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CompletedNCT05546957Updated May 24, 2023

Assess Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban in Healthy Adult Participants

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

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteer

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Keywords

  • No gastrointestinal (GI) disease
  • No risk factors for bleeding
  • Direct oral anticoagulant (DOAC)
  • Fecal occult blood testing (FOBT)
03

In context

Hemorrhage

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  1. Has a body mass index between 18 and 32 kilograms per metered square (kg/m2), inclusive
  2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed during screening
  3. Is in good health based on laboratory safety testing obtained at the screening visit
  4. Willing and able to abstain from alcohol use for the duration of the study

Key Exclusion Criteria:

  1. History of anemia, abnormal bleeding (including vaginal bleeding or excessive menstrual periods), previous diagnosis of bleeding diathesis, or blood clots as defined in the protocol
  2. History, in the last year, of any bleeding GI lesions such as peptic ulcer, hemorrhoids or anal fissure, or a positive fecal occult blood test performed either during screening or on Day 1
  3. Presence of irregular stool patterns, constipation, or frequent diarrhea that, in the opinion of the investigator, may interfere with stool collections required by the protocol
  4. Inability to refrain during study period from activities with high risk of bleeding or trauma such as planned surgery, contact sports, etc.
  5. Hemoglobin levels below the lower limit of normal as defined by local laboratory at screening; the lab may be repeated once if initially abnormal
  6. PT and aPTT values above the upper limit of normal as defined by the local laboratory during screening; the lab may be repeated once if initially abnormal
  7. Platelet count below the lower limit of normal as defined by the local laboratory during screening; the lab may be repeated once if initially abnormal
  8. 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

  9. Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
  10. Has received a COVID-19 vaccination within 1 week of day 1 of the study or for which the planned COVID-19 vaccinations would not be completed 1 week prior to day 1 of the study.

NOTE: Other protocol defined inclusion / exclusion criteria apply.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Arm 1: Aspirin QD

    Randomized 1:1:1

    Drug: Aspirin

  • Experimental
    Arm 2: Aspirin QD + rivaroxaban BID

    Randomized 1:1:1

    Drug: Aspirin · Drug: rivaroxaban low dose

  • Experimental
    Arm 3: Aspirin QD + rivaroxaban QD

    Randomized 1:1:1

    Drug: Aspirin · Drug: rivaroxaban high dose

Interventions

  • DrugAspirin

    Administered orally once per day (QD)

  • Drugrivaroxaban low dose

    Administered orally twice per day (BID)

  • Drugrivaroxaban high dose

    Administered orally QD

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of bleeding events during the baseline period as compared to the treatment period

    Time frame: Up to week 4

07

Study locations

1 site
  • LabCorp CRU
    Leeds, West Yorkshire LS2 9LH, United Kingdom
08

References and documents

Individual participant data

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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05546957
Lead sponsor
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 21, 2022
Start date
Jan 5, 2023
Primary completion
Apr 6, 2023
Completion
Apr 6, 2023
Last update
May 24, 2023

Study contacts

Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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