Platelet Reactivity After TAVI: A Multicenter Pilot Study (REAC-TAVI)

Hospital de Meixoeiro

Status and phase: Completed; Phase 4

Conditions: Transcatheter Aortic Valve Implantation; Transcatheter Aortic Valve Replacement; Severe Aortic Valve Stenosis

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT02224066

MEIX-VALV-002

REAC TAVI (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 3 patient groups

Ticagrelor

Experimental group

Description:

Patients with high-on-treatment platelet reactivity (PRU ≥ 208)

Treatment:

Drug: Ticagrelor 90 mg twice per day during three months following TAVI

Aspirin/Clopidogrel

Active Comparator group

Description:

Patients with high-on-treatment platelet reactivity (PRU ≥ 208)

Treatment:

Drug: Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI

Registry arm

No Intervention group

Description:

Patients with normal-on-treatment platelet reactivity (PRU \< 208) will continue with Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI.