| CTRI Number |
CTRI/2022/01/039268 [Registered on: 10/01/2022] Trial Registered Prospectively |
| Last Modified On: |
07/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Long term survival and complications in patients operated for Prosthetic heart valves on Nicoumalone(Acenocoumarol) and tissue valve outcomes |
|
Scientific Title of Study
|
A Retrospective, Single Center, Observational Study to Evaluate Long-term survival of patients with valvular heart who underwent prosthetic valve replacement and were managed with Nicoumalone (Acenocoumarol) and tissue valve outcomes operated by a single surgeon |
| Trial Acronym |
ACNL-L21-0104 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ACNL-L21-0104, Version 02, Dated 11 Oct 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D S Saksena |
| Designation |
Cardiovascular and Thoracic Surgeon |
| Affiliation |
Bombay Hospital and Medical Research Centre, Mumbai |
| Address |
Room no. 130, Bombay Hospital and Medical Research Centre, Mumbai
12, New Marine Lines, Mumbai 400020.
Mumbai
MAHARASHTRA
400020
India |
| Phone |
|
| Fax |
|
| Email |
devsaksena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D S Saksena |
| Designation |
Cardiovascular and Thoracic Surgeon |
| Affiliation |
Bombay Hospital and Medical Research Centre, Mumbai |
| Address |
Room no. 130, Bombay Hospital and Medical Research Centre, Mumbai
12, New Marine Lines, Mumbai 400020.
Mumbai
MAHARASHTRA
400020
India |
| Phone |
|
| Fax |
|
| Email |
devsaksena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D S Saksena |
| Designation |
Cardiovascular and Thoracic Surgeon |
| Affiliation |
Bombay Hospital and Medical Research Centre, Mumbai |
| Address |
Room no. 130, Bombay Hospital and Medical Research Centre, Mumbai
12, New Marine Lines, Mumbai 400020.
Mumbai
MAHARASHTRA
400020
India |
| Phone |
|
| Fax |
|
| Email |
devsaksena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Abbott Healthcare Pvt Ltd, 3-4 Corporate Park Sion-Trombay Road Mumbai Maharashtra India 400071 |
|
|
Primary Sponsor
|
| Name |
Abbott Healthcare Pvt Ltd |
| Address |
Floor 16, Godrej BKC,
Plot No. C – 68, BKC,
Near MCA Club, Bandra (E)
Mumbai – 400 051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 D S Saksena |
Bombay Hospital and Medical Research Centre, Mumbai, |
12, Vitthaldas Thackersey Marg, Near to Liberty Cinema, New Marine Lines, Marine Lines, Mumbai, Maharashtra 400020
Mumbai
MAHARASHTRA |
9341757312
devsaksena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bombay Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I089||Rheumatic multiple valve disease,unspecified, (2) ICD-10 Condition: I348||Other nonrheumatic mitral valve disorders, (3) ICD-10 Condition: I719||Aortic aneurysm of unspecified site, without rupture, (4) ICD-10 Condition: Q874||Marfans syndrome, (5) ICD-10 Condition: I06||Rheumatic aortic valve diseases, (6) ICD-10 Condition: I05||Rheumatic mitral valve diseases, (7) ICD-10 Condition: I07||Rheumatic tricuspid valve diseases, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient who underwent prosthetic valve replacement since Jan 1971
2. Patient who were managed by Nicoumalone (Acenocoumarol) after the prosthetic valve replacement and whose dose titration was done based on the INR monitoring
3. Patient with no prior history of MACCE- Stroke, MI, and major bleeding
|
|
| ExclusionCriteria |
| Details |
1. Patient who underwent Cardiac Surgery other than Prosthetic Valve Replacement, eg. Coronary Artery Bypass Graft Surgery(CABG) etc.
2. Patient who underwent prosthetic valve replacement procedure before Jan 1971
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the overall survival of patients with VHD who underwent prosthetic valve replacement and managed with INR-based dose titration of Nicoumalone (Acenocoumarol) |
At the end of the follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the incidence of major complications associated with the disease like major adverse cardiac and cerebrovascular events (MACCE e.g., Stroke, MI) and major bleeding
2. To assess clinical outcome after surgery for Atrial Fibrillation with Mitral Valve pathology
3. To assess long time survival and clinical outcomes in patients who underwent aortic root enlargement with Aortic Valve surgery
4. To measure clinical outcome after Redo Cardiac surgery
5. To measure association between INR and Stroke or Valve Thrombosis
|
At the end of the follow-up |
|
|
Target Sample Size
|
Total Sample Size="718"
Sample Size from India="718"
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)
|
10/01/2022 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Currently in India, there is paucity of data on long-term survival of patients undergoing prosthetic valve replacement. Long-term data will provide the importance of addressing proper anticoagulation techniques to minimize postoperative thrombotic complications while maintaining acceptable levels of risk related to bleeding . The objective of this study proposed design is to assess the long term outcomes in patients with valvular heart disease who had undergone prosthetic valve replacement with adequate monitoring of the INR and dose titration of Acenocoumarol. |