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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

Tracking Information
First Submitted Date  ICMJE August 21, 2014
First Posted Date  ICMJE August 25, 2014
Last Update Posted Date August 3, 2018
Actual Study Start Date  ICMJE January 2016
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2016)
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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2014)
Evaluate the effectiveness of ticagrelor compared to clopidogrel and aspirin for the suppression of residual platelet reactivity by VerifyNow P2Y12 assay. [ Time Frame: Three months after antiplatelet treatment initiation following TAVI. ]
Change History Complete list of historical versions of study NCT02224066 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2016)
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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2014)
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 TAVI. ]
Current Other Pre-specified Outcome Measures
 (submitted: February 24, 2016)
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. ]
Original Other Pre-specified Outcome Measures
 (submitted: August 21, 2014)
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 VARC2 criteria, including BARC bleeding definitions. [ Time Frame: Three months after antiplatelet treatment initiation following TAVI. ]
 
Descriptive Information
Brief Title  ICMJE Platelet Reactivity After TAVI: A Multicenter Pilot Study
Official Title  ICMJE Assessment of Platelet REACtivity After Transcatheter Aortic Valve Implantation
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Severe Aortic Valve Stenosis
  • Transcatheter Aortic Valve Implantation
  • Transcatheter Aortic Valve Replacement
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Ticagrelor
    Patients with high-on-treatment platelet reactivity (PRU ≥ 208)
    Intervention: 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)
    Intervention: 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2018)
65
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2014)
60
Actual Study Completion Date  ICMJE August 2018
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02224066
Other Study ID Numbers  ICMJE MEIX-VALV-002
REAC TAVI ( Other Identifier: 201401 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Andres Iñiguez Romo, MD, PhD, Hospital de Meixoeiro
Study Sponsor  ICMJE Hospital de Meixoeiro
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Hospital de Meixoeiro
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP