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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

Tracking Information
First Submitted Date  ICMJE April 29, 2016
First Posted Date  ICMJE June 29, 2016
Last Update Posted Date June 30, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Profile Evaluation of TICagrelor Alone Compared to a Combination of Lysine Acetylsalicylate-Clopidogrel in the Context of Transcatheter Aortic Valve Implantation (TAVI)
Official Title  ICMJE Not Provided
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Aortic Valve Stenosis
Intervention  ICMJE
  • Drug: Ticagrelor alone
    180 mg loading dose before intervention and 90 mg twice daily during 30 days after the procedure
  • 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
Study Arms  ICMJE
  • Active Comparator: Standard group
    154 patients
    Intervention: Drug: Combination lysine acetylsalicylate - clopidogrel
  • Experimental: Ticagrelor group
    154 patients
    Intervention: Drug: Ticagrelor alone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 24, 2016)
308
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2018
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02817789
Other Study ID Numbers  ICMJE CHUBX 2014/24
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lionel LEROUX, Dr University Hospital, Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP