620001
Tiruchirappalli
TAMIL NADU |
7708867791
anandsubbu81@yahoo.co.in |
| Dr Hitanshu R Panchal |
Savita Superspeciality Hospital |
Room no. 101, Cardiology department, Parivar Char Rasta Waghodia Dabhoi Ring Road, Vadodara 390019
Vadodara
GUJARAT |
9662090655
panchalhitanshu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethic Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I700||Atherosclerosis of aorta, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with documented history of atherosclerotic cardiovascular disease using dual antiplatelet drugs along with PPIs |
|
| ExclusionCriteria |
| Details |
Patients with a history of peptic ulcer or gastric or duodenal surgery
Patients with erosive esophagitis and gastric-outlet obstruction
Patients treated with multiple anti-ulcer medications
Patients with severe pulmonary, hepatic, or renal disease
Patients with incomplete records
Patients on anticoagulants other than aspirin plus clopidogrel and on PPIs other than rabeprazole, pantoprazole and esomeprazole. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome of co administration of various currently used
PPIs with dual antiplatelet therapy in
patients of atherosclerotic cardiovascular
disease will be analyzed in terms of percentage of Myocardial infarction Stroke Unstable angina Heart failure Rehospitalization for
cardiovascular related illness
Repeat percutaneous coronary
intervention or coronary artery bypass grafting
Death Bleeding events Stent thrombosis |
Baseline to end of 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The outcome of
co administration of rabeprazole vs other
PPIs (pantoprazole, esomeprazole) with
dual antiplatelet therapy in patients of atherosclerotic cardiovascular
disease will be analyzed in terms of percentage of Myocardial infarction Stroke Unstable angina Heart failure Rehospitalization for
cardiovascular related illness
Repeat percutaneous coronary
intervention or coronary artery bypass grafting
Death Bleeding events Stent thrombosis |
Baseline to end of 12 months |
|
|
Target Sample Size
|
Total Sample Size="511"
Sample Size from India="511"
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)
|
06/03/2023 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an EMR based retrospective, observational, longitudinal, multicenter real-world study
designed to analyze the data from inpatient and outpatient settings up to 10-15 healthcare centers
across various regions of India. The anonymized medical records with follow up visits data of 12
months at baseline, follow-up visit 1 (3 ± 1 month), follow-up visit 2 (6 ± 1 month), follow-up
visit 3 (9 ± 1 month) and after 12 months (12 ± 1 month) will be taken into consideration. The
anonymized data of ASCVD patients on co-administration of various currently used PPIs with
dual antiplatelet therapy will be considered for the analysis and all concomitants medication will
be reported as available in database / medical records |