Odense University Hospital — Biomedical Watch V2

Traitements12programmes

Essais4liés

Publications3liées

SourceDBlocale

Traitements

12

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
BioFreedomThe aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) IX STEMI OCT is to compare early vascular healing of the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI).	Maladie coronarienne	Non applicable	À vérifier	Denmark	À vérifier
Continuation of daily low-dose AspirinDAN-RELEASE is a national, randomized, registry-based trial including 7,000 participants in Denmark. The trial aims to determine whether discontinuation of long-term aspirin therapy is non-inferior to continued aspirin therapy in older adults with stable ischemic heart disease. Long-term aspirin therapy is recommended for patients with established ischemic heart disease. However, among clinically stable patients years after percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or myocardial infarction (MI), the evidence supporting lifelong aspirin therapy is limited. At the same time, the risk of serious bleeding increases with age. DAN-RELEASE will therefore compare aspirin discontinuation with continued aspirin therapy in adults aged 65 years or older with stable ischemic heart disease who have remained free from ischemic events for at least two years. The trial will assess whether discontinuing aspirin is non-inferior to continued treatment with respect to cardiovascular and bleeding outcomes.	Maladie coronarienne	Phase 4	À vérifier	Denmark	À vérifier
Conventional duration of aspirin and prasugrelThe SORT OUT XII dual antiplatelet treatment (DAPT) duration trial, is a clinical randomized controlled superiority and non-inferiority trial to compare whether prasugrel alone versus prasugrel plus aspirin from month 1 to month 12 after percutaneous coronary intervention with and everolimus-eluting stent in patients with acute coronary syndromes (1) is superior regarding clinically relevant bleeding and (2) non-inferior regarding safety (cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization)	Maladie coronarienne	Phase 4	À vérifier	Denmark	À vérifier
Discontinuation of daily low-dose AspirinDAN-RELEASE is a national, randomized, registry-based trial including 7,000 participants in Denmark. The trial aims to determine whether discontinuation of long-term aspirin therapy is non-inferior to continued aspirin therapy in older adults with stable ischemic heart disease. Long-term aspirin therapy is recommended for patients with established ischemic heart disease. However, among clinically stable patients years after percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or myocardial infarction (MI), the evidence supporting lifelong aspirin therapy is limited. At the same time, the risk of serious bleeding increases with age. DAN-RELEASE will therefore compare aspirin discontinuation with continued aspirin therapy in adults aged 65 years or older with stable ischemic heart disease who have remained free from ischemic events for at least two years. The trial will assess whether discontinuing aspirin is non-inferior to continued treatment with respect to cardiovascular and bleeding outcomes.	Maladie coronarienne	Phase 4	À vérifier	Denmark	À vérifier
OrsiroThe aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) IX STEMI OCT is to compare early vascular healing of the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI).	Maladie coronarienne	Non applicable	À vérifier	Denmark	À vérifier
Short duration of aspirin and prasugrelThe SORT OUT XII dual antiplatelet treatment (DAPT) duration trial, is a clinical randomized controlled superiority and non-inferiority trial to compare whether prasugrel alone versus prasugrel plus aspirin from month 1 to month 12 after percutaneous coronary intervention with and everolimus-eluting stent in patients with acute coronary syndromes (1) is superior regarding clinically relevant bleeding and (2) non-inferior regarding safety (cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization)	Maladie coronarienne	Phase 4	À vérifier	Denmark	À vérifier
Turning OFF the neuromodulatorA multi-center double-blinded placebo-controlled randomized clinical trial. The patients will be randomized into two groups. To investigate the efficacy of SNM to improve the key bladder diary variables compared to placebo (i.e. sham) for patients with MS having refractory neurogenic lower urinary tract dysfunction (NLUTD). After first step SNM-procedure and a 3-4 weeks test period patients with more than 50% improvement in the key bladder diary variables will have the IPG implanted. After a month of optimization patients will into two groups: IPG ON or IPG OFF. Period of randomization: four months. Number anticipated to be included: 60 patients	SEP	Non applicable	Traitement symptomatique	Denmark	À vérifier
Turning ON the neuromodulatorA multi-center double-blinded placebo-controlled randomized clinical trial. The patients will be randomized into two groups. To investigate the efficacy of SNM to improve the key bladder diary variables compared to placebo (i.e. sham) for patients with MS having refractory neurogenic lower urinary tract dysfunction (NLUTD). After first step SNM-procedure and a 3-4 weeks test period patients with more than 50% improvement in the key bladder diary variables will have the IPG implanted. After a month of optimization patients will into two groups: IPG ON or IPG OFF. Period of randomization: four months. Number anticipated to be included: 60 patients	SEP	Non applicable	Traitement symptomatique	Denmark	À vérifier
Turning ON the neuromodulatorA multi-center double-blinded placebo-controlled randomized clinical trial. The patients will be randomized into two groups. To investigate the efficacy of SNM to improve the key bladder diary variables compared to placebo (i.e. sham) for patients with MS having refractory neurogenic lower urinary tract dysfunction (NLUTD). After first step SNM-procedure and a 3-4 weeks test period patients with more than 50% improvement in the key bladder diary variables will have the IPG implanted. After a month of optimization patients will into two groups: IPG ON or IPG OFF. Period of randomization: four months. Number anticipated to be included: 60 patients	SEP	Non applicable	Traitement symptomatique	Denmark	À vérifier
Continuation of daily low-dose AspirinDAN-RELEASE is a national, randomized, registry-based trial including 7,000 participants in Denmark. The trial aims to determine whether discontinuation of long-term aspirin therapy is non-inferior to continued aspirin therapy in older adults with stable ischemic heart disease. Long-term aspirin therapy is recommended for patients with established ischemic heart disease. However, among clinically stable patients years after percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or myocardial infarction (MI), the evidence supporting lifelong aspirin therapy is limited. At the same time, the risk of serious bleeding increases with age. DAN-RELEASE will therefore compare aspirin discontinuation with continued aspirin therapy in adults aged 65 years or older with stable ischemic heart disease who have remained free from ischemic events for at least two years. The trial will assess whether discontinuing aspirin is non-inferior to continued treatment with respect to cardiovascular and bleeding outcomes.	Maladie coronarienne	Phase 4	À vérifier	Denmark	À vérifier
Short duration of aspirin and prasugrelThe SORT OUT XII dual antiplatelet treatment (DAPT) duration trial, is a clinical randomized controlled superiority and non-inferiority trial to compare whether prasugrel alone versus prasugrel plus aspirin from month 1 to month 12 after percutaneous coronary intervention with and everolimus-eluting stent in patients with acute coronary syndromes (1) is superior regarding clinically relevant bleeding and (2) non-inferior regarding safety (cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization)	Maladie coronarienne	Phase 4	À vérifier	Denmark	À vérifier
BioFreedomThe aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) IX STEMI OCT is to compare early vascular healing of the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI).	Maladie coronarienne	Non applicable	À vérifier	Denmark	À vérifier

Essais cliniques

4

Molécule	Indication / population	Phase	NCT	Titre	Statut
BioFreedom	Maladie coronarienne	Non applicable	NCT02915107	OCT STEMI SOIX — The SORT OUT IX STEMI OCT Trial	COMPLETED
Short duration of aspirin and prasugrel	Maladie coronarienne	Phase 4	NCT06718179	SORT OUT DAPT — Comparison of Short Versus 12 Months Prasugrel Plus Aspirin in Patients With Acute Coronary Syndromes Treated With Percutaneous Coronary Intervention and Everolimus-eluting Stents	TERMINATED
Continuation of daily low-dose Aspirin	Maladie coronarienne	Phase 4	NCT07795398	DAN-RELEASE - Reconsidering Long-Term Aspirin in the Elderly Patients With Stable Ischemic Heart Disease	RECRUITING
Turning ON the neuromodulator	SEP	Non applicable	NCT05380856	Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction	RECRUITING

Publications

3

Molécule	Indication / population	Titre	Journal	Date
Turning OFF the neuromodulator		Management of a Hypoglossal Nerve, Upper Airway Stimulator in the Pain Patient: Safety Considerations.	Pain practice : the official journal of World Institute of Pain
Turning OFF the neuromodulator		Patients' Perspectives and Challenges with Sacral Neuromodulation Implantable Pulse Generator.	International urogynecology journal
Turning OFF the neuromodulator		A neuroprosthesis for restoring hand movement and sensation in a person with complete tetraplegia.	Nature medicine