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CTRI Number  CTRI/2020/08/027406 [Registered on: 26/08/2020] Trial Registered Prospectively
Last Modified On: 15/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Open label randomized control trial "Comparision of valsartan plus sacubitril vs ramipril in acute myocardial infarction with HFmEF and HFrEF" 
Scientific Title of Study   "Sacubitril plus Valsartan Vs Ramipril in acute myocardial infarction with heart failure with reduced and mid range ejection fraction :A Randomized control trial" 
Trial Acronym  CARAMI 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rama Chandra Barik 
Designation  Associate Professor  
Affiliation  AIIMS BBSR 
Address  Cardiology department aiims bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9491634156  
Fax    
Email  ramachandra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rama Chandra Barik 
Designation  Associate Professor  
Affiliation  AIIMS BBSR 
Address  Cardiology department aiims bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9491634156  
Fax    
Email  ramachandra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rama Chandra Barik 
Designation  Associate Professor  
Affiliation  AIIMS BBSR 
Address  Cardiology department aiims bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9491634156  
Fax    
Email  ramachandra@gmail.com  
 
Source of Monetary or Material Support  
AIIMS BHUBANESWAR ODISHA 
 
Primary Sponsor  
Name  aiims hospital  
Address  bhubaneswar 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
JOGENDRA SINGH  AIIMS BHUBANESWAR  Department of cardiology
Khordha
ORISSA 		 8076662061

joy.vmmcmbbs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMSBBSR   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Angiotensin receptor neprolysin inhibitor  angiotensin receptor blocker blocks the angiotensin receptor which help in reducing negative remodeling and neprolysin inhibitor inhibit the endopeptidase which degrade the natriuretic peptides so by blocking this natriuretic peptides not degrade and shows positive effect  
Intervention  ARNI(ANGIOTENSION RECEPTOR AND NEPROLYSIN INHIBITOR)  50mg to 200mg Twice a day Orally 3 months 
Comparator Agent  RAMIPRIL(ANGIOTENSIN CONVERTING ENZYME INHIBITOR)  1.25mg to 5mg Twice a day Orally 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Diagnosis of spontaneous AMI based on the universal MI definition (2018) -with randomization to occur between 12 hours and 7 days after index MI presentation.
2.EF would calculate using ECHO after index MI presentation and prior to randomization
3.Systolic blood pressure at enrolment would be minimum ≥100mmHg irrespective of ongoing beta blocker or ACEI
 
 
ExclusionCriteria 
Details  1. Cardiogenic shock
2. Coronary artery bypass graft (CABG)
3. Right ventricular MI
4. A known history of angioedema
5. Stroke /transient ischemic attack
6. Bilateral renal artery stenosis
7. Obstructive cardiomyopathy
8. Serum creatinine >2.2 mg/dl
9. Total bilirubin > 3.0 mg/dL)
10. Cirrhosis
11. Previous use of ARNI
12. History of malignancy  
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in LVEF% (increase in LVEF by 10% from baseline) measured by Simpson’s rule  15 months 
 
Secondary Outcome  
Outcome  TimePoints 

Monitoring change in NYHA functional class
Monitoring NT pro BNP level in blood
Monitoring serum creatinine and potassium level in blood
 		 15 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 
Date of First Enrollment (India)   26/08/2020 
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="2"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   ARNI is a novel combination which has been recently introduced in heart failure reduced ejection fraction (HFrEF) and mid-range ejection fraction (HFmEF) treatment regimen and provides symptomatic relief, improve New York Heart Association (NYHA) functional class, reduces rate of readmission for heart failure and also reduces mortality significantly. However, the number of original researches related to ARNI vs ACEI/ARB are scarce and most of them are in pipeline. This study in our institute would enlighten about the change in ejection fraction, NYHA class, NT pro -BNP level, serum k+, creatinine level when used in patients just after myocardial infarction with heart failure with reduced ejection fraction (HFrEF) and HFmEF and follow up for a period of 3 months.  
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