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Not yet recruiting NCT07327853

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

Observational Gastrointestinal Bleeding Antiplatelet Agents Oral Anticoagulant Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fecal Immunochemical Test (FIT).
Who it may be relevant to
Registry conditions: Gastrointestinal Bleeding, Antiplatelet Agents, Oral Anticoagulant Therapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Jordan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Positive Fecal Immunochemical Test [Time frame: From the time of enrollment to the end of the study at 3 months]
  • Positive Fecal Immunochemical Test (FIT) [Time frame: From enrollment to the end of the study at 3 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Jordan · 1 center
  • Istishari hospital — Amman

Identifiers

NCT: NCT07327853 · FIT/AP/AC#1.28.12.25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗