Gastric Bypass StatusPhase 1NCT02058199
Rivaroxaban Effects in Subjects Who Have Undergone Gastric Bypass Surgery
A Phase 1 study testing rivaroxaban in people with Gastric Bypass Status, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
The investigators are attempting to compare the anticoagulant (blood thinning) effects of a recently FDA approved medication, Rivaroxaban, in people who have undergone gastric bypass surgery to people who have not had this surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Bypass Status
- What is being tested?
- rivaroxaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2015
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers in one of four groups
- Normal weight and not having prior gastric bypass surgery,
- Obese and not having prior gastric bypass surgery,
- Subjects with prior roux en Y gastric bypass surgery,
- Obese and planning to undergo roux en Y gastric bypass
Who cannot join
- Active renal or liver disease,
- bleeding diathesis,
- concurrent treatment with anticoagulants or aspirin,
- indication for aspirin or anticoagulant treatment,
- gastrointestinal bleeding,
- uncontrolled hypertension,
Show all 12Show fewer
- active malignancy,
- anemia,
- thrombocytopenia,
- pregnant,
- allergy to rivaroxaban,
- coagulopathy or any other medical condition that would increase risk to the subject
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: A Pharmacodynamic Study of Rivaroxaban in Subjects Who Have Undergone Roux-en-Y Gastric Bypass Surgery
The investigators are attempting to compare the anticoagulant (blood thinning) effects of a recently FDA approved medication, Rivaroxaban, in people who have undergone gastric bypass surgery to people who have not had this surgery. It is thought that gastric bypass may alter the absorption of this medication, but this has not been previously studied.
The investigators will study the anticoagulant effect of rivaroxaban in healthy volunteers who are in one of four groups
Read more
- Non obese people who have not had a gastric bypass.
- Obese people who have not had a gastric bypass
- People who have had a gastric bypass
- People who are planning to undergo gastric bypass surgery in the near future who are willing to be studied before and after the bypass.
The study will involve taking a single low dose of rivaroxaban and multiple blood samples will be taken over the next 24 hours and the effect of rivaroxaban on blood clotting will be measured using the prothrombin time and an anti-factor Xa assay. The effects of rivaroxaban will be compared between the different groups.
- Conditions
- Gastric Bypass Status
- Being tested
- rivaroxaban
- Keywords
- gastric bypass, rivaroxaban, pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rivaroxabanDrug
Also called Xarelto
Single dose pharmacodynamic study
| Study group | Role | What they receive |
|---|---|---|
| normal subjects | Experimental | A single dose of 10 mg of rivaroxaban will be administered Receives: Drug: rivaroxaban |
| Obese non bypassed | Experimental | A single dose of rivaroxaban will be administered Receives: Drug: rivaroxaban |
| obese bypassed | Experimental | A single dose of rivaroxaban will be administered Receives: Drug: rivaroxaban |
| pre and post bypassed subject | Experimental | A single dose of rivaroxaban will be administered prior to gastric bypass. Subjects will be restudied 12 to 24 weeks following bypass Receives: Drug: rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
median inhibition of factor xa inhibition
pharmacodynamic
Measured: 24 hours
Secondary outcomes (1)
median prolongation of prothrombin time
pharmacodynamic
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: PI left the Institution; No replacement PI identified;
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Bypass StatusStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas E Coyle, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058199
- Sponsor's protocol ID
- SUNYUMU-rivpd-001
- Status last verified
- Jan 2015
- First submitted
- 6 Feb 2014
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacodynamic Study of Rivaroxaban in Subjects Who Have Undergone Roux-en-Y Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT02058199
- Acronym / sponsor ID
- SUNYUMU-rivpd-001
- Conditions
- Gastric Bypass Status
- Keywords
- gastric bypass, rivaroxaban, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the Institution; No replacement PI identified;
- Enrolment
- 2 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Feb 2014 (estimated)
- 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 investigators are attempting to compare the anticoagulant (blood thinning) effects of a recently FDA approved medication, Rivaroxaban, in people who have undergone gastric bypass surgery to people who have not had this surgery. It is thought that gastric bypass may alter the absorption of this medication, but this has not been previously studied.
The investigators will study the anticoagulant effect of rivaroxaban in healthy volunteers who are in one of four groups
- Non obese people who have not had a gastric bypass.
- Obese people who have not had a gastric bypass
- People who have had a gastric bypass
- People who are planning to undergo gastric bypass surgery in the near future who are willing to be studied before and after the bypass.
The study will involve taking a single low dose of rivaroxaban and multiple blood samples will be taken over the next 24 hours and the effect of rivaroxaban on blood clotting will be measured using the prothrombin time and an anti-factor Xa assay. The effects of rivaroxaban will be compared between the different groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normal subjects | Experimental | Drug: rivaroxabanA single dose of 10 mg of rivaroxaban will be administered |
| Obese non bypassed | Experimental | Drug: rivaroxabanA single dose of rivaroxaban will be administered |
| obese bypassed | Experimental | Drug: rivaroxabanA single dose of rivaroxaban will be administered |
| pre and post bypassed subject | Experimental | Drug: rivaroxabanA single dose of rivaroxaban will be administered prior to gastric bypass. Subjects will be restudied 12 to 24 weeks following bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy volunteers in one of four groups
Key exclusion criteria (12 listed)
- Active renal or liver disease,
- bleeding diathesis,
- concurrent treatment with anticoagulants or aspirin,
- indication for aspirin or anticoagulant treatment,
- gastrointestinal bleeding,
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 |
|---|---|---|
| rivaroxabanAlso: XareltoSingle dose pharmacodynamic study | Drug | Obese non bypassed, normal subjects, obese bypassed, pre and post bypassed subject |
Primary outcome
median inhibition of factor xa inhibition
Time frame: 24 hours
pharmacodynamic
1 secondary outcome
median prolongation of prothrombin time
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: PI left the Institution; No replacement PI identified;). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
Related trials for Gastric Bypass Status
Recruiting
Gestational Diabetes After Gastric Bypass Surgery
Diabetes, Gestational, Gastric Bypass Status for Obesity Complicating Pregnancy, Childbirth, or the Puerperium
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.
Thomas E Coyle, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rivaroxaban in people with Gastric Bypass Status, run by State University of New York - Upstate Medical University at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 5 Jan 2016. 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 States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI left the Institution; No replacement PI identified;). Results are not available in the source record.
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?
median inhibition of factor xa inhibition (time frame: 24 hours). 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 5 Jan 2016; AzTrials last refreshed its copy on 8 Nov 2026.