How Often Does the Fecal Test for Occult Blood Turn Positive After Using Blood Thinners?
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJordan Collaborating Cardiology Group
About this trial
Blood thinner medications used for cardiovascular disease can cause gastrointestinal bleeding. Early detection of invisible bleeding by performing occult fecal blood test (called fecal immunochemical test, or FIT) can uncover serious disease in the stomach and intestine and enable the treating physician to refer the patient for further evaluation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Have an indication to use oral antiplatelet or anticoagulant agent(s).
Absence of past bleeding tendency of gastrointestinal disease.
Agrees to have the test done (FIT).
Disqualifiers
Presence of past bleeding tendency of gastrointestinal disease.
Refusal to have the test done (FIT).
Refusal to sign the informed consent.
Trial population
The patients to be included in the study are those who will be prescribed oral antiplatelet or anticoagulant (AP/AC) agents for a cardiovascular indication. They also should have no prior gastrointestinal disease. These patients will be evaluated over a period of 3 months after starting the AP/AC medication for the potential occurrence of occult gastrointestinal bleeding utilizing the fecal immunochemical test.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Fecal Immunochemical Test (FIT)
Diagnostic testA stool sample will be tested by the FIT test to examine the presence or absence of fecal occult blood. Each participant will be tested twice; one before starting the oral antiplatelet or anticoagulant agents and the second 3 months after the use of the medication.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Patients to be prescribed oral antiplatelet and/or anticoagulant medications1 intervention
Trial outcomes
Primary outcomes
1
Positive Fecal Immunochemical Test
A fecal specimen from each study participant will be tested for the presence or absence of fecal occult blood. This test will be performed before starting the oral antiplatelet or anticoagulant agents and will be repeated 3 months later.
Time frame
From the time of enrollment to the end of the study at 3 months2
Positive Fecal Immunochemical Test (FIT)
Positive Fecal Immunochemical Test (FIT) implies that the fecal sample obtained from each participant contains occult blood, denoting a bleeding source in the gastrointestinal system
Time frame
From enrollment to the end of the study at 3 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: