| 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
|
|
|
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
|
|
|
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. |