Gastrointestinal BleedingNCT07327853
How Often Does the Fecal Test for Occult Blood Turn Positive After Using Blood Thinners?
An observational study of Gastrointestinal Bleeding and Antiplatelet Agents, run by Jordan Collaborating Cardiology Group at 1 site in Jordan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Bleeding, Antiplatelet Agents, Oral Anticoagulant Therapy
- What is being tested?
- Fecal Immunochemical Test (FIT)
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteJordan
- Study dates
- 1 Feb 2026to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Presence of past bleeding tendency of gastrointestinal disease.
- Refusal to have the test done (FIT).
- Refusal to sign the informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site
Istishari hospital
Amman, 11184
Ayman Hammoudeh, MD, FACC, +962795222802, hammoudeh_ayman@yahoo.com
About this study
Official title: Exploring the Prevalence and Potential Benefits of Fecal Immunochemical Test Before Ana After Use of Antiplatelet and Anticoagulant Agents
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.
Read the 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.
- Being tested
- Fecal Immunochemical Test (FIT)
- Keywords
- Occult fecal blood, Fecal Immunochemical Test (FIT), Gastrointestinal bleeding, Antiplatelet agents, Oral anticoagulant agents, Cardiovascular disease
- Medical subject headings
- Gastrointestinal Hemorrhage, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Fecal Immunochemical Test (FIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From enrollment to the end of the study at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327853
- Sponsor's protocol ID
- FIT/AP/AC#1.28.12.25
- Status last verified
- Dec 2025
- First submitted
- 25 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Prevalence and Potential Benefits of Fecal Immunochemical Test Before Ana After Use of Antiplatelet and Anticoagulant Agents
- ClinicalTrials.gov ID
- NCT07327853
- Acronym / sponsor ID
- FIT/AP/AC#1.28.12.25
- Keywords
- Occult fecal blood, Fecal Immunochemical Test (FIT), Gastrointestinal bleeding, Antiplatelet agents, Oral anticoagulant agents, Cardiovascular disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients to be prescribed oral antiplatelet and/or anticoagulant medications | – | Diagnostic Test: Fecal Immunochemical Test (FIT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Presence of past bleeding tendency of gastrointestinal disease.
- Refusal to have the test done (FIT).
- Refusal to sign the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Patients to be prescribed oral antiplatelet and/or anticoagulant medications |
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Bleeding and Antiplatelet Agents, run by Jordan Collaborating Cardiology Group at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmad Qarqash, MD (+9625001000, researchculture2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Fecal Immunochemical Test (time frame: From the time of enrollment to the end of the study at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.