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Heart study tests Lower-Dose blood thinner and new stents for better safety

NCT ID NCT02193971

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.