| CTRI Number |
CTRI/2025/03/082798 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Duration of blood thinners for the prevention of Venous Thrombotic Events after venous stroke. |
|
Scientific Title of Study
|
Comparison of efficacy and saftey of short term versus long term oral anticoagulation for the prevention of Venous Thrombotic Events After an Episode of Acute Cerebral Venous thrombosis: An Open Label Randomized Controlled Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mritunjai Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Neurology, AIIMS Rishikesh
Department of Neurology AIIMS Rishikesh, Dehradun, UTTRANCHAL,249203,India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
09997010096 |
| Fax |
|
| Email |
mritunjaisingh68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shubhra Saraswat |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Neurology, Level 6, All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand- 249203, India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9045286779 |
| Fax |
|
| Email |
sourshubhra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mritunjai Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Neurology, AIIMS Rishikesh
Department of Neurology AIIMS Rishikesh, Dehradun, UTTRANCHAL,249203,India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
09997010096 |
| Fax |
|
| Email |
mritunjaisingh68@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neurology, Level 6, All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand- 249203, India
|
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
Department of Neurology AIIMS Rishikesh, Dehradun, UTTRANCHAL,249203,India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mritunjai Kumar |
AIIMS Rishikesh |
Department of Neurology, AIIMS Rishikesh
Dehradun
UTTARANCHAL |
09997010096
mritunjaisingh68@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I636||Cerebral infarction due to cerebral venous thrombosis, nonpyogenic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Long-Term Oral Anticoagulation Arm (6 Months) |
Long-Term Oral Anticoagulation Arm (6 Months): Participants in this arm will also receive initial anticoagulation therapy with either subcutaneous low molecular weight heparin (LMWH) or intravenous unfractionated heparin (UFH), with the choice determined by the treating physician based on clinical judgment. Once the patient’s acute condition is stable and they are deemed fit to start oral anticoagulation, but no later than one month after the diagnosis of CVT, they will be randomized into the long-term anticoagulation arm. Patients in this arm will transition from heparin therapy to oral anticoagulation with warfarin. The warfarin dose will be given once daily, orally and adjusted to maintain an International Normalized Ratio (INR) between 2.0 and 3.0. Warfarin therapy will continue for a total of six months from initiation, after which anticoagulation will be discontinued. Monitoring: INR monitoring will be performed regularly, initially on a weekly basis and then every two to four weeks once stable. |
| Comparator Agent |
Short-Term Oral Anticoagulation Arm (3 Months) |
Short-Term Oral Anticoagulation Arm (3 Months): Participants in this arm will initially receive anticoagulation therapy with either subcutaneous low molecular weight heparin (LMWH) or intravenous unfractionated heparin (UFH). The choice of initial anticoagulation will depend on the treating physician’s clinical judgment and patient-specific factors. Once the patient is deemed clinically stable and fit for oral anticoagulation, but no later than one month after the diagnosis of cerebral venous thrombosis (CVT), they will be randomized into the short-term anticoagulation arm. In this arm, participants will transition from heparin therapy to oral anticoagulation with warfarin. The warfarin dose will be given once daily, orally and adjusted to maintain an International Normalized Ratio (INR) between 2.0 and 3.0. Warfarin therapy will continue for a total duration of three months from initiation, after which anticoagulation will be discontinued. Monitoring: INR levels will be regularly monitored, with weekly checks at the start of therapy and then every two to four weeks once stable. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1. Patients with acute symptomatic and radiologically confirmed cerebral vein thrombosis (CVT).
2. CVT must have been diagnosed within 1 month before inclusion.
3. Written informed consent. |
|
| ExclusionCriteria |
| Details |
1. General contraindications for anticoagulant therapy.
2. Need for prolonged treatment with antiplatelet drugs, non-steroidal anti-inflammatory drugs or other drugs/diseases that interfere significantly with anticoagulant therapy or with INR assessment.
3. Life expectancy less than 2 years due to a pre-existing condition (including any malignancy).
4. Known allergy to study medications.
5. Other conditions judged by the investigator to be an absolute indication for prolonged oral anticoagulation such as recurrent CVT, venous thromboembolism (VTE) after CVT or first CVT with antiphospholipid syndrome or known severe thrombophilia (antithrombin, protein C or protein S deficiency, homozygous factor V Leiden or prothrombin G20210A mutation or combined abnormalities). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Primary efficacy outcome will be composite of Venous Thromboembolic Events (DVT, PE and recurrent CVT) at 12 months. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recanalization rate at 3 months and 6 months of anticoagulation therapy – as assessed by MRI Angiography. |
3 month and 6 month |
| Deep vein thrombosis (lower or upper limbs, pelvic or abdominal)- acute, symptomatic proximal deep-vein thrombosis of the legs, arms or of any abdominal vein, objectively verified with the use of compression ultrasonography or venography of leg veins or arm veins at 12 months. |
12 month |
| Pulmonary embolism: acute, symptomatic pulmonary embolism objectively verified with the use of ventilation-perfusion lung scanning, angiography or spiral computed tomography of pulmonary arteries at 12 months. |
12 month |
| Arterial thrombotic event (stroke, acute MI, acute arterial limb ischaemia, death proven to be secondary to an arterial vascular event) at 12 months. |
12 month |
Death proven to be secondary to a vascular event (arterial or venous), sudden
unexplained death (within 24 hour), nonvascular and death of unknown aetiology at 12 months |
12 month |
Functional outcome measured by Modified Rankin Scale (mRS-Score) at 3, 6 and 12
months. |
3 month, 6 month and 12 month |
| Safety Outcome minor and major Haemorrhage -rate of haemorrhagic stroke, symptomatic intracerebral haemorrhage or other symptomatic intracranial and extracranial haemorrhage like upper GI bleed etc |
3 month, 6 month, 12 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/03/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mritunjaisingh68@gmail.com].
- For how long will this data be available start date provided 24-02-2025 and end date provided 24-02-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Cerebral vein thrombosis (CVT) is a rare but serious condition that requires anticoagulation therapy to prevent thromboembolic recurrence. Current guidelines recommend oral anticoagulation for a duration of 3 to 12 months following acute CVT. However, these recommendations are largely extrapolated from studies on extracerebral venous thrombosis, such as deep vein thrombosis (DVT), which may not be entirely applicable to CVT. The risk of thrombotic recurrence after CVT appears to be lower compared to extracerebral venous thrombosis. Most recurrences occur within the first year, but the absolute risk remains relatively low both in isolation and in comparison to DVT. While extended anticoagulation could potentially reduce the risk of recurrence, it also increases the likelihood of major bleeding complications. Given the uncertainty regarding the optimal duration of anticoagulation in CVT, this study aims to determine the most appropriate duration of oral anticoagulation following acute, symptomatic, and radiologically confirmed CVT Null Hypothesis- Risk of venous thromboembolic event recurrence is similar in between 3 months and 6 months oral anticoagulation therapy. |