Aortic Valve StenosisPhase 3TICTAVINCT02817789
Safety Profile Evaluation of TICagrelor Alone Compared to a Combination of Lysine Acetylsalicylate-Clopidogrel in the Context of Transcatheter Aortic Valve Implantation (TAVI)
A Phase 3 study testing Ticagrelor alone and Combination lysine acetylsalicylate - clopidogrel in people with Aortic Valve Stenosis, run by University Hospital, Bordeaux at 5 sites in France.
Trial summary
Transcatheter Aortic Valve Implantation (TAVI) is now the method of choice to treat aortic stenosis in old and frail patients. Antiplatelet therapy must be associated for the procedure and during few weeks after implantation in the aim to minimize cerebral embolization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Ticagrelor alone and Combination lysine acetylsalicylate - clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesFrance
- Study dates
- 9 May 2016to 30 May 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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%
Show all 16Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHRU de Lille
Lille, 59037
APHM
Marseille, 13005
CHRU de Nîmes
Nîmes, 30029
APHP
Paris, 75013
CHU de Bordeaux
Pessac, 33604
About this study
Transcatheter Aortic Valve Implantation (TAVI) is now the method of choice to treat aortic stenosis in old and frail patients. Antiplatelet therapy must be associated for the procedure and during few weeks after implantation in the aim to minimize cerebral embolization. But for now, the best antiplatelet regimen has to be determined. In this context, investigators want to evaluate the safety of use of ticagrelor alone versus standardized therapy which involves lysine acetylsalicylate and clopidogrel. In this study, we will randomly compare 154 patients in each group in terms of early safety (30 days) after the procedure.
Read the detailed description
In spite of the use of the combination of lysine acetylsalicylate and clopidogrel during and after the procedure of TAVI, rates of stroke remains high, between 4 and 10% regarding the studies and registries. None of the therapeutics have regulatory authorisation for this indication. On the other hand, the rates of bleeding events are also high in this old and frail population. That is why, considering its pharmacological specificity, investigators hypothesize that ticagrelor, used alone, could be non-inferior on safety criteria than the combination of lysine acetylsalicylate and clopidogrel. Our study want to evaluate the safety profile of Ticagrelor alone (180 mg loading dose before intervention and 90 mg twice daily during 30 days after the procedure) compared to the standardized treatment combining lysine acetylsalicylate (75 mg before and 75 mg daily after the procedure) and clopidogrel (300mg loading dose before and 75 mg daily after the procedure). Patients will be followed during one month. Then they will be all placed under the usual antiplatelet treatment (clopidogrel and lysine acetylsalicylate for two additional months and then lysine acetylsalicylate alone lifelong).
- Conditions
- Aortic Valve Stenosis
- Being tested
- Ticagrelor alone, Combination lysine acetylsalicylate - clopidogrel
- Keywords
- TAVI, Antiplatelet agent, Ticagrelor, Cerebrovascular events
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor aloneDrug
180 mg loading dose before intervention and 90 mg twice daily during 30 days after the procedure
Combination lysine acetylsalicylate - clopidogrelDrug
75 mg before and 75 mg daily after the procedure of lysine acetylsalicylate and 300mg loading dose before and 75 mg of clopidogrel daily after the procedure
| Study group | Role | What they receive |
|---|---|---|
| Standard group | Active comparator | 154 patients Receives: Drug: Combination lysine acetylsalicylate - clopidogrel |
| Ticagrelor group | Experimental | 154 patients Receives: Drug: Ticagrelor alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient presenting at least one event of the Valve Academic Research Consortium-2 (VARC2) composite endpoint
VARC2 composite endpoint :
- All-cause mortality
- All stroke (disabling and non-disabling)
- Life-threatening or disabling bleeding
- Acute kidney injury - Stage 2 or 3 (including renal replacement therapy)
- Coronary artery obstruction requiring intervention
- Major vascular complication
- Valve-related dysfunction requiring repeat procedure
Measured: Day 30
Number of patient died
Measured: Day 30
Number of patient presenting stroke or Transient Ischemic Attack (TIA)
Diagnostic criteria: Acute episode of a focal or global neurological deficit with at least one of the following: change in the level of consciousness, hemiplegia, hemiparesis, numbness, or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax, or other neurological signs or symptoms consistent with stroke Stroke: duration of a focal or global neurological deficit >24 h; OR <24 h if available neuroimaging documents a new haemorrhage or infarct; OR the neurological deficit results in death TIA: duration of a focal or global neurological deficit <24 h, any variable neuroimaging does not demonstrate a new hemorrhage or infarct
Measured: Day 30
Number of patient presenting life-threatening bleeding
Life-threatening bleeding:
Fatal bleeding OR Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome OR Bleeding causing hypovolaemic shock or severe hypotension requiring vasopressors or surgery OR Overt source of bleeding with drop in haemoglobin >5 g/dL or whole blood or packed red blood cells (RBCs) transfusion >4 units
Measured: Day 30
Number of patients presenting post-TAVI acute kidney failure stage 2 or 3 as assessed by VARC2
Measured: Day 30
Number of patients presenting angiographic or echographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the valve prosthesis itself, the native leaflets, calcifications, or dissection
Measured: Day 30
Number of patients presenting major vascular complications
Measured: Day 30
Number of patients requiring a new procedure like Balloon Aortic valvuloplasty (BAV), new procedure of TAVI or Surgical aortic valve replacement (SAVR)
Measured: Day 30
Secondary outcomes (12)
Number of patients presenting at least one conduction disturbance or arrhythmias
Measured: Day 30
Number of patients presenting at least one other TAVI related complication
Measured: Day 30
Number of patients presenting at least one bleeding event (life-threatening, major or minor)
Measured: Day 30
Number of patients with good biological efficiency of the antiplatelet therapy assessed by VerifyNow (VN)
Measured: Day 30
Number of patients with new cerebral event assessed by brain Magnetic Resonance Imaging (MRI)
Measured: Day 5
Number of high-intensity transient signals (HITS) assessed by transcranial Doppler
Measured: Day 1
Assessment of neurological status by the score of Mini Mental State Examination (MMSE)
Measured: At baseline and day 30
Assessment of neurological status by the Dubois's 5 words test
Measured: At baseline and day 30
Assessment of neurological status by the Geriatric Depression Scale (GDS)
Measured: At baseline and day 30
Assessment of neurological status by the basic Activities of Daily Living (ADL) questionnaire
Measured: At baseline and day 30
Assessment of neurological status by the Instrumental Activities of Daily Life (IADL) questionnaire
Measured: At baseline and day 30
Assessment of neurological status by the Short Form Health Survey (SF-12) questionnaire
Measured: At baseline and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start9 May 2016
- Primary completion30 May 2018
- Study completion30 May 2018
Why it stopped: target number of subjects not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lionel LEROUX, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817789
- Sponsor's protocol ID
- CHUBX 2014/24
- Other IDs
- 2015-004144-20, 2015
- Acronym
- TICTAVI
- Status last verified
- Feb 2022
- First submitted
- 29 Apr 2016
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Profile Evaluation of TICagrelor Alone Compared to a Combination of Lysine Acetylsalicylate-Clopidogrel in the Context of Transcatheter Aortic Valve Implantation (TAVI)
- ClinicalTrials.gov ID
- NCT02817789
- Acronym / sponsor ID
- TICTAVI / CHUBX 2014/24
- Conditions
- Aortic Valve Stenosis
- Keywords
- TAVI, Antiplatelet agent, Ticagrelor, Cerebrovascular events
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: target number of subjects not reached
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 9 May 2016 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transcatheter Aortic Valve Implantation (TAVI) is now the method of choice to treat aortic stenosis in old and frail patients. Antiplatelet therapy must be associated for the procedure and during few weeks after implantation in the aim to minimize cerebral embolization. But for now, the best antiplatelet regimen has to be determined. In this context, investigators want to evaluate the safety of use of ticagrelor alone versus standardized therapy which involves lysine acetylsalicylate and clopidogrel. In this study, we will randomly compare 154 patients in each group in terms of early safety (30 days) after the procedure.
Detailed description
In spite of the use of the combination of lysine acetylsalicylate and clopidogrel during and after the procedure of TAVI, rates of stroke remains high, between 4 and 10% regarding the studies and registries. None of the therapeutics have regulatory authorisation for this indication. On the other hand, the rates of bleeding events are also high in this old and frail population. That is why, considering its pharmacological specificity, investigators hypothesize that ticagrelor, used alone, could be non-inferior on safety criteria than the combination of lysine acetylsalicylate and clopidogrel. Our study want to evaluate the safety profile of Ticagrelor alone (180 mg loading dose before intervention and 90 mg twice daily during 30 days after the procedure) compared to the standardized treatment combining lysine acetylsalicylate (75 mg before and 75 mg daily after the procedure) and clopidogrel (300mg loading dose before and 75 mg daily after the procedure). Patients will be followed during one month. Then they will be all placed under the usual antiplatelet treatment (clopidogrel and lysine acetylsalicylate for two additional months and then lysine acetylsalicylate alone lifelong).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | Active comparator | Drug: Combination lysine acetylsalicylate - clopidogrel154 patients |
| Ticagrelor group | Experimental | Drug: Ticagrelor alone154 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ticagrelor alone180 mg loading dose before intervention and 90 mg twice daily during 30 days after the procedure | Drug | Ticagrelor group |
| Combination lysine acetylsalicylate - clopidogrel75 mg before and 75 mg daily after the procedure of lysine acetylsalicylate and 300mg loading dose before and 75 mg of clopidogrel daily after the procedure | Drug | Standard group |
Primary outcome
Number of patient presenting at least one event of the Valve Academic Research Consortium-2 (VARC2) composite endpoint
Time frame: Day 30
VARC2 composite endpoint : * All-cause mortality * All stroke (disabling and non-disabling) * Life-threatening or disabling bleeding * Acute kidney injury - Stage 2 or 3 (including renal replacement therapy) * Coronary artery obstruction requiring intervention * Major vascular complication * Valve-related dysfunction requiring repeat procedure
Number of patient died
Time frame: Day 30
Number of patient presenting stroke or Transient Ischemic Attack (TIA)
Time frame: Day 30
Diagnostic criteria: Acute episode of a focal or global neurological deficit with at least one of the following: change in the level of consciousness, hemiplegia, hemiparesis, numbness, or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax, or other neurological signs or symptoms consistent with stroke Stroke: duration of a focal or global neurological deficit >24 h; OR <24 h if available neuroimaging documents a new haemorrhage or infarct; OR the neurological deficit results in death TIA: duration of a focal or global neurological deficit <24 h, any variable neuroimaging does not demonstrate a new hemorrhage or infarct
Number of patient presenting life-threatening bleeding
Time frame: Day 30
Life-threatening bleeding: Fatal bleeding OR Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome OR Bleeding causing hypovolaemic shock or severe hypotension requiring vasopressors or surgery OR Overt source of bleeding with drop in haemoglobin >5 g/dL or whole blood or packed red blood cells (RBCs) transfusion >4 units
Number of patients presenting post-TAVI acute kidney failure stage 2 or 3 as assessed by VARC2
Time frame: Day 30
Number of patients presenting angiographic or echographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the valve prosthesis itself, the native leaflets, calcifications, or dissection
Time frame: Day 30
Number of patients presenting major vascular complications
Time frame: Day 30
Number of patients requiring a new procedure like Balloon Aortic valvuloplasty (BAV), new procedure of TAVI or Surgical aortic valve replacement (SAVR)
Time frame: Day 30
12 secondary outcomes
Number of patients presenting at least one conduction disturbance or arrhythmias
Time frame: Day 30
Number of patients presenting at least one other TAVI related complication
Time frame: Day 30
Number of patients presenting at least one bleeding event (life-threatening, major or minor)
Time frame: Day 30
Number of patients with good biological efficiency of the antiplatelet therapy assessed by VerifyNow (VN)
Time frame: Day 30
Number of patients with new cerebral event assessed by brain Magnetic Resonance Imaging (MRI)
Time frame: Day 5
Number of high-intensity transient signals (HITS) assessed by transcranial Doppler
Time frame: Day 1
Assessment of neurological status by the score of Mini Mental State Examination (MMSE)
Time frame: At baseline and day 30
Assessment of neurological status by the Dubois's 5 words test
Time frame: At baseline and day 30
Assessment of neurological status by the Geriatric Depression Scale (GDS)
Time frame: At baseline and day 30
Assessment of neurological status by the basic Activities of Daily Living (ADL) questionnaire
Time frame: At baseline and day 30
Assessment of neurological status by the Instrumental Activities of Daily Life (IADL) questionnaire
Time frame: At baseline and day 30
Assessment of neurological status by the Short Form Health Survey (SF-12) questionnaire
Time frame: At baseline and day 30
Results and safety
The study was stopped early (reason given: target number of subjects not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lionel LEROUX, Dr principal investigator
University Hospital, Bordeaux
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ticagrelor alone and Combination lysine acetylsalicylate - clopidogrel in people with Aortic Valve Stenosis, run by University Hospital, Bordeaux at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: target number of subjects not reached). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient presenting at least one event of the Valve Academic Research Consortium-2 (VARC2) composite endpoint (time frame: Day 30). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.