An observational study in Gastrointestinal Bleeding, Antiplatelet Agents and Oral Anticoagulant Therapy, sponsored by Jordan Collaborating Cardiology Group. Not yet recruiting at 1 site in Jordan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Jordan Collaborating Cardiology Group · Observational
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.
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.
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.
Exclusion Criteria:
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.
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.
Time frame: 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
Time frame: From enrollment to the end of the study at 3 months
Plan to share: Yes — The variables collected for each study participant will be provided upon request from the primary investigator including the baseline clinical features and lab results.
Supporting information: Study protocol, Sap, Icf, Csr
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This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Jordan Collaborating Cardiology Group