New trial tests if adding a blood thinner to standard care prevents heart attacks in rare artery condition
NCT ID NCT07511257
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two blood-thinning approaches in 326 adults with acute coronary syndrome and coronary artery ectasia (enlarged heart arteries). One group gets standard dual antiplatelet therapy (aspirin plus clopidogrel), while the other gets clopidogrel plus the anticoagulant rivaroxaban. The goal is to see if adding rivaroxaban reduces major heart events without causing too much bleeding.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- aspirin, clopidogrel, and rivaroxaban
- What this could lead to
- If successful, this could establish a better blood-thinning strategy to prevent heart attacks and repeat procedures in people with both acute coronary syndrome and coronary artery ectasia.
- What could go wrong
- This is a phase 4 trial, but the condition is uncommon, so results may not apply broadly. Adding anticoagulation also raises the risk of bleeding, which could outweigh the benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 326 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults aged 18 to 80 years, of either sex, hospitalized with acute coronary syndrome (ACS) with or without ST-segment elevation. * Recent ACS within 7 days prior to enrollment, defined by all of the following: * Clinical presentation consistent with acute coronary syndrome. * Elevated high-sensitivity cardiac troponin above the 99th percentile. * Presence or absence of persistent ST-segment elevation. * Coronary artery ectasia in the culprit coronary artery, defined by all of the following: * The presence of ectasia will be determined by agreement of two expert interventional cardiologists, and will be confirmed by quantitative coronary angiography (QCA). * Identification of a culprit artery consistent with the electrocardiographic territory involved (in cases with ST-segment elevation) or with angiographic features suggestive of an atherothrombotic event, such as the presence of thrombus or reduced coronary flow. * Hospital admission lasting more than 24 hours. * Management with either percutaneous coronary intervention or medical therapy, as determined by the treating medical team. Intracoronary interventions such as stent implantation, balloon angioplasty, or thrombus aspiration are permitted. * Ability and willingness to provide written informed consent and to participate in the study. Exclusion Criteria: * Pregnant women. * Current indication for temporary or long-term anticoagulation therapy at the time of enrollment. * Severe chronic kidney disease, defined as KDIGO stage G4 or higher (estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m²). * Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² at hospital discharge. * History of major bleeding, active bleeding, or high bleeding risk, including but not limited to gastrointestinal bleeding, intracranial hemorrhage, or other conditions considered by the treating physician to confer a high risk of bleeding. * Advanced heart failure, defined as left ventricular ejection fraction (LVEF) \<30% plus at least one of the following: * More than two hospitalizations or unplanned emergency department visits for heart failure in the past year, or * NYHA functional class III or IV symptoms despite optimal medical therapy at enrollment or within the previous 3 months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Instituto Nacional de Cardiologia "Ignacio Chávez"
RECRUITINGMexico City, Tlalpan, 14080, Mexico
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