Study to quantify subclinical GI blood loss following administration of Aspirin and Rivaroxaban
Research type
Research Study
Full 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
IRAS ID
1006402
Contact name
Muriel O'Byrne
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2022-002761-15
Clinicaltrials.gov Identifier
Research summary
This study is a randomised, open-label, parallel group trial in normal healthy volunteers. Aspirin and rivaroxaban will be administered at approved doses as study medications. The primary objective of the study is to determine whether aspirin alone or aspirin combined with various doses of rivaroxaban causes subclinical (i.e. without symptoms) gastrointestinal (gut) blood loss as determined by a test called the HemoQuant assay.
Following the screening visit (that occurs any day between day -30 and -1), eligible participants will undergo an approximate two-week baseline period (from day 1 to 14) (where no medication is administered) followed by an in-clinic visit between day 13 to 15 to re-confirm eligibility. Eligible participants will be randomized and study medications will be distributed at this visit. The eligible participants will then enter a two-week treatment period (from day 15-28) involving administration of aspirin either by itself or in combination with varying doses of a blood thinning agent called rivaroxaban. Stool samples will be collected twice a week throughout the baseline and treatment periods for analysis of hemoglobin (the protein in the blood that carries oxygen) with the HemoQuant assay. There is a last clinic visit at study conclusion (day 31 ± 3) to assess trial participant’s compliance with study requirements, adverse events, and lab tests.
Up to 60 participants will be randomised into one of three different arms. Each arm (of 20 subjects) will undergo an approximate two-week baseline period, followed by a two-week treatment period.
For the treatment period, Arm 1 will take 75 mg aspirin once per day, Arm 2 will take 75 mg aspirin once per day and 2.5 mg rivaroxaban twice per day, Arm 3 will take 75 mg aspirin once per day and 20 mg rivaroxaban once per day.
The total duration of study participation for each subject is approximately 31 days, excluding the screening period.REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0771
Date of REC Opinion
17 Nov 2022
REC opinion
Further Information Favourable Opinion