Clinical trial NCT04331145: Platelet REACtivity According to TICagrelor Dose After Transcatheter AorticValve Implantation
Official title: REACTIC-TAVI Trial: Platelet REACtivity According to TICagrelor Dose After Transcatheter AorticValve Implantation. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Symptomatic Aortic Stenosis
Keywords: Transcatheter aortic valve implantation (TAVI)
Transcatheter aortic valve replacement (TAVR)
Antiplatelet therapy
Ticagrelor
Clopidogrel
Lead sponsor: Fundacin Biomedica Galicia Sur
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The narrowing of the aortic valve, which prevents blood from reaching the entire body correctly is a common disease in our environment. To correct this problem, many patients undergo Transcatheter Aortic Valve Implantation (TAVI) according to standard clinical practice. Patients have to continue with a specific pharmacological treatment (antiplatelet agents) to avoid possible complications during the first months after the procedure. This treatment is not yet well established. Current guidelines recommend dual antiplatelet therapy with Aspirin and Clopidogrel for 3-6 months after TAVI to avoid thromboembolic complications. But the risk of bleeding events with DAPT in this population is not negligible.

This study aims to determine the degree of response to Ticagrelor 60 mg every 12 hours as a single antiplatelet strategy in patients who do not achieve an adequate response with Clopidogrel 75mg every 24 hours. The study will evaluate if patients have an adequate response to Clopidogrel and if not, then patients will start treatment with Ticagrelor 60 mg every 12 hours after TAVI and until completing 3 months of treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with severe symptomatic aortic stenosis
* Accepted for transfemoral TAVI by a Heart Team decision
* Evaluation of platelet reactivity assessed by VerifyNow® assay prior TAVI

Exclusion Criteria:

* Contraindication to TAVI
* TAVI performed by a different access route than transfemoral
* Ned for oral anticoagulation therapy
* History of intracranial hemorrhage
* Ischemic stroke the 14 days before TAVI
* Active pathological bleeding or diathesis
* Moderate to severe hepatic impairment
* Use of strong CYP34A inhibitors or inducers
* Contraindications to DAPT for 3 months
* Contraindication to clopidogrel or ticagrelor
* Platelet count \<50,000
* Pregnancy or breastfeeding

Primary outcomes:
measure: Efficacy of treatment in suppressing High Platelet Reactivity
timeFrame: At least 24 hours before the index-TAVI procedure
measure: Efficacy of treatment in suppressing High Platelet Reactivity
timeFrame: 24 ± 2 hour post TAVI
measure: Efficacy of treatment in suppressing High Platelet Reactivity
timeFrame: 30 ± 7 days post TAVI
measure: Efficacy of treatment in suppressing High Platelet Reactivity
timeFrame: 90 ± 7 days post TAVI
Secondary outcomes:
measure: Security: incidence of hemorrhagic complications
timeFrame: 1) At least 24 hours before the index-TAVI procedure 2) 3) 4) 5)
measure: Security: incidence of hemorrhagic complications
timeFrame: 24 ± 2 hour post TAVI
measure: Security: incidence of hemorrhagic complications
timeFrame: 30 ± 7 days post TAVI
measure: Security: incidence of hemorrhagic complications
timeFrame: 90 ± 7 days post TAVI
measure: Security: incidence of hemorrhagic complications
timeFrame: 120 ± 7 days post TAVI
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
state: Pontevedra
Study officials:
affiliation: Hospital Álvaro Cunqueiro
name: Victor A Jimenez Diaz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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