Platelet Reactivity After TAVI: A Multicenter Pilot Study

Phase 4

Completed

• Conditions: Severe Aortic Valve Stenosis; Transcatheter Aortic Valve Implantation; Transcatheter Aortic Valve Replacement
• Interventions: Drug: Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI; Drug: Ticagrelor 90 mg twice per day during three months following TAVI

• Registration Number: NCT02224066
• Lead Sponsor: Hospital de Meixoeiro

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-21
• Study First Posted: 2014-08-25
• Study Start: 2016-01
• Primary Completion: 2017-05
• Status Verified: 2018-08
• Study Completion: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin/Clopidogrel	Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI	Patients with high-on-treatment platelet reactivity (PRU ≥ 208)
Ticagrelor	Ticagrelor 90 mg twice per day during three months following TAVI	Patients with high-on-treatment platelet reactivity (PRU ≥ 208)

Primary Outcome Measures

Name	Time	Method
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).	Three months after antiplatelet treatment initiation following procedure.

Secondary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of ticagrelor compared to clopidogrel and aspirin for the suppression of residual platelet reactivity by VerifyNow P2Y12 assay.	Six hours after antiplatelet treatment initiation following procedure.

Trial Locations

Locations (7)

Hospital Universitario Álvaro Cunqueiro; 🇪🇸 Vigo, Pontevedra, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital Clinic Universitari Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital Santa Creu i Sant Creu; 🇪🇸 Barcelona, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain