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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02224066
Other study ID # MEIX-VALV-002
Secondary ID REAC TAVI
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2016
Est. completion date August 2018

Study information

Verified date August 2018
Source Hospital de Meixoeiro
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date August 2018
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

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


Locations

Country Name City State
Spain Hospital Santa Creu i Sant Creu Barcelona
Spain Hospital Virgen de las Nieves Granada
Spain Hospital Clinic Universitari Bellvitge Hospitalet de Llobregat Barcelona
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Virgen de la Arrixaca Murcia
Spain Hospital Universitario de Salamanca Salamanca
Spain Hospital Universitario Álvaro Cunqueiro Vigo Pontevedra

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Meixoeiro

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Husted S, James S, Becker RC, Horrow J, Katus H, Storey RF, Cannon CP, Heras M, Lopes RD, Morais J, Mahaffey KW, Bach RG, Wojdyla D, Wallentin L; PLATO study group. Ticagrelor versus clopidogrel in elderly patients with acute coronary syndromes: a substudy from the prospective randomized PLATelet inhibition and patient Outcomes (PLATO) trial. Circ Cardiovasc Qual Outcomes. 2012 Sep 1;5(5):680-8. — View Citation

Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22. — View Citation

Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, Thourani VH, Babaliaros VC, Webb JG, Herrmann HC, Bavaria JE, Kodali S, Brown DL, Bowers B, Dewey TM, Svensson LG, Tuzcu M, Moses JW, Williams MR, Siegel RJ, Akin JJ, Anderson WN, Pocock S, Smith CR, Leon MB; PARTNER Trial Investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012 May 3;366(18):1696-704. doi: 10.1056/NEJMoa1202277. Epub 2012 Mar 26. Erratum in: N Engl J Med. 2012 Aug 30;367(9):881. — View Citation

Price MJ, Angiolillo DJ, Teirstein PS, Lillie E, Manoukian SV, Berger PB, Tanguay JF, Cannon CP, Topol EJ. Platelet reactivity and cardiovascular outcomes after percutaneous coronary intervention: a time-dependent analysis of the Gauging Responsiveness with a VerifyNow P2Y12 assay: Impact on Thrombosis and Safety (GRAVITAS) trial. Circulation. 2011 Sep 6;124(10):1132-7. doi: 10.1161/CIRCULATIONAHA.111.029165. Epub 2011 Aug 29. — View Citation

Tousek P, Kocka V, Sulzenko J, Bednar F, Linkova H, Widimsky P. Pharmacodynamic effect of clopidogrel in patients undergoing transcatheter aortic valve implantation. Biomed Res Int. 2013;2013:386074. doi: 10.1155/2013/386074. Epub 2013 Jul 15. — View Citation

Ussia GP, Scarabelli M, Mulè M, Barbanti M, Sarkar K, Cammalleri V, Immè S, Aruta P, Pistritto AM, Gulino S, Deste W, Capodanno D, Tamburino C. Dual antiplatelet therapy versus aspirin alone in patients undergoing transcatheter aortic valve implantation. Am J Cardiol. 2011 Dec 15;108(12):1772-6. doi: 10.1016/j.amjcard.2011.07.049. Epub 2011 Sep 10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 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. Three months after antiplatelet treatment initiation following procedure.
Primary 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 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.
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