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

University Hospital of Bordeaux

Status and phase

Completed

Phase 3

Conditions

Aortic Valve Stenosis

Treatments

Drug: Ticagrelor alone

Drug: Combination lysine acetylsalicylate - clopidogrel

Study type

Interventional

Funder types

Other

Identifiers

NCT02817789

CHUBX 2014/24

Details and patient eligibility

About

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.

Full 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).

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.