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| ID | Type | Description | Link |
|---|---|---|---|
| G-002409 | Other Grant/Funding Number | Barts Charity |
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The LVT DURATION (Optimal Duration of Anticoagulation for LV Thrombus) is a pilot study planned to assess the practicalities of conducting a randomised control trial (RCT) whilst establishing data around the ideal duration of anticoagulation in the treatment of LV thrombus. The main objectives of the study are:
After randomisation participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continue pre prescribed rivaroxaban or apixaban or warfarin | Experimental | If randomised to this arm, participants will continue on their rivaroxaban or apixaban or warfarin for the study related time period. |
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| Discontinue pre prescribed rivaroxaban or apixaban or warfarin | Experimental | If randomised to this arm, patients (who have already been on OAC for a period of 3 months) will discontinue their rivaroxaban or apixaban or warfarin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continue rivaroxaban or apixaban or warfarin | Drug | The study is asessing the impact of discontinuation of oral anticoagulation in patients with LV thrombus diagnosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stroke and Systemic Embolism (SSE) | Number of SSE events following randomisation | 6 months |
| All-Cause Mortality | Number of deaths from any cause following randomisation | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major Bleeding | Rates of major bleeding (BARC ≥ 3) events following randomisation. | 6 months |
| Minor Bleeding | Rates of minor bleeding (BARC ≤ 2) events following randomisation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Dan Jones | Contact | 02037658707 | dan.jones8@nhs.net | |
| Mervyn Andiapen | Contact | 02037658707 | mervyn.andiapen@nhs.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Bartholomews Hospital | London | EC1A4BE | United Kingdom |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C522181 | apixaban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Discontinue rivaroxaban or apixaban or warfarin | Drug | discontinue rivaroxaban or apixaban or warfarin |
|
| 6 months. |
| New LV Thrombi | Rates of new LV thrombus formation between the groups. | 6 months |
| Resolved Thrombus | Rates of LV thrombus resolution between the groups. | 6 months |
| Hospitalisation | Total number of days in hospital between continuing versus stopping anticoagulation. | 6 months |
| Cost Comparison | Total measured costs between continuing versus stopping anticoagulation. | 6 months |
| MI | Number of participants experiencing MI following randomisation | 6 months |
| EQ-5D-5L | Quality of life of participants measured by EQ-5D-5L. | 6 months |
| Perspectives of Clinicians and Patients | Qualitative assessment of clinician and patient views on study design, procedures, and relevance, collected via structured interviews and surveys | 6 months |
| Target Vessel Revascularization (TVR) | Number of participants undergoing TVR following randomisation | 6 months |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |