Brief Title
Platelet Reactivity After TAVI: A Multicenter Pilot Study
Official Title
Assessment of Platelet REACtivity After Transcatheter Aortic Valve Implantation
Brief Summary
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Evaluate the effectiveness of ticagrelor compared to clopidogrel and aspirin for the suppression of residual platelet reactivity by a system to verify the patient's platelet reactivity (VerifyNow P2Y12 assay).
Secondary Outcome
Evaluate the effectiveness of ticagrelor compared to clopidogrel and aspirin for the suppression of residual platelet reactivity by VerifyNow P2Y12 assay.
Condition
Severe Aortic Valve Stenosis
Intervention
Ticagrelor 90 mg twice per day during three months following TAVI
Study Arms / Comparison Groups
Ticagrelor
Description: Patients with high-on-treatment platelet reactivity (PRU ≥ 208)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
65
Start Date
January 2016
Completion Date
August 2018
Primary Completion Date
May 2017
Eligibility Criteria
Inclusion Criteria:
For inclusion in the study subjects should fulfill the following criteria:
1. Provision of informed consent prior to any study specific procedures.
2. Adult patients (more than 18 years) with ability to understand and accept the
participation in the clinical trial.
3. Patients with degenerative symptomatic severe AS accepted for TAVI after evaluation of
the Heart Team of each center.
4. 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:
1. Recent stroke <14 days prior to TAVI, non-revascularized severe coronary or carotid
artery disease (>70% stenosis) or life expectancy < 12 months
2. Patients under chronic oral anticoagulation
3. Patients with proven allergy to aspirin, clopidogrel or ticagrelor
4. 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
5. Known pregnancy or breast-feeding
6. 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.
7. Thrombocytopenia (<50,000 platelets U/L) well documented and clinically relevant.
8. Patients with documented moderate or severe hepatic insufficiency
9. Any condition that may put the patient at risk or influence the outcome of the trial
10. Patients previously randomized in this trial or in another clinical trial with an
investigational product or device over the past 30 days.
11. Patients who cannot attend follow up visits scheduled in the study
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Andrés Iñiguez Romo, MD;Phd, ,
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT02224066
Organization ID
MEIX-VALV-002
Secondary IDs
REAC TAVI
Responsible Party
Principal Investigator
Study Sponsor
Hospital de Meixoeiro
Study Sponsor
Andrés Iñiguez Romo, MD;Phd, Principal Investigator, Xerencia de Xestión Integrada de Vigo
Verification Date
August 2018