Trial | NCT02224066  Report issue

Title

Platelet Reactivity After TAVI: A Multicenter Pilot Study
Assessment of Platelet REACtivity After Transcatheter Aortic Valve Implantation

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ticagrelor acetylsalicylic acid clopidogrel ...

  • Study Participants

    65
A high platelet reactivity in patients with severe symptomatic Aortic Stenosis (AS) selected for TAVI (Transcatheter aortic valve implantation) procedure has been demonstrated previously, and the use of double antiaggregation therapy (DAPT) with Clopidogrel and Acetylsalicylic acid (ASA) do not achieve consistent and adequate suppression of platelet reactivity. The purpose of this study is evaluate the efficacy of ticagrelor alone versus DAPT with clopidogrel and aspirin for the suppression of high platelet reactivity following TAVI.
Study Started
Jan 31
2016
Primary Completion
May 31
2017
Study Completion
Aug 31
2018
Last Update
Aug 03
2018

Drug Ticagrelor 90 mg twice per day during three months following TAVI

Drug Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI

Ticagrelor Experimental

Patients with high-on-treatment platelet reactivity (PRU ≥ 208)

Aspirin/Clopidogrel Active Comparator

Patients with high-on-treatment platelet reactivity (PRU ≥ 208)

Registry arm No Intervention

Patients with normal-on-treatment platelet reactivity (PRU < 208) will continue with Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI.

Criteria 

Inclusion Criteria:

For inclusion in the study subjects should fulfill the following criteria:

Provision of informed consent prior to any study specific procedures.
Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial.
Patients with degenerative symptomatic severe AS accepted for TAVI after evaluation of the Heart Team of each center.
Patients who are not participating in any other clinical trial or research study (registries allowed).

Exclusion Criteria:

Subjects should not enter the study if any of the following exclusion criteria are fulfilled:

Recent stroke <14 days prior to TAVI, non-revascularized severe coronary or carotid artery disease (>70% stenosis) or life expectancy < 12 months
Patients under chronic oral anticoagulation
Patients with proven allergy to aspirin, clopidogrel or ticagrelor
Patients that after TAVI cannot undergo a regimen of single or dual antiplatelet therapy for 3 months due to a new post-TAVI medical indication
Known pregnancy or breast-feeding
Concomitant oral or intravenous therapy with potent inhibitors of cytochrome P450 3A (CYP3A) that cannot be suspended during the course of the study. Medications considered as potent inhibitors are: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (or erythromycin but not astromicin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and more than a daily liter of grapefruit juice.
Thrombocytopenia (<50,000 platelets U/L) well documented and clinically relevant.
Patients with documented moderate or severe hepatic insufficiency
Any condition that may put the patient at risk or influence the outcome of the trial
Patients previously randomized in this trial or in another clinical trial with an investigational product or device over the past 30 days.
Patients who cannot attend follow up visits scheduled in the study
No Results Posted