Platelet REACtivity According to TICagrelor Dose After Transcatheter AorticValve Implantation

Symptomatic Aortic Stenosis Clinical Trial

— REACTIC-TAVI  

Official title:

REACTIC-TAVI Trial: Platelet REACtivity According to TICagrelor Dose After Transcatheter AorticValve Implantation. A Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04331145
• Other study ID #: REACTIC2019-HAC
• Secondary ID: 2019-004860-23
• Status: Completed
• Phase: Phase 4
• Start date: June 23, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: February 2022
• Source: Fundacin Biomedica Galicia Sur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Symptomatic Aortic Stenosis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Alvaro Cunqueiro	Vigo	Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
Andres Iñiguez Romo

Country where clinical trial is conducted

Spain, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of treatment in suppressing High Platelet Reactivity	Assess the efficacy of ticagrelor 60 mg/12 hours in suppressing High Platelet Reactivity after TAVI. Platelet reactivity will be assessed by VerifyNow P2Y12.	At least 24 hours before the index-TAVI procedure
Primary	Efficacy of treatment in suppressing High Platelet Reactivity	Assess the efficacy of ticagrelor 60 mg/12 hours in suppressing High Platelet Reactivity after TAVI. Platelet reactivity will be assessed by VerifyNow P2Y12.	24 ± 2 hour post TAVI
Primary	Efficacy of treatment in suppressing High Platelet Reactivity	Assess the efficacy of ticagrelor 60 mg/12 hours in suppressing High Platelet Reactivity after TAVI. Platelet reactivity will be assessed by VerifyNow P2Y12.	30 ± 7 days post TAVI
Primary	Efficacy of treatment in suppressing High Platelet Reactivity	Assess the efficacy of ticagrelor 60 mg/12 hours in suppressing High Platelet Reactivity after TAVI. Platelet reactivity will be assessed by VerifyNow P2Y12.	90 ± 7 days post TAVI
Secondary	Security: incidence of hemorrhagic complications	Evaluate the incidence of hemorrhagic complications after TAVI. As safety endpoint we will assess the incidence of investigator-reported clinical events according to VARC-2 criteria (death, myocardial infarction, stroke, TIA, acute renal injury, bleeding, vascular access-site and access-related complications), including BARC bleeding definitions. For safety endpoint, all BARC criteria, included in VARC-2 criteria will be recorded.	1) At least 24 hours before the index-TAVI procedure 2) 3) 4) 5)
Secondary	Security: incidence of hemorrhagic complications	Evaluate the incidence of hemorrhagic complications after TAVI. As safety endpoint we will assess the incidence of investigator-reported clinical events according to VARC-2 criteria (death, myocardial infarction, stroke, TIA, acute renal injury, bleeding, vascular access-site and access-related complications), including BARC bleeding definitions. For safety endpoint, all BARC criteria, included in VARC-2 criteria will be recorded.	24 ± 2 hour post TAVI
Secondary	Security: incidence of hemorrhagic complications	Evaluate the incidence of hemorrhagic complications after TAVI. As safety endpoint we will assess the incidence of investigator-reported clinical events according to VARC-2 criteria (death, myocardial infarction, stroke, TIA, acute renal injury, bleeding, vascular access-site and access-related complications), including BARC bleeding definitions. For safety endpoint, all BARC criteria, included in VARC-2 criteria will be recorded.	30 ± 7 days post TAVI
Secondary	Security: incidence of hemorrhagic complications	Evaluate the incidence of hemorrhagic complications after TAVI. As safety endpoint we will assess the incidence of investigator-reported clinical events according to VARC-2 criteria (death, myocardial infarction, stroke, TIA, acute renal injury, bleeding, vascular access-site and access-related complications), including BARC bleeding definitions. For safety endpoint, all BARC criteria, included in VARC-2 criteria will be recorded.	90 ± 7 days post TAVI
Secondary	Security: incidence of hemorrhagic complications	Evaluate the incidence of hemorrhagic complications after TAVI. As safety endpoint we will assess the incidence of investigator-reported clinical events according to VARC-2 criteria (death, myocardial infarction, stroke, TIA, acute renal injury, bleeding, vascular access-site and access-related complications), including BARC bleeding definitions. For safety endpoint, all BARC criteria, included in VARC-2 criteria will be recorded.	120 ± 7 days post TAVI