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

NCT05546957 | Completed

• 2 other identifiers: R0000-HV-22292022-002761-15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Keywords

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

Outcome Measures

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.

  Up to Week 4

Secondary Outcomes (1)

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

  Up to week 4

Study Arms (3)

Arm 1: Aspirin QD

EXPERIMENTAL

Randomized 1:1:1

Drug: Aspirin

Arm 2: Aspirin QD + rivaroxaban BID

EXPERIMENTAL

Randomized 1:1:1

Drug: Aspirin; Drug: rivaroxaban low dose

Arm 3: Aspirin QD + rivaroxaban QD

EXPERIMENTAL

Randomized 1:1:1

Drug: Aspirin; Drug: rivaroxaban high dose

Interventions

Aspirin DRUG

Administered orally once per day (QD)

Arm 1: Aspirin QD; Arm 2: Aspirin QD + rivaroxaban BID; Arm 3: Aspirin QD + rivaroxaban QD

rivaroxaban low dose DRUG

Administered orally twice per day (BID)

Arm 2: Aspirin QD + rivaroxaban BID

rivaroxaban high dose DRUG

Administered orally QD

Arm 3: Aspirin QD + rivaroxaban QD

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

LabCorp CRU

Leeds, West Yorkshire, LS2 9LH, United Kingdom

Location

MeSH Terms

Conditions

Disease

Interventions

Aspirin; Rivaroxaban

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Thiophenes; Sulfur Compounds; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 21, 2022
• Study Start: January 5, 2023
• Primary Completion: April 6, 2023
• Study Completion: April 6, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

GB (1)