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

Jordan Collaborating Cardiology Group

Status: Not yet enrolling

Conditions: Antiplatelet Agents; Oral Anticoagulant Therapy; Gastrointestinal Bleeding

Treatments: Diagnostic Test: Fecal Immunochemical Test (FIT)

Study type: Observational

Funder types: Other

Identifiers

NCT07327853

FIT/AP/AC#1.28.12.25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).
• Agrees to sign the informed consent.

Exclusion criteria

• Presence of past bleeding tendency of gastrointestinal disease.
• Refusal to have the test done (FIT).
• Refusal to sign the informed consent.

Trial design

200 participants in 1 patient group

Patients to be prescribed oral antiplatelet and/or anticoagulant medications

Description:

The patients will have FIT performed before initiation of the oral antiplatelet and/or anticoagulant medications. Those with negative result will be followed up for 3 months after starting the medications and the FIT will be repeated. If the test turns positive, the patient will be referred for further evaluation be a gastroenterologist.

Treatment:

Diagnostic Test: Fecal Immunochemical Test (FIT)