| CTRI Number |
CTRI/2024/09/074343 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a study comparing the effect of two drugs namely sacubitril-valsartan and telmisartan in patients who get acute myocardial infarction or heart attack by seeing the effect of drugs on change in structure and functioning of heart muscles also known as remodelling seen using echocardiography as outcome |
|
Scientific Title of Study
|
Sacubitril Valsartan versus Telmisartan in remodeling of left ventricleafter acute anterior wall 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 |
Amitoj singh sagoo |
| Designation |
Resident cardiology |
| Affiliation |
Government medical college and hospital |
| Address |
cardiology department B block Level 5, Government medical college and hospital, sector 32, Chandigarh
Fatehgarh Sahib
PUNJAB
160030
India |
| Phone |
9888979319 |
| Fax |
|
| Email |
dramitojsingh7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amitoj singh sagoo |
| Designation |
Resident cardiology student |
| Affiliation |
Government medical college and hospital |
| Address |
cardiology department B block Level 5, Government medical college and hospital, sector 32, Chandigarh
Fatehgarh Sahib
PUNJAB
160030
India |
| Phone |
9888979319 |
| Fax |
|
| Email |
dramitojsingh7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amitoj singh sagoo |
| Designation |
Resident cardiology |
| Affiliation |
Government medical college and hospital |
| Address |
cardiology department B block Level 5, Government medical college and hospital, sector 32, Chandigarh
Fatehgarh Sahib
PUNJAB
160030
India |
| Phone |
9888979319 |
| Fax |
|
| Email |
dramitojsingh7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and hospital, sector 32 , chandigarh pin code 160030, India |
|
|
Primary Sponsor
|
| Name |
Government medical college and hospital |
| Address |
Government medical college and hospital, sector 32 chandigarh, 160030 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Amitoj singh |
Government medical college and hospital |
cardiology department D block Level 5
Fatehgarh Sahib
PUNJAB |
9888979319
dramitojsingh7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (GMCH, Chandigarh) |
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: I220||Subsequent ST elevation (STEMI) myocardial infarction of anterior wall, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
drug name sacubitril valsartan |
patients of anterior wall myocardial infarctin with heart failure will be divided into two groups. group A will be given sacubitril valsartan dose 50 mg twice daily and group B will be given telmisartan 40 mg once daily |
| Comparator Agent |
drug name telmisartan |
patients of anterior wall myocardial infarctin with heart failure will be divided into two groups. group A will be given sacubitril valsartan dose 50 mg twice daily and group B will be given telmisartan 40 mg once daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 to 70 years.
2. Patients with Acute Anterior Wall Myocardial Infarction within past 7 days. undergoing coronary angiography.
3. Adequate echocardiographic image quality.
4. Availability of a follow-up evaluation at 6 and 12 months.
|
|
| ExclusionCriteria |
| Details |
1. Previous heart failure.
2. Renal dysfunction with eGFR of less than 60 ml per minute per 1.73 m2.
3. History of angioedema.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To monitor LV remodelling (i.e. increase in LVEDV by more than 20% occuring anytime over a period of one year) among the patients with AMI receiving sacubitril valsartan or telmisartan. |
To monitor LV remodelling (i.e. increase in LVEDV by more than 20% occuring anytime over a period of one year) among the patients with AMI receiving sacubitril valsartan or telmisartan.
time points are 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in levels of cardiac biomarkers(Troponin I and BNP) among the patients with AMI receiving sacubitril valsartan or telmisartan at baseline, 6 months and after one year. |
To compare the changes in levels of cardiac biomarkers(Troponin I and BNP) among the patients with AMI receiving sacubitril valsartan or telmisartan at baseline, 6 months and after one year.
time points are 6 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/10/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
: The study will be conducted in the Department of Cardiology at Government Medical College and Hospital (GMCH), Chandigarh. Patients of Acute Anterior wall Myocardial Infarction attending the cardiology Outpatient department or being admitted from emergency will be enrolled. Randomization will be done within 7 days of acute MI into two groups. Group A patients will start on sacubitril valsartan. Group B patients will be managed with Telmisartan-based therapy . Patients will be followed up at 6 and 12 months with repeated investigations including cardiac biomarkers and Echocardiography to monitor LV Remodeling in both repeated groups. |