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CTRI Number  CTRI/2023/06/053767 [Registered on: 12/06/2023] Trial Registered Prospectively
Last Modified On: 04/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic
Other (Specify) [optimizing the duration of anticoagulation]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Deciding the duration of blood thinners following acute venous thromboembolism (VTE) by assessing residual venous thrombosis by ultrasound scan 
Scientific Title of Study   Optimizing duration of anticoagulation following acute venous thromboembolism (VTE) by assessing residual venous thrombosis by ultrasound – a multicenter randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aneesh Basheer 
Designation  Prof of Internal Medicine 
Affiliation  Dr Moopens Medical College, Wayanad 
Address  Department of Internal Medicine Dr Moopens Medical College Naseera Nagar Meppadi

Wayanad
KERALA
673577
India 
Phone  9677154338  
Fax    
Email  basheeraneesh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aneesh Basheer 
Designation  Prof of Internal Medicine 
Affiliation  Dr Moopens Medical College, Wayanad 
Address  Department of Internal Medicine Dr Moopens Medical College Naseera Nagar Meppadi

Wayanad
KERALA
673577
India 
Phone  9677154338  
Fax    
Email  basheeraneesh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aneesh Basheer 
Designation  Prof of Internal Medicine 
Affiliation  Dr Moopens Medical College, Wayanad 
Address  Department of Internal Medicine Dr Moopens Medical College Naseera Nagar Meppadi

Wayanad
KERALA
673577
India 
Phone  9677154338  
Fax    
Email  basheeraneesh@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research,V Ramalingaswami Bhawan, Ansari Nagar, New Delhi  
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Indian Council Of Medical Research, V Ramalingaswami Bhawan, Ansari Nagar, Postbox 4911, New Delhi 110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aneesh Basheer  Dr Moopens Medical College  Department of General medicine, 1st Flor, Dr Moopens Medical College, Naseera Nagar, Meppadi,Wayanad 673577
Wayanad
KERALA 
9677154338

basheeraneesh@gmail.com 
Dr Nayyar Iqbal  Pondicherry Institute of Medical Sciences   Department of General Medicine, Pondicherry Institute of Medical Sciences, Ganapathichettikulam village No. 20, Kalapet, Puducherry 605014
Pondicherry
PONDICHERRY 
9629180164

drinayyar@gmail.com 
Dr Prabhakar K  Sri Devaraj Urs Medical College  Department of General Medicine, Sri Devaraj Urs Medical College, Tamaka, Kolar 563101
Kolar
KARNATAKA 
9448048308

drprabhakark@yahoo.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Central Ethics Committee URS  Approved 
Institutional Ethics Committee DM-WIMS  Approved 
Institutional Ethics Committee PIMS  Approved 
Institutional Ethics Committee SRI SATHYA SAI UNIVERSITY FOR HUMAN EXCELLENCE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I829||Embolism and thrombosis of unspecified vein,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fixed Anticoagulation  The fixed duration arm will receive additional 3 months of anticoagulation. 
Intervention  Flexible Anticoagulation  The flexible arm will be subjected to repeat ultrasound at 3, 9 and 15 months (if the DVT was unprovoked) or at 3 and 9 months (if the initial DVT was provoked). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adults >18 years diagnosed with acute lower limb DVT with or without associated pulmonary
embolism 
 
ExclusionCriteria 
Details  1.Previous VTE
2.Any indication for lifelong anticoagulation
3.Contraindications for anticoagulation
4.Active malignancy
5.Pregnancy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Recurrent VTE
2.Major bleeding  
1.30 months from randomization.
2.30 months from randomization. 
 
Secondary Outcome  
Outcome  TimePoints 
Sensitivity and specificity of PoCUS compared to formal venous scanning for detection of residual
venous thrombosis 
30 Months 
 
Target Sample Size   Total Sample Size="440"
Sample Size from India="440" 
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)   26/06/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  26/06/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Background: Presently treatment of VTE includes anticoagulation using injectable agents for a few days followed by 3 months of oral anticoagulation. Thereafter it is continued for 3 months in unprovoked VTE and no further in provoked DVT, based on observational data of recurrence rates during follow up. A randomized controlled trial using ultrasound scan for residual venous thrombosis found a lower recurrence of VTE compared to those given a fixed duration of anticoagulation. High quality data from experimental studies is therefore needed to confirm if this is generalizable and make evidence-based recommendations on duration of anticoagulation. 
Novelty: This is one of the first Indian studies addressing this research question and using a randomized controlled design (only one other study done so far). Data from multiple centers will increase external validity and use of point of care compression ultrasound (PoCUS) to ascertain residual venous thrombosis will enhance feasibility. 
Objectives: Primary objective is to determine efficacy of a flexible duration of extended anticoagulation based on repeat ultrasound for residual vein thrombosis compared to fixed duration of extended anticoagulation in reducing recurrent thrombotic events among patients with symptomatic deep vein thrombosis who have completed 3 months of anticoagulation. Secondary objective is to determine diagnostic accuracy of point of care compression ultrasound (PoCUS) compared to formal venous study for detection of residual venous thrombosis. 
Methods: This will be a randomized, parallel arm, multicenter study at 3 major hospitals treating venous thromboembolism. Consecutive patients diagnosed with first episode of VTE will be randomized to either a fixed duration anticoagulation or an ultrasound-guided duration based on detection of residual venous thrombosis. Both groups will be followed up for 30 months for primary objective of recurrent VTE. Secondary outcomes will be adverse events and duration of anticoagulation. 
Expected outcome: Results will enable making data driven, evidence-based changes to existing recommendation that is largely based on observational studies. Further it will establish diagnostic value of Point of care Ultrasound Scan (PoCUS) to rapidly detect residual venous occlusion among patients on anticoagulation for VTE.
 
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