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

NCT07327853 | Not Yet Recruiting DMC

• 1 other identifier: FIT/AP/AC#1.28.12.25
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Bleeding; Antiplatelet Agents; Oral Anticoagulant Therapy

Keywords

Occult fecal blood; Fecal Immunochemical Test (FIT); Gastrointestinal bleeding; Antiplatelet agents; Oral anticoagulant agents; Cardiovascular disease

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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)

Interventions

Fecal Immunochemical Test (FIT) 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.

Patients to be prescribed oral antiplatelet and/or anticoagulant medications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jordan Collaborating Cardiology Group: lead

Study Sites (1)

Istishari hospital

Amman, 11184, Jordan

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ahmad Qarqash, MD

CONTACT

+9625001000; researchculture2020@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 8, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: April 2027 to December 2027

Locations

JO (1)