Platelet Reactivity After TAVI: A Multicenter Pilot Study

NCT ID: NCT02224066

Last Updated: 2018-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-08-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ticagrelor

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

Group Type: EXPERIMENTAL

Ticagrelor 90 mg twice per day during three months following TAVI

Intervention Type: DRUG

Aspirin/Clopidogrel

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

Registry arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ticagrelor 90 mg twice per day during three months following TAVI

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Meixoeiro

OTHER_GOV

Sponsor Role: lead

Responsible Party

Andres Iñiguez Romo, MD, PhD

Chief, Cardiology Department, Hospital Alvaro Cunqueiro

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrés Iñiguez Romo, MD;Phd

Role: PRINCIPAL_INVESTIGATOR

Xerencia de Xestión Integrada de Vigo

Victor A Jimenez Diaz, MD; Msc

Role: PRINCIPAL_INVESTIGATOR

Xerencia de Xestión Integrada de Vigo

Pablo Juan Salvadores, Pharma; MPH

Role: STUDY_DIRECTOR

Xerencia xestión integrada de Vigo

Locations

Hospital Clinic Universitari Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Álvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital Santa Creu i Sant Creu

Barcelona, , Spain

Hospital Virgen de las Nieves

Granada, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario Virgen de la Arrixaca

Murcia, , Spain

Hospital Universitario de Salamanca

Salamanca, , Spain

Countries

Spain

References

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Other Identifiers

REAC TAVI

Identifier Type: OTHER

Identifier Source: secondary_id

MEIX-VALV-002

Identifier Type: -

Identifier Source: org_study_id