Best Antithrombotic Therapy in Patients With Acute Venous ThromboEmbolism While Taking Antiplatelets (BAT-VTE)
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| ClinicalTrials.gov Identifier: NCT05627375 |
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Recruitment Status :
Recruiting
First Posted : November 25, 2022
Last Update Posted : March 6, 2024
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Venous thromboembolism (VTE) and atherosclerotic cardiovascular disease share common risk factors and frequently coexist in the same patients.
Their management requires use of antithrombotic agents: anticoagulant therapy (AC) for secondary prevention of VTE recurrence, antiplatelet (AP) for secondary prevention of major adverse ischemic cardiovascular and cerebrovascular event (MACCE) in patients with atherosclerotic cardiovascular disease (coronary artery disease, atherosclerotic cerebrovascular disease, lower extremity peripheral arterial disease).
Side effects of antithrombotic drugs are the 1st cause of emergency admission and hospitalization for an adverse drug reaction (mainly bleeding), and the combination of AC with AP strongly increases this risk.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Venous Thromboembolic Disease | Drug: Full-dose anticoagulant therapy (AC) Drug: Antiplatelet therapy (AP) | Phase 3 |
Up to one third of VTE patients receive concomitant AP therapy, with conflicting results on patient outcomes. Concomitant therapy (AC+AP) has been associated with a higher risk of bleeding (up to 3-fold) when aspirin was associated with vitamin-K antagonist (VKA) in a multicenter cohort study, or with direct oral anticoagulants (DOACs) for acute VTE in a post-hoc subgroup analysis. Conversely, patients with acute VTE in whom clinicians decided to maintain AC+AP were found to have an increased risk of MACCE without any higher risk of bleeding, in a multicenter registry. However, in most cases, the type (aspirin or another) and indication (primary versus secondary prevention) of AP was unknown, as was the duration of the combination AC+AP, and therefore these observational results may be confounded. Therefore, there is persistent equipoise regarding the benefit/risk of combining an antiplatelet therapy with anticoagulation in patients undergoing treatment for VTE, when there is a prior history of atherosclerotic cardiovascular disease. This may explain why clinical practice varies widely.
Considering the conflicting data about the risk of bleeding in patients on AP therapy for secondary prevention, who need to start full-dose anticoagulant therapy for acute VTE, a randomized trial comparing the two strategies, in patients with acute VTE and with history of stable atherosclerotic cardiovascular disease is needed and justified.
The investigators hypothesize that a strategy based on the prescription of a full-dose AC therapy alone will decrease the risk of bleeding, when compared to the the strategy of combined AP and full-dose AC therapies, and that this strategy will translate in a positive net clinical benefit (a composite of clinically relevant bleeding, recurrent venous thromboembolism, and major adverse ischemic cardiovascular and cerebrovascular events).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1400 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Best Antithrombotic Therapy in Patients With Acute Venous ThromboEmbolism While Taking Antiplatelets |
| Actual Study Start Date : | August 16, 2023 |
| Estimated Primary Completion Date : | December 2027 |
| Estimated Study Completion Date : | December 2028 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: strategy of full-dose anticoagulant therapy alone (AC)
The experimental group receiving full-dose anticoagulant therapy alone (AC). Anticoagulant (AC) therapy :at the investigator's discretion in accordance with international recommendations for the management of DVT/PE Antiplatelet therapy will be stopped. |
Drug: Full-dose anticoagulant therapy (AC)
Anticoagulant (AC) therapy: at the investigator's discretion in accordance with international recommendations for the management of DVT/PE |
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Active Comparator: strategy of combined full-dose anticoagulant and antiplatelet therapies (AC+AP)
The control group receiving the standard of care: Antiplatelet therapy will be combined to full-dose anticoagulant therapy. Anticoagulant (AC) therapy :at the investigator's discretion in accordance with international recommendations for the management of DVT/PE Antiplatelet (AP) therapy : Aspirin or Clopidogrel |
Drug: Full-dose anticoagulant therapy (AC)
Anticoagulant (AC) therapy: at the investigator's discretion in accordance with international recommendations for the management of DVT/PE Drug: Antiplatelet therapy (AP) Aspirin (at a daily dose ≤100 mg) or Clopidogrel (at a daily dose ≤75mg) |
- Clinically relevant bleeding [ Time Frame: end of the full-dose treatment period, up to 12 months ]Clinically relevant bleeding is composite of major bleeding events and clinically relevant non-major bleeding events).
- Net clinical benefit [ Time Frame: end of the full-dose AC treatment period, up to 12 months ]Net clinical benefit is defined by the composite of clinically relevant bleeding, recurrent venous thromboembolism, and major adverse ischemic cardiovascular and cerebrovascular events
- Clinically relevant non-major bleeding [ Time Frame: end of the full-dose treatment period, up to 12 months ]
- Major bleeding events [ Time Frame: end of the full-dose treatment period, up to 12 months ]
- recurrent venous thromboembolism [ Time Frame: end of the full-dose treatment period, up to 12 months ]proximal deep venous thromboembolism and/or pulmonary embolism symptomatic or incidental, and including fatal-PE
- arterial events [ Time Frame: end of the full-dose treatment period, up to 12 months ]major adverse cardiovascular and cerebrovascular events (nonfatal ischemic stroke, nonfatal myocardial infarction, acute lower limb ischemia, lower limb amputation or revascularization for vascular causes, cardiovascular deaths),
- venous thromboembolism (VTE) sequels [ Time Frame: end of the full-dose treatment period, up to 12 months ]post-thrombotic syndrome (defined as a Villalta score up to 4) and post-PE syndrome (defined as the combination of a persistant dyspnea with a NYHA (New York Heart Association) scale more than I with residual vascular obstruction on lung scan
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion criteria
- Signed informed consent
- Patients with acute objectively confirmed symptomatic proximal deep-vein thrombosis (DVT) or pulmonary embolism (PE) (with or without deep-vein thrombosis). Proximal deep-vein thrombosis is defined as thrombosis involving at least the popliteal vein or a more proximal vein of the lower limb.
- Indication of full-dose anticoagulant therapy for at least 3 months.
- Prescription of antiplatelet therapy for secondary prevention of atherosclerotic cardiovascular diseases, at the time of VTE diagnosis
- Life expectancy more than 3 months
- Social security affiliation
Exclusion Criteria:
- Unable to give informed consent
- Active bleeding or a high risk of bleeding contraindicating anticoagulant treatment; a systolic blood pressure of more than 180 mm Hg or a diastolic blood pressure of more than 110 mm Hg
- Anticoagulation for more than 5 days prior to randomization
- Active pregnancy or expected pregnancy or no effective contraception
- Isolated distal deep vein thrombosis
- Antiplatelet therapy prescribed for primary prevention of cardiovascular disease
- Indication to maintain a dual-antiplatelet therapy.
- Triple positive antiphospholipid syndrome, with arterial thrombosis
- Major cardiovascular and cerebrovascular event in the past 12 months for acute coronary syndrome, and in the past 6 months for cerebrovascular diseases and peripheral arterial diseases
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05627375
| Contact: Laurent BERTOLETTI, MD PhD | (0)477829121 ext +33 | laurent.bertoletti@chu-st-etienne.fr | |
| Contact: Carine LABRUYERE | (0)477120469 ext +33 | carine.labruyere@chu-st-etienne.fr |
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| Principal Investigator: | Laurent BERTOLETTI, MD PhD | CHU Saint-Etienne |
| Responsible Party: | Centre Hospitalier Universitaire de Saint Etienne |
| ClinicalTrials.gov Identifier: | NCT05627375 |
| Other Study ID Numbers: |
20PH285 |
| First Posted: | November 25, 2022 Key Record Dates |
| Last Update Posted: | March 6, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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deep venous thrombosis pulmonary embolism anticoagulant antiplatelet |
Venous Thromboembolism Direct oral anticoagulants major adverse ischemic cardiovascular and cerebrovascular event secondary prevention |
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Thromboembolism Venous Thromboembolism Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Anticoagulants |