Antiplatelet Agents, Gastrointestinal Bleeding, Oral Anticoagulant Therapy
Conditions
Keywords
Occult fecal blood, Fecal Immunochemical Test (FIT), Gastrointestinal bleeding, Antiplatelet agents, Oral anticoagulant agents, Cardiovascular disease
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.
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_TESTFecal 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.
Sponsors
Jordan Collaborating Cardiology Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Fecal Immunochemical Test | 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. |
| Positive Fecal Immunochemical Test (FIT) | 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 |
Countries
Jordan
Contacts
Primary ContactAhmad Qarqash, MD
Outcome results
None listed