Trial · NCT05825573
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Net clinical benefit of DOA in comparison to VKA in patients with intra-cardiac thrombus | 6 months | Composite endpoint of all-cause death, myocardial infarction, stroke, acute peripheral emboli, acute pulmonary embolism, thrombus persistence and clinically relevant bleedings (BARC 2 to 5 bleedings) |
| Secondary | All cause death between groups | 6 months | Any death documented during the follow-up independently of cause of death |
| Secondary | All cause death between groups | 12 months | Any death documented during the follow-up independently of cause of death |
| Secondary | Myocardial infarction occurrence between groups | 6 months | All non-fatal MI, excluding MI type 3, which will be captured separately as death |
| Secondary | Myocardial infarction occurrence between groups | 12 months | All non-fatal MI, excluding MI type 3, which will be captured separately as death |
| Secondary | Stroke occurrence between groups | 6 months | Classified as Transient ischemic attack (TIA), Ischemic Stroke, Haemorrhagic Stroke and Undetermined Stroke |
| Secondary | Stroke occurrence between groups | 12 months | Classified as Transient ischemic attack (TIA), Ischemic Stroke, Haemorrhagic Stroke and Undetermined Stroke |
| Secondary | Acute peripheral emboli occurrence between groups | 6 months | All acute artery occlusion (limb, renal or digestive artery occlusion confirmed by clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing |
| Secondary | Acute peripheral emboli occurrence between groups | 12 months | All acute artery occlusion (limb, renal or digestive artery occlusion confirmed by clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing |
| Secondary | Acute pulmonary embolism occurrence between groups | 6 months | Defined as partial or complete occlusion of pulmonary artery or one of its branch confirmed by consistent clinical history and supported by evidence of embolism from surgical specimens, autopsy, angiography or vascular imaging in accordance to international guidelines |
| Secondary | Acute pulmonary embolism occurrence between groups | 12 months | Defined as partial or complete occlusion of pulmonary artery or one of its branch confirmed by consistent clinical history and supported by evidence of embolism from surgical specimens, autopsy, angiography or vascular imaging in accordance to international guidelines |
| Secondary | Thrombus persistence between groups | 6 months | Defined by cardiac imaging (echocardiography, contrast echocardiography, cardiac CT scan or cardiac MRI) as an increased thrombus dimension, a stable thrombus, or a partial thrombus regression |
| Secondary | Thrombus persistence between groups | 12 months | Defined by cardiac imaging (echocardiography, contrast echocardiography, cardiac CT scan or cardiac MRI) as an increased thrombus dimension, a stable thrombus, or a partial thrombus regression |
| Secondary | Clinically relevant bleedings between groups | 6 months | International Bleeding Academic Research Consortium (BARC) types 2 to 5 |
| Secondary | Clinically relevant bleedings between groups | 12 months | International Bleeding Academic Research Consortium (BARC) types 2 to 5 |
| Secondary | Systemic embolism between groups | 6 months | defined by the composite of stroke, embolic myocardial infarction, peripheral artery occlusion and acute pulmonary embolism |
| Secondary | Systemic embolism between groups | 12 months | defined by the composite of stroke, embolic myocardial infarction, peripheral artery occlusion and acute pulmonary embolism |
| Secondary | Cardiovascular death between groups | 6 months | Any death due to myocardial infarction, ischemic and haemorrhagic stroke, systemic embolism, sudden death, low-output failure, fatal arrhythmia, cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other cardiovascular cause. All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided. |
| Secondary | Cardiovascular death between groups | 12 months | Any death due to myocardial infarction, ischemic and haemorrhagic stroke, systemic embolism, sudden death, low-output failure, fatal arrhythmia, cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other cardiovascular cause. All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided. |
| Secondary | Total thrombus recurrence between groups | 6 months | Recurrence of thrombus on cardiac imaging control following a total thrombus regression during the follow-up |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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