Platelet REACtivity According to TICagrelor Dose After Transcatheter AorticValve Implantation
NCT ID: NCT04331145
Last Updated: 2022-03-02
Study Results
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Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2020-06-23
2022-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Clopidogrel 75 mg
Platelet reactivity will be assessed by VerifyNow P2Y12 assay in ALL enrolled patients after confirmed use of clopidogrel for 4 days prior TAVI. Patients that have not completed a pre-treatment period of 4 days of clopidogrel will receive a loading dose of 300mg, according to the clinical practice, with assessment of platelet reactivity by VerifyNow P2Y12 at the following 6 hours. Based on results of basal VerifyNow P2Y12 assay at least 24 hours before the index-TAVI procedure, patients with:
Normal basal platelet reactivity (PRU \< 160 assessed with VerifyNow P2Y12 assay): Patients will continue with clopidogrel 75 mg/day until TAVI and during the following three months. All patients will be assessed by clinical follow up and platelet reactivity according to the protocol. Prescription of aspirin 100mg/day will be encourage as per guidelines recommendations.
No interventions assigned to this group
Ticagrelor 60 mg
Platelet reactivity will be assessed by VerifyNow P2Y12 assay in ALL enrolled patients after confirmed use of clopidogrel for 4 days prior TAVI. Patients that have not completed a pre-treatment period of 4 days of clopidogrel will receive a loading dose of 300mg, according to the clinical practice, with assessment of platelet reactivity by VerifyNow P2Y12 at the following 6 hours. Based on results of basal VerifyNow P2Y12 assay at least 24 hrs before the index-TAVI procedure, patients with:
High on-treatment platelet reactivity (PRU ≥ 160 assessed with VerifyNow P2Y12 assay): Patients will be switched to receive ticagrelor 60mg twice daily initiating at least 24 hours before TAVI procedure, in order to arrive to the index TAVI procedure with at least two doses of 60 mg, and will continue with Ticagrelor 60mg twice per day during the following three months.
Ticagrelor 60mg
Platelet reactivity will be assessed by VerifyNow P2Y12 assay in ALL enrolled patients after confirmed use of clopidogrel for 4 days prior TAVI. Patients that have not completed a pre-treatment period of 4 days of clopidogrel will receive a loading dose of 300mg, according to the clinical practice, with assessment of platelet reactivity by VerifyNow P2Y12 at the following 6 hours. Based on results of basal VerifyNow P2Y12 assay at least 24 hours before the index-TAVI procedure, patients with:
High on-treatment platelet reactivity (PRU ≥ 160 assessed with VerifyNow P2Y12 assay): Patients will be switched to receive ticagrelor 60mg twice daily initiating at least 24hrs before TAVI procedure, in order to arrive to the index TAVI procedure with at least two doses of 60 mg, and will continue with Ticagrelor 60mg twice per day during the following three months.
Interventions
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Ticagrelor 60mg
Platelet reactivity will be assessed by VerifyNow P2Y12 assay in ALL enrolled patients after confirmed use of clopidogrel for 4 days prior TAVI. Patients that have not completed a pre-treatment period of 4 days of clopidogrel will receive a loading dose of 300mg, according to the clinical practice, with assessment of platelet reactivity by VerifyNow P2Y12 at the following 6 hours. Based on results of basal VerifyNow P2Y12 assay at least 24 hours before the index-TAVI procedure, patients with:
High on-treatment platelet reactivity (PRU ≥ 160 assessed with VerifyNow P2Y12 assay): Patients will be switched to receive ticagrelor 60mg twice daily initiating at least 24hrs before TAVI procedure, in order to arrive to the index TAVI procedure with at least two doses of 60 mg, and will continue with Ticagrelor 60mg twice per day during the following three months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Accepted for transfemoral TAVI by a Heart Team decision
* Evaluation of platelet reactivity assessed by VerifyNow® assay prior TAVI
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Andres Iñiguez Romo
OTHER
Responsible Party
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Andres Iñiguez Romo
MD, phD
Principal Investigators
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Victor A Jimenez Diaz, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Hospital Álvaro Cunqueiro
Locations
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Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Spain
Countries
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References
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Other Identifiers
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2019-004860-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
REACTIC2019-HAC
Identifier Type: -
Identifier Source: org_study_id
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