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Trial record 13 of 509 for:    ASPIRIN AND P2

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

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ClinicalTrials.gov Identifier: NCT02224066
Recruitment Status : Completed
First Posted : August 25, 2014
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Andres Iñiguez Romo, MD, PhD, 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.

Condition or disease Intervention/treatment Phase
Severe Aortic Valve Stenosis Transcatheter Aortic Valve Implantation Transcatheter Aortic Valve Replacement Drug: Ticagrelor 90 mg twice per day during three months following TAVI Drug: Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Platelet REACtivity After Transcatheter Aortic Valve Implantation
Actual Study Start Date : January 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : August 2018


Arm Intervention/treatment
Experimental: Ticagrelor
Patients with high-on-treatment platelet reactivity (PRU ≥ 208)
Drug: Ticagrelor 90 mg twice per day during three months following TAVI
Active Comparator: Aspirin/Clopidogrel
Patients with high-on-treatment platelet reactivity (PRU ≥ 208)
Drug: Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI
No Intervention: 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.



Primary Outcome Measures :
  1. 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). [ Time Frame: Three months after antiplatelet treatment initiation following procedure. ]

Secondary Outcome Measures :
  1. Evaluate the effectiveness of ticagrelor compared to clopidogrel and aspirin for the suppression of residual platelet reactivity by VerifyNow P2Y12 assay. [ Time Frame: Six hours after antiplatelet treatment initiation following procedure. ]

Other Outcome Measures:
  1. Assess the safety of antiplatelet monotherapy with ticagrelor compared to DAPT with aspirin and clopidogrel, with regard to the incidence of investigator-reported clinical events according to predefined criteria, including bleeding definitions. [ Time Frame: Three months after antiplatelet treatment initiation following procedure. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224066


Locations
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Spain
Hospital Clinic Universitari Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Universitario Álvaro Cunqueiro
Vigo, Pontevedra, Spain, 36312
Hospital Santa Creu i Sant Creu
Barcelona, Spain, 08026
Hospital Virgen de las Nieves
Granada, Spain, 18014
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Sponsors and Collaborators
Hospital de Meixoeiro
Investigators
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Principal Investigator: Andrés Iñiguez Romo, MD;Phd Xerencia de Xestión Integrada de Vigo
Principal Investigator: Victor A Jimenez Diaz, MD; Msc Xerencia de Xestión Integrada de Vigo
Study Director: Pablo Juan Salvadores, Pharma; MPH Xerencia xestión integrada de Vigo

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andres Iñiguez Romo, MD, PhD, Chief, Cardiology Department, Hospital Alvaro Cunqueiro, Hospital de Meixoeiro
ClinicalTrials.gov Identifier: NCT02224066     History of Changes
Other Study ID Numbers: MEIX-VALV-002
REAC TAVI ( Other Identifier: 201401 )
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Andres Iñiguez Romo, MD, PhD, Hospital de Meixoeiro:
Aortic stenosis
TAVI
TAVR
Transcatheter aortic valve implantation
Ticagrelor
Antiplatelet reactivity
Additional relevant MeSH terms:
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Aspirin
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Clopidogrel
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents