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

NCT ID: NCT07327853

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2027-04-30

Brief 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

Gastrointestinal Bleeding; Antiplatelet Agents; Oral Anticoagulant Therapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients to be prescribed oral antiplatelet and/or anticoagulant medications

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.

Fecal Immunochemical Test (FIT)

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

Fecal 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jordan Collaborating Cardiology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istishari hospital

Amman, , Jordan

Countries

Jordan

Central Contacts

Ahmad Qarqash, MD

Role: CONTACT

researchculture2020@gmail.com

+9625001000

Facility Contacts

Ayman Hammoudeh, MD, FACC

Role: primary

hammoudeh_ayman@yahoo.com

+962795222802

Other Identifiers

FIT/AP/AC#1.28.12.25

Identifier Type: -

Identifier Source: org_study_id