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Trial record 2 of 2 for:    "NCT02817789"OR"NCT02989558"

Safety Profile Evaluation of TICagrelor Alone Compared to a Combination of Lysine Acetylsalicylate-Clopidogrel in the Context of Transcatheter Aortic Valve Implantation (TAVI) (TICTAVI)

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ClinicalTrials.gov Identifier: NCT02817789
Recruitment Status : Unknown
Verified April 2016 by University Hospital, Bordeaux.
Recruitment status was:  Recruiting
First Posted : June 29, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Drug: Ticagrelor alone Drug: Combination lysine acetylsalicylate - clopidogrel Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : May 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018


Arm Intervention/treatment
Active Comparator: Standard group
154 patients
Drug: Combination lysine acetylsalicylate - clopidogrel
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

Experimental: Ticagrelor group
154 patients
Drug: Ticagrelor alone
180 mg loading dose before intervention and 90 mg twice daily during 30 days after the procedure




Primary Outcome Measures :
  1. 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

  2. Number of patient died [ Time Frame: Day 30 ]
  3. 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

  4. 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


  5. Number of patients presenting post-TAVI acute kidney failure stage 2 or 3 as assessed by VARC2 [ Time Frame: Day 30 ]
  6. 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 ]
  7. Number of patients presenting major vascular complications [ Time Frame: Day 30 ]
  8. 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 ]

Secondary Outcome Measures :
  1. Number of patients presenting at least one conduction disturbance or arrhythmias [ Time Frame: Day 30 ]
  2. Number of patients presenting at least one other TAVI related complication [ Time Frame: Day 30 ]
  3. Number of patients presenting at least one bleeding event (life-threatening, major or minor) [ Time Frame: Day 30 ]
  4. Number of patients with good biological efficiency of the antiplatelet therapy assessed by VerifyNow (VN) [ Time Frame: Day 30 ]
  5. Number of patients with new cerebral event assessed by brain Magnetic Resonance Imaging (MRI) [ Time Frame: Day 5 ]
  6. Number of high-intensity transient signals (HITS) assessed by transcranial Doppler [ Time Frame: Day 1 ]
  7. Assessment of neurological status by the score of Mini Mental State Examination (MMSE) [ Time Frame: At baseline and day 30 ]
  8. Assessment of neurological status by the Dubois's 5 words test [ Time Frame: At baseline and day 30 ]
  9. Assessment of neurological status by the Geriatric Depression Scale (GDS) [ Time Frame: At baseline and day 30 ]
  10. Assessment of neurological status by the basic Activities of Daily Living (ADL) questionnaire [ Time Frame: At baseline and day 30 ]
  11. Assessment of neurological status by the Instrumental Activities of Daily Life (IADL) questionnaire [ Time Frame: At baseline and day 30 ]
  12. Assessment of neurological status by the Short Form Health Survey (SF-12) questionnaire [ Time Frame: At baseline and day 30 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817789


Contacts
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Contact: Lionel LEROUX, Dr lionel.leroux@chu-bordeaux.fr
Contact: Cécile JORE cecile.jore@chu-bordeaux.fr

Locations
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France
CHRU de Lille Not yet recruiting
Lille, France, 59037
Contact: Eric VANBELLE, Pr       eric.vanbelle2@chru-lille.fr   
Contact: Bérénice MARCHANT       berenice.marchant@chru-lille.fr   
Principal Investigator: Eric VANBELLE, Pr         
APHM Recruiting
Marseille, France, 13005
Contact: Thomas CUISSET, Pr       thomas.cuisset@.ap-hm.fr   
Principal Investigator: Thomas CUISSET, Pr         
CHRU de Nîmes Not yet recruiting
Nîmes, France, 30029
Contact: Guillaume CAYLA, Pr       cayla.guillaume@gmail.com   
Contact: Chrystel LEPERCHOIS-JACQUEY       leperchois.jacquey@gmail.com   
Principal Investigator: Guillaume CAYLA, Pr         
APHP Not yet recruiting
Paris, France, 75013
Contact: Jean-Philippe COLLET, Pr       jean-philippe.collet@psl.aphp.fr   
Contact: Benjamin BERTIN       benjamin.bertin-ext@aphp.fr   
Principal Investigator: Jean-Philippe COLLET, Pr         
CHU de Bordeaux Not yet recruiting
Pessac, France, 33604
Contact: Lionel LEROUX, Dr       lionel.leroux@chu-bordeaux.fr   
Contact: Cécile JORE       cecile.jore@chu-bordeaux.fr   
Principal Investigator: Lionel LEROUX, Dr         
Sub-Investigator: Marina DIJOS, Dr         
Sub-Investigator: Stéphane LAFITTE, Pr         
Sub-Investigator: Frédéric CASASSUS, Dr         
Sub-Investigator: Benjamin SEGUY, Dr         
Sub-Investigator: Julien PELTAN, Dr         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Lionel LEROUX, Dr University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02817789     History of Changes
Other Study ID Numbers: CHUBX 2014/24
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: April 2016

Keywords provided by University Hospital, Bordeaux:
TAVI
Antiplatelet agent
Ticagrelor
Cerebrovascular events

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Clopidogrel
Ticagrelor
Aspirin
Acetylsalicylic acid lysinate
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics