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Heart valve study halted early: which blood thinner is safer?

NCT ID NCT02817789

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two antiplatelet drug regimens after transcatheter aortic valve implantation (TAVI) for aortic stenosis. One group received ticagrelor alone, the other received aspirin plus clopidogrel. The goal was to see which caused fewer serious complications like bleeding, stroke, or kidney injury. However, the trial was terminated early after enrolling only 50 of the planned 308 participants, so no firm conclusions can be drawn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ticagrelor (antiplatelet drug) compared to a combination of lysine acetylsalicylate (aspirin) and clopidogrel (antiplatelet drug)
What this could lead to
If successful, this could identify a safer antiplatelet regimen after TAVI, reducing bleeding and stroke risks.
What could go wrong
The trial was terminated early with only 50 participants, so results are very limited. It is unclear if ticagrelor alone is truly safer or effective.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

50 people

The number who actually took part.

Started

May 2016

Finished

May 2018

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: * Provision of informed consent prior to any study specific procedures * Female or male aged \> 18 years * Patient eligible for TAVI as recommended by French health care system authority (HAS) Exclusion Criteria: * Allergy, hypersensitivity, or contraindication to lysine acetylsalicylate, clopidogrel, ticagrelor, any anticoagulation or magnetic resonance imaging (MRI) or CT-scanner contrast agents * Use of Cytochrome P3a (CYP3a) inhibitor * Need for chronic anticoagulation * Previous percutaneous coronary intervention or acute coronary syndrome requiring dual antiplatelet therapy * Previous cardiac surgery for valve replacement * Prior stroke, transient ischemic attack (TIA) or known carotid stenosis \> 70% * Active pathological bleeding or gastric ulcer \< 3month * Known thrombocytopenia, anemia or any coagulopathy * Severe kidney or hepatic impairment * Hemodynamic instability * Refusal of Transfusion * Significant mental impairment * Inability to give informed consent or comply with study related procedures or high likelihood of being unavailable for follow-up * Pregnant or breastfeeding women * Women of childbearing potential without effective contraception (oestroprogestative, intrauterine devices) * Participant in another investigational drug or device study.

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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

  • APHM

    Marseille, 13005, France

  • APHP

    Paris, 75013, France

  • CHRU de Lille

    Lille, 59037, France

  • CHRU de Nîmes

    Nîmes, 30029, France

  • CHU de Bordeaux

    Pessac, 33604, France

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