Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-02-19 @ 1:53 AM
Study NCT ID:
NCT05546957
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2022-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban in Healthy Adult Participants
Sponsor:
Regeneron Pharmaceuticals
Organization:
Study Overview
Official Title:
A Parallel Group Study in Healthy Participants to Quantify Subclinical Gastrointestinal Blood Loss Following Administration of Aspirin Alone or Aspirin in Combination With Rivaroxaban
Status:
COMPLETED
Status Verified Date:
2023-05
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:
The primary objective of the study is to determine whether aspirin alone or aspirin combined with various doses of rivaroxaban causes subclinical GI blood loss as determined by the HemoQuant assay.
The secondary objective of the study is to evaluate the safety and tolerability of aspirin alone or in combination with rivaroxaban to healthy volunteers.
The secondary objective of the study is to evaluate the safety and tolerability of aspirin alone or in combination with rivaroxaban to healthy volunteers.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-002761-15 | EUDRACT_NUMBER | None | View |