Phase 4 Heart Disease Trial, Recruiting NCT04416581 Sponsor: Duk-Woo Park, MD Condition: Heart Disease
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Phase 4 Heart Disease Trial, Recruiting

NCT04416581
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 19 or older who have a known heart or blood vessel condition and are currently taking long-term blood-thinning medicines (such as blood clot prevention tablets or blood thinners taken by mouth). Qualifying conditions may include coronary artery disease, a history of heart attack or chest pain, a history of stroke or mini-stroke, peripheral artery disease, atrial fibrillation, or a heart valve condition treated with a procedure
  • People who are considered at higher risk of bleeding in the stomach or gut, meaning they meet at least one of the following: aged 65 or older; currently taking both a blood thinner and an antiplatelet medicine together; long-term or high-dose use of anti-inflammatory painkillers (such as ibuprofen) or steroids; a past episode of stomach or gut bleeding; a history of a complicated stomach ulcer; a history of peptic ulcer disease or an uncomplicated stomach ulcer; or a confirmed Helicobacter pylori infection (a type of stomach bacteria)
  • People who give their written consent to take part voluntarily

Who may not be able to join:

  • People who are actively bleeding at the time of enrolment, or who have a condition — inherited or acquired — that affects normal blood clotting
  • People who have a medical reason why they cannot take blood-thinning medicines
  • People who have taken a proton pump inhibitor (a type of stomach acid medicine) or a related medicine called P-CAB within the 4 weeks before joining the trial
  • People whose heart condition is severely unstable at the time of enrolment, such as being in cardiogenic shock, having uncontrolled dangerous heart rhythms, or having the most severe stage of heart failure
  • People with severely low red blood cell levels (anaemia) at the start of the trial, or who have received a blood transfusion within the 4 weeks before joining
  • People with a severely low platelet count (platelets are cells that help blood clot) at the start of the trial
  • People whose kidneys are functioning very poorly and who require dialysis, or whose kidney function is severely reduced
  • People with severe chronic liver disease, including conditions such as liver-related fluid build-up, liver-related confusion, yellowing of the skin, or bleeding from veins in the throat caused by liver disease
  • People who are allergic to or cannot safely take the stomach acid medicines being studied, or related medicines
  • People who are allergic to the antibiotic clarithromycin or a related class of antibiotics, where that antibiotic is being used to treat H. pylori infection
  • People who are taking clarithromycin for H. pylori treatment alongside certain other medicines (terfenadine, cisapride, astemizole, or pimozide) due to dangerous interactions
  • People taking strong medicines that interfere with how the body breaks down certain drugs — for example, certain antifungal medicines (such as ketoconazole) or certain HIV medicines (such as ritonavir)
  • People who are taking the HIV medicines atazanavir, nelfinavir, or rilpivirine-containing products
  • People with significantly abnormal blood test results at the start of the trial, including very low kidney filtration rates or liver enzyme levels more than three times the upper limit of normal — or any other condition the trial investigator considers would prevent safe participation
  • People with any known or suspected cancer
  • People who have a non-heart-related illness where life expectancy is estimated at less than 12 months
  • People who are currently being treated for an active H. pylori infection
  • Women who are pregnant or breastfeeding; premenopausal women who have not had surgical sterilisation and who — if sexually active — are not using an effective form of contraception throughout the study; or women of childbearing potential who have a positive pregnancy test at the screening stage
  • People who have taken part in another clinical trial within the past 12 months (though exceptions may be considered by the trial investigator in certain situations, such as having only participated in an observational study, having been screened but not enrolled in another trial, or having taken part in a study involving only standard care with no added risk — confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: 82230107259

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Duk-Woo Park, MD
Registry
ClinicalTrials.gov
Start date
12 May 2021
Est. completion
31 December 2027

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

The time from randomization to the first occurrence of a composite endpoint of upper GI clinical events, including during the treatment period

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov