Safety Profile Evaluation of TICagrelor Alone Compared to a Combination of Lysine Acetylsalicylat… (NCT02817789) | Clinical Trial Compass
TerminatedPhase 3
Safety Profile Evaluation of TICagrelor Alone Compared to a Combination of Lysine Acetylsalicylate-Clopidogrel in the Context of Transcatheter Aortic Valve Implantation (TAVI)
Stopped: target number of subjects not reached
France50 participantsStarted 2016-05-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patient presenting at least one event of the Valve Academic Research Consortium-2 (VARC2) composite endpoint
Timeframe: Day 30
2
Number of patient died
Timeframe: Day 30
3
Number of patient presenting stroke or Transient Ischemic Attack (TIA)
Timeframe: Day 30
4
Number of patient presenting life-threatening bleeding
Timeframe: Day 30
5
Number of patients presenting post-TAVI acute kidney failure stage 2 or 3 as assessed by VARC2
Timeframe: 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
Timeframe: Day 30
7
Number of patients presenting major vascular complications
Number of patients requiring a new procedure like Balloon Aortic valvuloplasty (BAV), new procedure of TAVI or Surgical aortic valve replacement (SAVR)