Table of contents
- Clinical trials overview
- Acute venous thromboembolism and antiplatelet therapy
- After transcatheter aortic valve implantation
- Balloon pulmonary angioplasty in chronic thromboembolic disease
- Mechanical heart valves and low INR
- Colonoscopy and polypectomy studies
- Intra-cardiac thrombus trial
- Main endpoints across the trials
Clinical trials overview
The trial data show several Phase 3 studies of Acenocoumarol in different clot-related settings.[1] These studies are interventional, which means researchers assign treatments and compare outcomes between groups.[1] Most trials are authorised and include adults with conditions where blood clot prevention or treatment is important.[1]
Across the trials, Acenocoumarol is studied alongside other anticoagulants and, in some studies, antiplatelet medicines.[1] The main question is not how the drug works in the body, but which treatment strategy gives the best balance between preventing clots and avoiding bleeding.[1]
Acute venous thromboembolism and antiplatelet therapy
The BAT-VTE trial studies patients with an acute venous thromboembolism event who are already taking antiplatelet treatment for secondary arterial prevention at the time of diagnosis.[2] This trial is Phase 3 and plans to enrol 1,400 people.[2]
The main goal is to compare full-dose anticoagulant therapy alone with a combination of antiplatelet and full-dose anticoagulant therapy.[2] The primary outcome is clinically relevant bleeding, which includes major bleeding and clinically relevant non-major bleeding, measured by the end of the full-dose treatment period or up to 12 months.[2]
Acenocoumarol appears in the intervention list as one of the oral anticoagulant options used in this study.[2] The patient group is important because they already need antiplatelet therapy, so the trial is testing whether anticoagulant treatment alone may reduce bleeding risk.[2]
After transcatheter aortic valve implantation
The POPular ATLANTIS trial studies people with aortic valve stenosis after transcatheter aortic valve implantation, also called TAVI, and specifically includes patients without an existing indication for oral anticoagulation.[3] This is a Phase 3, international, multicentre, randomized clinical trial with 2,600 planned participants.[3]
The study compares a personalized, CT-guided antithrombotic strategy with lifelong single antiplatelet therapy.[3] CT-guided means the treatment plan is based on information from a CT scan, which is an imaging test that gives detailed pictures of the body.[3]
The primary endpoints are thromboembolic events and all bleeding events.[3] Thromboembolic events include cardiovascular death, ischaemic stroke, transient ischaemic attack, myocardial infarction, systemic embolism, and clinically significant valve thrombosis.[3] Acenocoumarol is one of the anticoagulant options listed in the trial interventions.[3]
Balloon pulmonary angioplasty in chronic thromboembolic disease
The 2024-518803-23-00 trial studies anticoagulant medicines for balloon pulmonary angioplasty, or BPA, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Chronic Thromboembolic Disease (CTED) without Pulmonary Hypertension.[4] It is a Phase 3 study with 84 planned participants.[4]
This trial compares direct oral anticoagulants with vitamin K antagonists.[4] Acenocoumarol is listed as one of the vitamin K antagonist options in the study.[4]
The main endpoint is a combined measure of periprocedural bleeding or lung injury within 24 hours after BPA, assessed on a per-session basis.[4] Periprocedural means around the time of the procedure, and lung injury in this study includes radiographic opacity, with or without coughing up blood or low oxygen levels.[4]
Mechanical heart valves and low INR
The LIMIT trial studies patients receiving a vitamin K antagonist because they have a mechanical bileaflet aortic valve replacement.[5] It is a Phase 3 trial with 2,625 planned participants.[5]
The study evaluates whether a common, lower INR range can reduce bleeding while still protecting against clotting problems.[5] INR stands for international normalized ratio, a blood test used to measure how strongly blood is thinned.[5]
The primary outcome combines thrombosis or thromboembolism, including ischaemic stroke, systemic thromboembolism, and valve thrombosis, together with major bleeding.[5] Acenocoumarol is one of the vitamin K antagonists included in the intervention list.[5]
Colonoscopy and polypectomy studies
Two trials study patients who need colonoscopy and are already taking anticoagulants or antiplatelets.[6][7] These studies are important because polypectomy, which means removal of a polyp, can cause bleeding.[6][7]
The POLYPHEM trial includes patients receiving oral anticoagulant therapy who are scheduled for elective colonoscopy for any reason.[6] It is a Phase 3 non-inferiority trial with 394 planned participants.[6] The main outcome is haemorrhage after polypectomy.[6] Acenocoumarol is one of the anticoagulants being studied in this setting.[6]
The second colonoscopy study, 2024-511265-11-01, includes patients who are requested to have a colonoscopy and are taking antiplatelet treatment, except ASA, or anticoagulant treatment.[7] It is also Phase 3 and plans to enrol 686 people.[7] The main outcome is significant post-polypectomy hemorrhage after removal of small non-pedunculated polyps with a cold snare, which is a wire loop used to cut the polyp without heat.[7]
In this study, the question is whether continuing anticoagulants or antiplatelets leads to a bleeding risk that is not higher than in the control group, where treatment is withdrawn according to current practice.[7] Acenocoumarol is one of the anticoagulants included in the intervention list.[7]
Intra-cardiac thrombus trial
The ARGONAUT trial studies patients with intra-cardiac thrombus, which means a blood clot inside the heart.[8] It is a Phase 3 interventional study with 340 planned participants.[8]
The study compares direct oral anticoagulants with vitamin K antagonists, which are the reference treatment in this trial.[8] Acenocoumarol is included among the vitamin K antagonist options.[8]
The main outcome is a net clinical benefit endpoint at 6 months.[8] This endpoint combines death from any cause, myocardial infarction, stroke, acute peripheral emboli, acute pulmonary embolism, thrombus persistence, and clinically relevant bleeding.[8]
Main endpoints across the trials
Across these studies, the most common endpoints are bleeding outcomes and clot-related outcomes.[2][3][4][5][6][7][8] Bleeding outcomes include clinically relevant bleeding, major bleeding, haemorrhage after polypectomy, and significant post-polypectomy hemorrhage.[2][5][6][7]
Clot-related outcomes include thromboembolic events, valve thrombosis, thrombosis or thromboembolism, thrombus persistence, stroke, myocardial infarction, systemic embolism, and pulmonary embolism.[3][5][8] Some trials also include procedure-related safety outcomes such as vascular injury, access site problems, or lung injury after BPA.[4]
Overall, the trial data show that Acenocoumarol is being studied in several different clinical situations where doctors must balance clot prevention against bleeding risk.[1] The studies are focused on real patient groups rather than healthy volunteers, and they aim to guide treatment choices in complex situations.[1]
