Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06118203
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2023-09-11
Brief Title:
Semaglutide Use in Acute Pulmonary Embolism
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Evaluation of Circulating Endothelial Inflammatory Biomarkers in Response to GLP-1 Agonist Semaglutide in Acute Pulmonary Embolism
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of circulating endothelial inflammatory biomarkers in response to GLP-1 agonist Semaglutide in acute pulmonary embolism
Detailed Description:
Study Rationale and riskbenefit analysis
This GLP-1 intervention study in patients with acute PE represents an original hypothesis in a population with unmet clinical need The results of this study could have important and immediate clinical implications in improving outcomes for this patient group The current long-term treatment of acute PE is limited to anticoagulation and there are no other studies investigating different treatment approaches Vascular inflammation is known to be an important factor driving thrombus evolution and vascular remodelling and therefore exploring the utility of targeting vascular inflammation is an important step forward in developing new treatment strategies for this common condition
We aim to conduct a proof-of-concept open label study with biomarker response to evaluate Semaglutide a GLP-1 agonist administered as add-on therapy to the standard of care in adult patients with acute PE treated in hospital Outcomes will be compared to a control group who will not receive the study drug The study will recruit adult patients with proximal or large clot burden PE with evidence of right ventricular dysfunction on admission This group has the highest risk of impaired clot resolution and of development of long-term complications including chronic thromboembolic disease
There is a low risk of study drug complications given the extensive availability of human clinical trial data with GLP-1 agonists There is also extensive real-world experience on the use of Semaglutide in the clinical investigation of glucose control in diabetes As the first dose of the study drug is administered in hospital clinical monitoring is optimised and common biochemical perturbations hypoglycaemia are easily interrogated and acted on by the clinical team Patients who have contraindications to the use of GLP-1 agonists and patients currently taking GLP-1 agonists for diabetes mellitus are excluded to reduce the risks associated with the study drug even further
Trial Objectives and Design
Trial Objectives
This proof-of-concept interventional study will comprise three separate but inter-linking aims
I Determine the effect of Semaglutide on highly glycosylated CD147- driven vascular inflammation in acute PE and GLP-1 receptor expression levels
II Evaluate immunological effects of Semaglutide in patients with acute PE T cell receptor expressioncytokine chemokine levels
III Determine the impact of Semaglutide on clot resolution and right ventricular recovery following acute PE
42 Primary endpoints Evaluate the change in highly glycosylated CD147 between day 0 and following 6 weeks of Semaglutide
43 Secondary endpoints I Determine the rate of persistent CTPA or VQ scan perfusion defects with Semaglutide
II Change in right ventricular function FAC andTASPE on echocardiography between day 0 and following 6 weeks of Semaglutide
III Change in plasma Cyclophylin A sCD147 D-dimer E selectin VCAM MMP levels NTproBNP GLP1-R Troponin myeloperoxidase activity
This GLP-1 intervention study in patients with acute PE represents an original hypothesis in a population with unmet clinical need The results of this study could have important and immediate clinical implications in improving outcomes for this patient group The current long-term treatment of acute PE is limited to anticoagulation and there are no other studies investigating different treatment approaches Vascular inflammation is known to be an important factor driving thrombus evolution and vascular remodelling and therefore exploring the utility of targeting vascular inflammation is an important step forward in developing new treatment strategies for this common condition
We aim to conduct a proof-of-concept open label study with biomarker response to evaluate Semaglutide a GLP-1 agonist administered as add-on therapy to the standard of care in adult patients with acute PE treated in hospital Outcomes will be compared to a control group who will not receive the study drug The study will recruit adult patients with proximal or large clot burden PE with evidence of right ventricular dysfunction on admission This group has the highest risk of impaired clot resolution and of development of long-term complications including chronic thromboembolic disease
There is a low risk of study drug complications given the extensive availability of human clinical trial data with GLP-1 agonists There is also extensive real-world experience on the use of Semaglutide in the clinical investigation of glucose control in diabetes As the first dose of the study drug is administered in hospital clinical monitoring is optimised and common biochemical perturbations hypoglycaemia are easily interrogated and acted on by the clinical team Patients who have contraindications to the use of GLP-1 agonists and patients currently taking GLP-1 agonists for diabetes mellitus are excluded to reduce the risks associated with the study drug even further
Trial Objectives and Design
Trial Objectives
This proof-of-concept interventional study will comprise three separate but inter-linking aims
I Determine the effect of Semaglutide on highly glycosylated CD147- driven vascular inflammation in acute PE and GLP-1 receptor expression levels
II Evaluate immunological effects of Semaglutide in patients with acute PE T cell receptor expressioncytokine chemokine levels
III Determine the impact of Semaglutide on clot resolution and right ventricular recovery following acute PE
42 Primary endpoints Evaluate the change in highly glycosylated CD147 between day 0 and following 6 weeks of Semaglutide
43 Secondary endpoints I Determine the rate of persistent CTPA or VQ scan perfusion defects with Semaglutide
II Change in right ventricular function FAC andTASPE on echocardiography between day 0 and following 6 weeks of Semaglutide
III Change in plasma Cyclophylin A sCD147 D-dimer E selectin VCAM MMP levels NTproBNP GLP1-R Troponin myeloperoxidase activity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None