Phase 4 Heart Disease Trial, Recruiting NCT05491200 Sponsor: Research Maatschap Cardiologen Rotterdam Zuid Condition: Heart Disease
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Phase 4 Heart Disease Trial, Recruiting

NCT05491200
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 who have had a heart attack (specifically a type called STEMI) and are planned to have a procedure to open a blocked artery (called PCI or stent placement)
  • People whose heart attack is confirmed by at least 20 minutes of chest discomfort at rest, along with specific changes seen on a heart tracing (ECG) — either elevation in certain areas of the ECG, or a new abnormal electrical pattern in the heart
  • People who, at a follow-up visit between 30 and 45 days after the procedure, have been consistently taking their two blood-thinning medications as prescribed with no changes to the regimen
  • People who have not experienced a serious health event (such as another heart attack, unplanned repeat procedure, stroke, or major bleeding) between their procedure and the 30–45 day follow-up visit
  • People whose stent procedure was considered technically successful, with the treated artery showing less than 30% blockage remaining
  • People who have had all significant blockages treated — either during the main procedure or in follow-up procedures within 15 days

Who may not be able to join:

  • People who are already taking blood-thinning tablets (oral anticoagulants)
  • People who cannot safely take certain blood-thinning medications due to allergies or medical history — including people who have had a stroke or mini-stroke in the last 12 months, have active bleeding problems, severe liver disease, certain types of asthma triggered by pain-relief medicines, stomach ulcers or perforations, severe heart failure, or who take a high-dose chemotherapy drug called methotrexate
  • People taking certain medications that interact with the trial drug (confirm with trial site for the full list, which includes some antifungal, antibiotic, HIV, and seizure medications, as well as large amounts of grapefruit juice)
  • People with a very low platelet count (below 100,000 per microlitre) at the time of screening
  • People with low haemoglobin (below 10 g/dL, a measure of anaemia) at the time of screening
  • People with other serious illnesses where life expectancy is estimated to be less than one year
  • People who are pregnant, have given birth in the last 90 days, or are currently breastfeeding
  • People having the stent procedure specifically because a previous stent has clotted, or who have a confirmed history of stent clotting
  • People who need major surgery that cannot be delayed while on dual blood-thinning medication after the procedure
  • People who are in cardiogenic shock (when the heart is too weak to pump enough blood to the body)
  • People who had a cardiac arrest outside of hospital, unless they recovered quickly with a normal heart rhythm restored promptly
  • People with severely reduced kidney function (confirm specific measurement threshold with trial site)
  • People who have taken part in another clinical trial involving a device or drug in the past 12 months, or who received an experimental drug in the 30 days before screening (or longer, depending on the drug)
  • People who have not given informed consent to participate

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 13 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

Principal Investigator: Valeria Paradies, MD, PhD, Research Maatschap Cardiologen Rotterdam Zuid

Phone: +31621620153

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

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Research Maatschap Cardiologen Rotterdam Zuid
Registry
ClinicalTrials.gov
Start date
22 July 2022
Est. completion
1 August 2027

Where this trial is recruiting

🇧🇪 Belgium 🇨🇿 Czechia 🇩🇪 Germany 🇮🇹 Italy 🇳🇱 Netherlands 🇷🇸 Serbia

Primary endpoints

non inferiority of a Prasugrel-based short DAPT (30-45 days) followed by Prasugrel 11 month monotherapy versus standard 12 month DAPT regimen; superiority of an Optical Coherence Tomography (OCT)-guided revascularization completion as compared to a standard angiography-guided revascularization completion.

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: 13 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