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Not Yet RecruitingNCT07327853

How Often Does the Fecal Test for Occult Blood Turn Positive After Using Blood Thinners?

Exploring the Prevalence and Potential Benefits of Fecal Immunochemical Test Before Ana After Use of Antiplatelet and Anticoagulant Agents

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
Jordan Collaborating Cardiology Group · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

Oral anticoagulant and antiplatelet agents (AC/AP agents) are the cornerstone of treatment in patients with cardiovascular disease (CVD), including those with coronary artery disease, atrial fibrillation and deep vein thrombosis/pulmonary embolism. However, these agents are associated with risk of gastrointestinal (GI) bleeding. The bleeding can unmask certain GI pathologies early such as peptic ulcer disease, polyps and cancer. The fecal immunochemical test (FIT) is the most commonly used test utilized in clinical practice to detect occult fecal blood. There is scarcity of studies in the Middle East that evaluate the frequency of positive FIT in patients with CVD prescribed AC/AP agents with an initially negative FIT and who do not have history of bleeding or GI disease. The concept of the study relies on performing FIT before AC/AP initiation, and if negative, the test will be repeated after 3 months. If the repeat test turns positive , these patients will be referred for further GI evaluation.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTFecal Immunochemical Test (FIT)A 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.

Timeline

Start date
2026-02-01
Primary completion
2026-12-31
Completion
2027-04-30
First posted
2026-01-08
Last updated
2026-01-08

Locations

1 site across 1 country: Jordan

Source: ClinicalTrials.gov record NCT07327853. Inclusion in this directory is not an endorsement.