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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Antiplatelet Agents; Gastrointestinal Bleeding; Oral Anticoagulant Therapy
• Intervention / Treatment: Diagnostic test: Fecal Immunochemical Test (FIT)

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Ahmad Qarqash, MD; Phone Number: +9625001000; Email: researchculture2020@gmail.com

Study Locations

• Jordan
  • Amman, Jordan, 11184
    • Istishari Hospital
    • Contact: Ayman Hammoudeh, MD, FACC; Phone Number: +962795222802; Email: hammoudeh_ayman@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the time of enrollment to the end of the study at 3 months
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	From enrollment to the end of the study at 3 months

Collaborators and Investigators

• Sponsor: Jordan Collaborating Cardiology Group

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: December 25, 2025
• First Submitted That Met QC Criteria: December 25, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 25, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Gastrointestinal bleeding; Antiplatelet agents; Occult fecal blood; Fecal Immunochemical Test (FIT); Oral anticoagulant agents
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Gastrointestinal Hemorrhage
• Other Study ID Numbers: FIT/AP/AC#1.28.12.25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The variables collected for each study participant will be provided upon request from the primary investigator including the baseline clinical features and lab results.
• IPD Sharing Time Frame: April 2027 to December 2027
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No