An interventional study of Aspirin and rivaroxaban low dose in Healthy Volunteer, sponsored by Regeneron Pharmaceuticals. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-24.
Sponsored by Regeneron Pharmaceuticals · Not applicable, Interventional, and Screening
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.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.
Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
History of clinically significant respiratory, hepatic, renal, GI, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator that may confound the results of the study or poses an additional risk to the participant by study participation.
History of any atherosclerotic cardiovascular disease
NOTE: Other protocol defined inclusion / exclusion criteria apply.
Randomized 1:1:1
Drug: Aspirin
Randomized 1:1:1
Drug: Aspirin · Drug: rivaroxaban low dose
Randomized 1:1:1
Drug: Aspirin · Drug: rivaroxaban high dose
Administered orally once per day (QD)
Administered orally twice per day (BID)
Administered orally QD
Change from baseline in fecal hemoglobin content as measured by HemoQuant during the second week of exposure to study medication
HemoQuant is a chemical laboratory test of fecal hemoglobin content.
Time frame: Up to Week 4
Number of bleeding events during the baseline period as compared to the treatment period
Time frame: Up to week 4
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Regeneron Pharmaceuticals