Venous ThrombosisPhase 3NCT04967573
Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis
A Phase 3 study testing Rivaroxaban in people with Venous Thrombosis, run by Shanghai Zhongshan Hospital at 4 sites in China.
Trial summary
The efficacy and safety of anticoagulant treatment is not established for patients with acute symptomatic isolated distal deep vein thrombosis (IDDVT). The latest Antithrombotic Therapy for VTE Disease Guideline suggested using the same anticoagulation as for patients with acute proximal DVT in patients with acute… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- Rivaroxaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 4 sitesChina
- Study dates
- 1 Aug 2021to 31 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-90
- Outpatients with a first, acute (within 2 weeks), symptomatic, objectively confirmed isolated distal DVT
- Compliance to the scheduled follow up plan
- Ability and willing to participate and sign the informed consent.
Who cannot join
- Any absolute contraindication to anticoagulant treatment
- Pregnancy or breast-feeding
- Systolic pressure > 180 mmHg or diastolic pressure > 100 mmHg
- Platelet count < 100 × 10⁹ /L
- Serum creatinine > 180 mmol/L or creatinine clearance ≤30 ml/min
- Liver disease associated with coagulopathy and high risk of bleeding
Show all 11Show fewer
- Clinically suspected or confirmed pulmonary embolism
- Ipsilateral or contralateral proximal DVT
- Any indication for long-term anticoagulation
- Enrolled in another clinical trial simultaneously
- Life expectancy < 6 months
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Huadong Hospital affiliated to Fudan University
Shanghai
Wan Zhang, PhD
- Recruiting
Shanghai General Hospital
Shanghai
Jieqi Mao, PhD
- Recruiting
Shanghai Wusong Hospital
Shanghai
Yucheng Zhang, MD
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai
Zhenyu Shi, PhD
About this study
Official title: Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis (IDENT): a Prospective, Multicenter, Single-blind, Randomized Controlled Trial
The efficacy and safety of anticoagulant treatment is not established for patients with acute symptomatic isolated distal deep vein thrombosis (IDDVT). The latest Antithrombotic Therapy for VTE Disease Guideline suggested using the same anticoagulation as for patients with acute proximal DVT in patients with acute IDDVT. However, a single-center retrospective cohort study found therapeutic anticoagulation was associated with an increase risk of bleeding. Thus, this study aimed to assess the short-term risk of recurrent venous thrombotic events and bleeding events in patients with a first acute symptomatic IDDVT of the leg treated with prophylactic or therapeutic anticoagulant therapy with rivaroxaban.
- Conditions
- Venous Thrombosis
- Being tested
- Rivaroxaban
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Rivaroxaban 20 mg or 10 mg for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic Anticoagulation | Experimental | Rivaroxaban 10 mg od for 3 months Receives: Drug: Rivaroxaban |
| Therapeutic Anticoagulation | Active comparator | Rivaroxaban 20 mg od for 3 months Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographically confirmed recurrent venous thromboembolism
Recurrent venous thromboembolism includes proximal extension of isolated distal DVT, new contralateral proximal DVT and pulmonary embolism.
Measured: 6 months
Major or clinically relevant non-major bleeding events
Major bleeding events are defined according to the International Society on Thrombosis and Haemostasis criteria. Clinically relevant non-major bleeding events refer to which do not meet the mentioned criteria of major bleeding but need at least an unscheduled in-person consultant.
Measured: 3 months
Secondary outcomes (4)
Individual component of primary outcomes (e.g. proximal extension, major bleeding)
Individual component of primary outcomes, including proximal extension of isolated distal DVT, new contralateral proximal DVT, new pulmonary embolism, major bleeding events, clinically relevant non-major bleeding events.
Measured: 6 months
Residual vein occlusion
Measured: 6 months
Post-thrombotic syndrome
Measured: 6 months
All-cause death
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Aug 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenyu Shi, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967573
- Sponsor's protocol ID
- B2021-175R
- Status last verified
- Feb 2022
- First submitted
- 8 Jul 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou M, Zhang W, Zhang Y, Xie T, Mao J, Shi Z. Therapeutic or prophylactic anticoagulation in acute isolated distal deep vein thrombosis: protocol for a prospective, multicentre, single-blind, randomised controlled trial (TOP-IDDVT). BMJ Open. 2022 Feb 28;12(2):e056826. doi: 10.1136/bmjopen-2021-056826.
PubMed 35228291
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis (IDENT): a Prospective, Multicenter, Single-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04967573
- Acronym / sponsor ID
- B2021-175R
- Conditions
- Venous Thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The efficacy and safety of anticoagulant treatment is not established for patients with acute symptomatic isolated distal deep vein thrombosis (IDDVT). The latest Antithrombotic Therapy for VTE Disease Guideline suggested using the same anticoagulation as for patients with acute proximal DVT in patients with acute IDDVT. However, a single-center retrospective cohort study found therapeutic anticoagulation was associated with an increase risk of bleeding. Thus, this study aimed to assess the short-term risk of recurrent venous thrombotic events and bleeding events in patients with a first acute symptomatic IDDVT of the leg treated with prophylactic or therapeutic anticoagulant therapy with rivaroxaban.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic Anticoagulation | Experimental | Drug: RivaroxabanRivaroxaban 10 mg od for 3 months |
| Therapeutic Anticoagulation | Active comparator | Drug: RivaroxabanRivaroxaban 20 mg od for 3 months |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-90
- Outpatients with a first, acute (within 2 weeks), symptomatic, objectively confirmed isolated distal DVT
- Compliance to the scheduled follow up plan
- Ability and willing to participate and sign the informed consent.
Key exclusion criteria (11 listed)
- Any absolute contraindication to anticoagulant treatment
- Pregnancy or breast-feeding
- Systolic pressure > 180 mmHg or diastolic pressure > 100 mmHg
- Platelet count < 100 × 10⁹ /L
- Serum creatinine > 180 mmol/L or creatinine clearance ≤30 ml/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanRivaroxaban 20 mg or 10 mg for 3 months | Drug | Prophylactic Anticoagulation, Therapeutic Anticoagulation |
Primary outcome
Radiographically confirmed recurrent venous thromboembolism
Time frame: 6 months
Recurrent venous thromboembolism includes proximal extension of isolated distal DVT, new contralateral proximal DVT and pulmonary embolism.
Major or clinically relevant non-major bleeding events
Time frame: 3 months
Major bleeding events are defined according to the International Society on Thrombosis and Haemostasis criteria. Clinically relevant non-major bleeding events refer to which do not meet the mentioned criteria of major bleeding but need at least an unscheduled in-person consultant.
4 secondary outcomes
Individual component of primary outcomes (e.g. proximal extension, major bleeding)
Time frame: 6 months
Residual vein occlusion
Time frame: 6 months
Post-thrombotic syndrome
Time frame: 6 months
All-cause death
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Derived from this study: PubMed 35228291Zhou M, Zhang W, Zhang Y, Xie T, Mao J, Shi Z. Therapeutic or prophylactic anticoagulation in acute isolated distal deep vein thrombosis: protocol for a prospective, multicentre, single-blind, randomised controlled trial (TOP-IDDVT). BMJ Open. 2022 Feb 28;12(2):e056826. doi: 10.1136/bmjopen-2021-056826.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenyu Shi, PhD principal investigator
Fudan University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban in people with Venous Thrombosis, run by Shanghai Zhongshan Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiguo Fu, PhD (17612117633, fu.weiguo@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographically confirmed recurrent venous thromboembolism (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04967573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.