Heart valve study halted early: which blood thinner is safer?
NCT ID NCT02817789
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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50 people
The number who actually took part.
- Started
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May 2016
- Finished
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May 2018
- 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 years and older
- 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.
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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
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APHM
Marseille, 13005, France
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APHP
Paris, 75013, France
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CHRU de Lille
Lille, 59037, France
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CHRU de Nîmes
Nîmes, 30029, France
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CHU de Bordeaux
Pessac, 33604, France
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