Severe Aortic Valve StenosisPhase 4REAC-TAVINCT02224066

Platelet Reactivity After TAVI: A Multicenter Pilot Study

A Phase 4 study testing Ticagrelor 90 mg twice per day during three months following TAVI and Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI in people with Severe Aortic Valve Stenosis and Transcatheter Aortic Valve Implantation, run by Hospital de Meixoeiro at 7 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Severe Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement
What is being tested?: Ticagrelor 90 mg twice per day during three months following TAVI and Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 7 sitesSpain
Study dates: Jan 2016to Aug 2018
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

For inclusion in the study subjects should fulfill the following criteria:
Provision of informed consent prior to any study specific procedures.
Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial.
Patients with degenerative symptomatic severe AS accepted for TAVI after evaluation of the Heart Team of each center.
Patients who are not participating in any other clinical trial or research study (registries allowed).

Who cannot join

Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
Recent stroke <14 days prior to TAVI, non-revascularized severe coronary or carotid artery disease (>70% stenosis) or life expectancy < 12 months
Patients under chronic oral anticoagulation
Patients with proven allergy to aspirin, clopidogrel or ticagrelor
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
Known pregnancy or breast-feeding

Show all 12Show fewer

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.
Thrombocytopenia (<50,000 platelets U/L) well documented and clinically relevant.
Patients with documented moderate or severe hepatic insufficiency
Any condition that may put the patient at risk or influence the outcome of the trial
Patients previously randomized in this trial or in another clinical trial with an investigational product or device over the past 30 days.
Patients who cannot attend follow up visits scheduled in the study

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Spain7 sites

Hospital Santa Creu i Sant Creu
Barcelona, 08026
Hospital Virgen de las Nieves
Granada, 18014
Hospital Clinic Universitari Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Virgen de la Arrixaca
Murcia, 30120
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Universitario Álvaro Cunqueiro
Vigo, Pontevedra, 36312

Other trials in Spain

About this study

Official title: Assessment of Platelet REACtivity After Transcatheter Aortic Valve Implantation

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
Being tested: Ticagrelor 90 mg twice per day during three months following TAVI, Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI
Keywords: Aortic stenosis, TAVI, TAVR, Transcatheter aortic valve implantation, Ticagrelor, Antiplatelet reactivity
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ticagrelor 90 mg twice per day during three months following TAVIDrug
Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVIDrug

Study groups in NCT02224066
Study group	Role	What they receive
Ticagrelor	Experimental	Patients with high-on-treatment platelet reactivity (PRU ≥ 208) Receives: Drug: Ticagrelor 90 mg twice per day during three months following TAVI
Aspirin/Clopidogrel	Active comparator	Patients with high-on-treatment platelet reactivity (PRU ≥ 208) Receives: Drug: Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI
Registry arm	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Three months after antiplatelet treatment initiation following procedure.

Secondary outcomes (1)

Evaluate the effectiveness of ticagrelor compared to clopidogrel and aspirin for the suppression of residual platelet reactivity by VerifyNow P2Y12 assay.
Measured: Six hours after antiplatelet treatment initiation following procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Aug 2018

First posted25 Aug 2014 (estimated)
Study startJan 2016
Primary completionMay 2017
Study completionAug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Severe Aortic Valve StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02224066
Sponsor's protocol ID: MEIX-VALV-002
Other IDs: REAC TAVI
Acronym: REAC-TAVI
Status last verified: Aug 2018
First submitted: 21 Aug 2014
Last updated: 3 Aug 2018
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

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.
PubMed 20961243
Ussia GP, Scarabelli M, Mule M, Barbanti M, Sarkar K, Cammalleri V, Imme 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.
PubMed 21907949
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.
PubMed 22443478
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.
PubMed 23956980
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.
PubMed 21875913
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. doi: 10.1161/CIRCOUTCOMES.111.964395.
PubMed 22991347
Jimenez Diaz VA, Tello-Montoliu A, Moreno R, Cruz Gonzalez I, Baz Alonso JA, Romaguera R, Molina Navarro E, Juan Salvadores P, Paredes Galan E, De Miguel Castro A, Bastos Fernandez G, Ortiz Saez A, Fernandez Barbeira S, Raposeiras Roubin S, Ocampo Miguez J, Serra Penaranda A, Valdes Chavarri M, Cequier Fillat A, Calvo Iglesias F, Iniguez Romo A. Assessment of Platelet REACtivity After Transcatheter Aortic Valve Replacement: The REAC-TAVI Trial. JACC Cardiovasc Interv. 2019 Jan 14;12(1):22-32. doi: 10.1016/j.jcin.2018.10.005.
PubMed 30621974

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Aortic Stenosis, Severe Aortic Stenosis
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
RecruitingObservational study
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Recruiting
Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
Aortic Valve Stenosis and Insufficiency, Coronary Artery Disease(CAD)

All Severe Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Platelet REACtivity After Transcatheter Aortic Valve Implantation
ClinicalTrials.gov ID: NCT02224066
Acronym / sponsor ID: REAC-TAVI / MEIX-VALV-002
Conditions: Severe Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement
Keywords: Aortic stenosis, TAVI, TAVR, Transcatheter aortic valve implantation, Ticagrelor, Antiplatelet reactivity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Hospital de MeixoeiroOther government
Study start: Jan 2016 (actual)
Primary completion: May 2017 (actual)
Study completion: Aug 2018 (actual)
First posted: 25 Aug 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Ticagrelor	Experimental	Drug: Ticagrelor 90 mg twice per day during three months following TAVIPatients with high-on-treatment platelet reactivity (PRU ≥ 208)
Aspirin/Clopidogrel	Active comparator	Drug: Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVIPatients with high-on-treatment platelet reactivity (PRU ≥ 208)
Registry arm	No intervention	–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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Provision of informed consent prior to any study specific procedures.
Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial.
Patients with degenerative symptomatic severe AS accepted for TAVI after evaluation of the Heart Team of each center.
Patients who are not participating in any other clinical trial or research study (registries allowed).

Key exclusion criteria (12 listed)

Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
Recent stroke <14 days prior to TAVI, non-revascularized severe coronary or carotid artery disease (>70% stenosis) or life expectancy < 12 months
Patients under chronic oral anticoagulation
Patients with proven allergy to aspirin, clopidogrel or ticagrelor
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ticagrelor 90 mg twice per day during three months following TAVI	Drug	Ticagrelor
Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI	Drug	Aspirin/Clopidogrel

Primary outcome

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.

1 secondary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
Background: PubMed 20961243Leon 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.
Background: PubMed 21907949Ussia GP, Scarabelli M, Mule M, Barbanti M, Sarkar K, Cammalleri V, Imme 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.
Background: PubMed 22443478Makkar 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.
Background: PubMed 23956980Tousek 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.
Background: PubMed 21875913Price 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.
Background: PubMed 22991347Husted 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. doi: 10.1161/CIRCOUTCOMES.111.964395.
Derived from this study: PubMed 30621974Jimenez Diaz VA, Tello-Montoliu A, Moreno R, Cruz Gonzalez I, Baz Alonso JA, Romaguera R, Molina Navarro E, Juan Salvadores P, Paredes Galan E, De Miguel Castro A, Bastos Fernandez G, Ortiz Saez A, Fernandez Barbeira S, Raposeiras Roubin S, Ocampo Miguez J, Serra Penaranda A, Valdes Chavarri M, Cequier Fillat A, Calvo Iglesias F, Iniguez Romo A. Assessment of Platelet REACtivity After Transcatheter Aortic Valve Replacement: The REAC-TAVI Trial. JACC Cardiovasc Interv. 2019 Jan 14;12(1):22-32. doi: 10.1016/j.jcin.2018.10.005.
Individual participant dataSharing planned: Undecided

Related trials for Severe Aortic Valve Stenosis

Not yet recruitingPhase 4
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Aortic Stenosis, Severe Aortic Stenosis
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
RecruitingObservational study
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Recruiting
Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial
Aortic Valve Stenosis and Insufficiency, Coronary Artery Disease(CAD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrés Iñiguez Romo, MD;Phd principal investigator

Xerencia de Xestión Integrada de Vigo

Victor A Jimenez Diaz, MD; Msc principal investigator

Xerencia de Xestión Integrada de Vigo

Pablo Juan Salvadores, Pharma; MPH study director

Xerencia xestión integrada de Vigo

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02224066, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.