Healthy VolunteerNCT05546957
Assess Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban in Healthy Adult Participants
A study testing Aspirin, rivaroxaban low dose and rivaroxaban high dose in people with Healthy Volunteer, run by Regeneron Pharmaceuticals at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Aspirin, rivaroxaban low dose and rivaroxaban high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jan 2023to 6 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has a body mass index between 18 and 32 kilograms per metered square (kg/m2), inclusive
- 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
- Is in good health based on laboratory safety testing obtained at the screening visit
- Willing and able to abstain from alcohol use for the duration of the study
Who cannot join
- 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
- 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
- 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
- Inability to refrain during study period from activities with high risk of bleeding or trauma such as planned surgery, contact sports, etc.
- Hemoglobin levels below the lower limit of normal as defined by local laboratory at screening; the lab may be repeated once if initially abnormal
- 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
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- 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
- 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
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Volunteer
- Being tested
- Aspirin, rivaroxaban low dose, rivaroxaban high dose
- Keywords
- No gastrointestinal (GI) disease, No risk factors for bleeding, Direct oral anticoagulant (DOAC), Fecal occult blood testing (FOBT)
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Administered orally once per day (QD)
rivaroxaban low doseDrug
Administered orally twice per day (BID)
rivaroxaban high doseDrug
Administered orally QD
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Aspirin QD | Experimental | Randomized 1:1:1 Receives: Drug: Aspirin |
| Arm 2: Aspirin QD + rivaroxaban BID | Experimental | Randomized 1:1:1 Receives: Drug: Aspirin; Drug: rivaroxaban low dose |
| Arm 3: Aspirin QD + rivaroxaban QD | Experimental | Randomized 1:1:1 Receives: Drug: Aspirin; Drug: rivaroxaban high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Week 4
Secondary outcomes (1)
Number of bleeding events during the baseline period as compared to the treatment period
Measured: Up to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start5 Jan 2023
- Primary completion6 Apr 2023
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546957
- Sponsor's protocol ID
- R0000-HV-2229
- Other IDs
- 2022-002761-15
- Status last verified
- May 2023
- First submitted
- 15 Sep 2022
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05546957
- Acronym / sponsor ID
- R0000-HV-2229
- Conditions
- Healthy Volunteer
- Keywords
- No gastrointestinal (GI) disease, No risk factors for bleeding, Direct oral anticoagulant (DOAC), Fecal occult blood testing (FOBT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Aspirin QD | Experimental | Drug: AspirinRandomized 1:1:1 |
| Arm 2: Aspirin QD + rivaroxaban BID | Experimental | Drug: Aspirin, Drug: rivaroxaban low doseRandomized 1:1:1 |
| Arm 3: Aspirin QD + rivaroxaban QD | Experimental | Drug: Aspirin, Drug: rivaroxaban high doseRandomized 1:1:1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Has a body mass index between 18 and 32 kilograms per metered square (kg/m2), inclusive
- 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
- Is in good health based on laboratory safety testing obtained at the screening visit
- Willing and able to abstain from alcohol use for the duration of the study
Key exclusion criteria (12 listed)
- 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
- 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
- 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
- Inability to refrain during study period from activities with high risk of bleeding or trauma such as planned surgery, contact sports, etc.
- Hemoglobin levels below the lower limit of normal as defined by local laboratory at screening; the lab may be repeated once if initially abnormal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAdministered orally once per day (QD) | Drug | Arm 1: Aspirin QD, Arm 2: Aspirin QD + rivaroxaban BID, Arm 3: Aspirin QD + rivaroxaban QD |
| rivaroxaban low doseAdministered orally twice per day (BID) | Drug | Arm 2: Aspirin QD + rivaroxaban BID |
| rivaroxaban high doseAdministered orally QD | Drug | Arm 3: Aspirin QD + rivaroxaban QD |
Primary outcome
Change from baseline in fecal hemoglobin content as measured by HemoQuant during the second week of exposure to study medication
Time frame: Up to Week 4
HemoQuant is a chemical laboratory test of fecal hemoglobin content.
1 secondary outcome
Number of bleeding events during the baseline period as compared to the treatment period
Time frame: Up to week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin, rivaroxaban low dose and rivaroxaban high dose in people with Healthy Volunteer, run by Regeneron Pharmaceuticals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in fecal hemoglobin content as measured by HemoQuant during the second week of exposure to study medication (time frame: Up to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.