Heart study tests Lower-Dose blood thinner and new stents for better safety
NCT ID NCT02193971
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at over 3,400 people with acute coronary syndrome (a heart attack or unstable angina) who received a stent to open blocked arteries. Researchers compared two types of stents (biostable vs. biodegradable polymer) and two doses of the blood thinner prasugrel (5 mg vs. 10 mg daily). The goal was to see if the newer stents and lower dose are as effective and safer than the standard options.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Prasugrel (blood thinner) and drug-eluting stents (medical devices)
- What this could lead to
- If successful, this could show that a lower dose of prasugrel is just as safe and effective as the standard dose, and that one type of stent is better than another for heart patients.
- What could go wrong
- This is a completed Phase 4 trial, so results are already in. However, the findings may not apply to all heart patients, and individual risks like bleeding or stent complications remain.
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
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
3,429 people
The number who actually took part.
- Started
-
Jul 2014
- Finished
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Jan 2024
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * Subject must be ≥ 18 years * Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. * Subject must have a culprit lesion in a native coronary artery with significant stenosis (\>50% by visual estimate) eligible for stent implantation * Subject must have clinical diagnosis of acute coronary syndrome Exclusion Criteria: * Following patients will be enrolled in stent comparison, but excluded from antiplatelet comparison. They will be classified as observational cohort. * Subjects ≥75 years * Body weight \<60 kg * History of TIA or stroke * The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Biolimus, Everolimus, Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.) * Patients with active pathologic bleeding * Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months. * Systemic (intravenous) Biolimus, or everolimus use within 12 months. * Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study. * History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions * Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
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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.
Contacts and locations
Locations
-
Seoul National University Hospital
Seoul, 110-744, South Korea
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