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NCT Number: NCT07327853

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Positive Fecal Immunochemical Test

    Time frame: From the time of enrollment to the end of the study at 3 months

    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.

  2. Positive Fecal Immunochemical Test (FIT)

    Time frame: From enrollment to the end of the study at 3 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmad Qarqash, MD

CONTACT

[email protected]

+9625001000

Sponsors and collaborators

Lead sponsor

Jordan Collaborating Cardiology Group

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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