Severe Aortic Valve StenosisPhase 4REAC-TAVI2NCT05283356
Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation
A Phase 4 study testing Ticagrelor 60mg in people with Severe Aortic Valve Stenosis and Aortic Valve Stenosis, run by Fundacin Biomedica Galicia Sur at 1 site in Spain.
Trial summary
The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) to prevent valve thrombosis and reduce thromboembolic complications without significantly increasing the risk of bleeding is not yet fully defined and constitutes an important unmet clinical need. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Aortic Valve Stenosis, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR)
- What is being tested?
- Ticagrelor 60mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,206 participants
- Where
- 1 siteSpain
- Study dates
- 21 Jan 2022to 30 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- 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 aortic stenosis (AS) accepted for TAVI with any of the commercial approved TAVI devices after evaluation of the Heart Team of each center,and with at least one of the following comorbidities:
- Diabetes Mellitus, the current WHO diagnostic criteria for diabetes should be maintained - fasting plasma glucose ≥ 7.0mmol/l (126 mg/dl) or 2-h plasma glucose ≥ 11.1mmol/l (200mg/dl), or under treatment with an oral hypoglycemic or insulin.
- Prior coronary artery disease (STEMI, NSTEMI, stable angina, or others) documented by invasive or non-invasive ischemia screening tests or imaging study.
- Prior peripheral arterial disease documented by invasive or non-invasive ischemia screening tests or imaging study.
- Successful TAVI performed by any vascular access.
- Patients who are not participating in any other clinical trial or research study (registries allowed).
Who cannot join
- Patients under chronic oral anticoagulation for any specific pathology.
- Patients that cannot undergo a regimen of single antiplatelet therapy after TAVI.
- History of overt major bleeding or intracranial hemorrhage.
- Active pathological bleeding.
- History of ischemic stroke within the last 30 days prior TAVI.
- Patients with documented severe hepatic insufficiency.
Show all 11Show fewer
- Known pregnancy, breast-feeding, or intend to become pregnant during the study period.
- Concomitant oral or intravenous therapy with potent inhibitors of cytochrome P450 3A (CYP3A) that cannot be suspended during the study.
- Patients randomized 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.
- History of allergic reactions or intolerance to Ticagrelor or Aspirin or any of the excipients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, 36312
Victor A Jiménez Díaz, MD, MPH, +34986825564 ext. 514564, victor.alfonso.jimenez.diaz@sergas.es
Pablo Juan Salvadores, Pharma, MPH, PhD, +34986825564 ext. 514564, pablo.juan.salvadores@sergas.es
About this study
Official title: Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation: Multicenter Randomized Clinical Trial
The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) to prevent valve thrombosis and reduce thromboembolic complications without significantly increasing the risk of bleeding is not yet fully defined and constitutes an important unmet clinical need. Recently, single antiplatelet therapy (SAPT) with Aspirin has been increasingly adopted to avoid bleeding early after TAVI compared with dual antiplatelet therapy. However, TAVI population is affected by a diversity of chronic pathologies that increase the risk of post-TAVI ischemic complications. Stroke is prevalent, especially peri- and early post-TAVI (<1-8% in the 1st year). Although peri-TAVI myocardial infarction (MI) is rare (1-3%), concomitant coronary artery disease (CAD), diabetes mellitus (DM), and peripheral vascular disease (PVD), is very frequent in the TAVI population, affecting around 30-70% of patients. In patients with CAD, the need to re-access the coronary arteries after TAVI is challenging and can be hampered by the trancatheter valve struts.
This is critical in TAVI patients with an acute coronary syndrome and in younger patients with long-life expectancy after TAVI. The use of a P2Y12 inhibitor provides significant ischemic protection in the in the coronary, cerebral and peripheral vascular territories compare to Aspirin. The use of a P2Y12 inhibitor as antiplatelet treatment can decrease the need for new coronary revascularizations and reduce the incidence of thromboembolic complications after TAVI.
- Conditions
- Severe Aortic Valve Stenosis, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Aortic Valve Implantation (TAVI)
- Being tested
- Ticagrelor 60mg
- Keywords
- Severe Aortic Valve Stenosis, Transcatheter aortic valve replacement (TAVR), Transcatheter aortic valve implantation (TAVI), Single antiplatelet therapy (SAPT), Ticagrelor 60 mg, ASA 100 mg, Bleeding, Valve thrombosis
- Medical subject headings
- Aortic Valve Stenosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor 60mgDrug
Ticagrelor 60mg BID after TAVI
| Study group | Role | What they receive |
|---|---|---|
| Acetylsalicylic acid 100mg/day | Active comparator | Aspirin 100 mg/day after TAVI Receives: Drug: Ticagrelor 60mg |
| Ticagrelor 60mg twice per day | Experimental | Ticagrelor 60 mg twice per day after TAVI Receives: Drug: Ticagrelor 60mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of Ticagrelor vs Aspirin in the incidence of NACE at 12 months after TAVI.
NACE is a composite of: all-cause mortality, transient ischemic attack (TIA) or stroke, myocardial infarction, progressive angina leading to emergency evaluation,rehospitalization or new coronary angiography, valve thrombosis, claudication, acute limb ischemia leading to hospitalization, any bleeding.
Measured: 12 months
Secondary outcomes (3)
Efficacy endpoint: Subclinical valve thrombosis
Detected by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion(RLM) at 3 and 12 months after TAVI assessed by 4-dimensional computed tomography (4D-CT) imaging.
HALT: Hypoattenuating thickening in typically meniscal configuration on one or more leaflets, with or without RLM. The extent of HALT should be described per leaflet, using a 4-tier grading scale in regard to leaflet involvement along the curvilinear contour, assuming maximum involvement at the base of the leaflet:
≤25% (limited to the base) >25% and ≤50% >50% and ≤75% >75% Inconclusive for HALT: imaging with insufficient image quality or presence of artifact RLM: The extent of RLM should be described per leaflet, using a 4-tier grading scale None: no reduction in leaflet excursion <50% reduction in leaflet excursion
≥50% reduction in leaflet excursion Immobile: immobile leaflet Inconclusive for RLM: imaging with insufficient image quality or presence of artefact
Measured: 3 and 12 months
Safety endpoint: Major bleeding
Major bleeding (type 2, 3 and 5) at 12 months after TAVI according BARC (Bleeding Academic Research Consortium)
Measured: 12 months
Patient-oriented composite endpoints
Patient-oriented composite endpoints (POCE) at 12 months after TAVI (POCE is a composite of all-cause mortality,TIA/stroke, myocardial infarction, progressive angina leading to emergency evaluation, rehospitalization or new coronary angiography).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start21 Jan 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- 1,206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacin Biomedica Galicia Sur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283356
- Sponsor's protocol ID
- REAC-TAVI 2
- Other IDs
- 2021-003927-13
- Acronym
- REAC-TAVI2
- Status last verified
- Jul 2026
- First submitted
- 1 Mar 2022
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jimenez Diaz VA, Lozano I, Tello Montoliu A, Baz Alonso JA, Iniguez Romo A. Is There a Link Between Stroke, Anticoagulation, and Platelet Reactivity?: The Multifactorial Stroke Mechanism Following TAVR. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2560-2561. doi: 10.1016/j.jcin.2019.10.004. No abstract available.
PubMed 31857029Jimenez Diaz VA, Lozano I, Baz Alonso JA, Calvo Iglesias F, Iniguez Romo A. HALT After TAVR: Searching the Bases, Finding the Cusp. JACC Cardiovasc Interv. 2019 May 13;12(9):894-895. doi: 10.1016/j.jcin.2019.02.011. No abstract available.
PubMed 31072513Jimenez Diaz VA, Tello-Montoliu A, Moreno R, Cruz Gonzalez I, Iniguez Romo A. Reply: The REAC-TAVI Trial: Better Antiplatelet Therapy, Less Haze on the Horizon. JACC Cardiovasc Interv. 2019 Apr 22;12(8):803-804. doi: 10.1016/j.jcin.2019.02.038. No abstract available.
PubMed 31000022Jimenez Diaz VA, Baz Alonso JA, Estevez Ojea O, Serantes Combo A, Rodriguez Paz CM, Iniguez Romo A. Real-Time Detection of an Acute Cerebral Thrombotic Occlusion During a Transcatheter Valve Intervention. JACC Cardiovasc Interv. 2018 Jul 9;11(13):e103-e104. doi: 10.1016/j.jcin.2018.03.048. Epub 2018 Jun 13. No abstract available.
PubMed 29908965Kim WK, Pellegrini C, Ludwig S, Mollmann H, Leuschner F, Makkar R, Leick J, Amat-Santos IJ, Dorr O, Breitbart P, Jimenez Diaz VA, Dabrowski M, Rudolph T, Avanzas P, Kaur J, Toggweiler S, Kerber S, Ranosch P, Regazzoli D, Frank D, Landes U, Webb J, Barbanti M, Purita P, Pilgrim T, Liska B, Tabata N, Rheude T, Seiffert M, Eckel C, Allali A, Valvo R, Yoon SH, Werner N, Nef H, Choi YH, Hamm CW, Sinning JM. Feasibility of Coronary Access in Patients With Acute Coronary Syndrome and Previous TAVR. JACC Cardiovasc Interv. 2021 Jul 26;14(14):1578-1590. doi: 10.1016/j.jcin.2021.05.007.
PubMed 34294400Brouwer J, Nijenhuis VJ, Delewi R, Hermanides RS, Holvoet W, Dubois CLF, Frambach P, De Bruyne B, van Houwelingen GK, Van Der Heyden JAS, Tousek P, van der Kley F, Buysschaert I, Schotborgh CE, Ferdinande B, van der Harst P, Roosen J, Peper J, Thielen FWF, Veenstra L, Chan Pin Yin DRPP, Swaans MJ, Rensing BJWM, van 't Hof AWJ, Timmers L, Kelder JC, Stella PR, Baan J, Ten Berg JM. Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation. N Engl J Med. 2020 Oct 8;383(15):1447-1457. doi: 10.1056/NEJMoa2017815. Epub 2020 Aug 30.
PubMed 32865376Jimenez 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 30621974Trejo-Velasco B, Cruz-Gonzalez I, Tello-Montoliu A, Baz-Alonso JA, Salvadores PJ, Moreno R, Romaguera R, Molina-Navarro E, Paredes-Galan E, De-Miguel-Castro A, Bastos-Fernandez G, Ortiz-Saez A, Fernandez-Barbeira S, Iniguez-Romo A, Jimenez-Diaz VA. Influence of Valve Type and Antiplatelet Regimen on Platelet Reactivity After TAVI: Subanalysis of the REAC-TAVI Trial. J Invasive Cardiol. 2020 Dec;32(12):446-452. doi: 10.25270/jic/20.00167. Epub 2020 Aug 10.
PubMed 32771996Trejo-Velasco B, Tello-Montoliu A, Cruz-Gonzalez I, Moreno R, Baz-Alonso JA, Salvadores PJ, Romaguera R, Molina-Navarro E, Paredes-Galan E, Fernandez-Barbeira S, Ortiz-Saez A, Bastos-Fernandez G, De Miguel-Castro A, Figueiras-Guzman A, Iniguez-Romo A, Jimenez-Diaz VA. Impact of Comorbidities and Antiplatelet Regimen on Platelet Reactivity Levels in Patients Undergoing Transcatheter Aortic Valve Implantation. J Cardiovasc Pharmacol. 2021 Sep 1;78(3):463-473. doi: 10.1097/FJC.0000000000001075.
PubMed 34117181
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation: Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05283356
- Acronym / sponsor ID
- REAC-TAVI2 / REAC-TAVI 2
- Conditions
- Severe Aortic Valve Stenosis, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Aortic Valve Implantation (TAVI)
- Keywords
- Severe Aortic Valve Stenosis, Transcatheter aortic valve replacement (TAVR), Transcatheter aortic valve implantation (TAVI), Single antiplatelet therapy (SAPT), Ticagrelor 60 mg, ASA 100 mg, Bleeding, Valve thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,206 participants (estimated)
- Lead sponsor
- Fundacin Biomedica Galicia SurUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 16 Mar 2022 (actual)
- 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.
The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) to prevent valve thrombosis and reduce thromboembolic complications without significantly increasing the risk of bleeding is not yet fully defined and constitutes an important unmet clinical need. Recently, single antiplatelet therapy (SAPT) with Aspirin has been increasingly adopted to avoid bleeding early after TAVI compared with dual antiplatelet therapy. However, TAVI population is affected by a diversity of chronic pathologies that increase the risk of post-TAVI ischemic complications. Stroke is prevalent, especially peri- and early post-TAVI (<1-8% in the 1st year). Although peri-TAVI myocardial infarction (MI) is rare (1-3%), concomitant coronary artery disease (CAD), diabetes mellitus (DM), and peripheral vascular disease (PVD), is very frequent in the TAVI population, affecting around 30-70% of patients. In patients with CAD, the need to re-access the coronary arteries after TAVI is challenging and can be hampered by the trancatheter valve struts.
This is critical in TAVI patients with an acute coronary syndrome and in younger patients with long-life expectancy after TAVI. The use of a P2Y12 inhibitor provides significant ischemic protection in the in the coronary, cerebral and peripheral vascular territories compare to Aspirin. The use of a P2Y12 inhibitor as antiplatelet treatment can decrease the need for new coronary revascularizations and reduce the incidence of thromboembolic complications after TAVI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetylsalicylic acid 100mg/day | Active comparator | Drug: Ticagrelor 60mgAspirin 100 mg/day after TAVI |
| Ticagrelor 60mg twice per day | Experimental | Drug: Ticagrelor 60mgTicagrelor 60 mg twice per day after TAVI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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 aortic stenosis (AS) accepted for TAVI with any of the commercial approved TAVI devices after evaluation of the Heart Team of each center,and with at least one of the following comorbidities:
- Successful TAVI performed by any vascular access.
- Patients who are not participating in any other clinical trial or research study (registries allowed).
Key exclusion criteria (11 listed)
- Patients under chronic oral anticoagulation for any specific pathology.
- Patients that cannot undergo a regimen of single antiplatelet therapy after TAVI.
- History of overt major bleeding or intracranial hemorrhage.
- Active pathological bleeding.
- History of ischemic stroke within the last 30 days prior TAVI.
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 60mgTicagrelor 60mg BID after TAVI | Drug | Acetylsalicylic acid 100mg/day, Ticagrelor 60mg twice per day |
Primary outcome
Safety and efficacy of Ticagrelor vs Aspirin in the incidence of NACE at 12 months after TAVI.
Time frame: 12 months
NACE is a composite of: all-cause mortality, transient ischemic attack (TIA) or stroke, myocardial infarction, progressive angina leading to emergency evaluation,rehospitalization or new coronary angiography, valve thrombosis, claudication, acute limb ischemia leading to hospitalization, any bleeding.
3 secondary outcomes
Efficacy endpoint: Subclinical valve thrombosis
Time frame: 3 and 12 months
Safety endpoint: Major bleeding
Time frame: 12 months
Patient-oriented composite endpoints
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Background: PubMed 31857029Jimenez Diaz VA, Lozano I, Tello Montoliu A, Baz Alonso JA, Iniguez Romo A. Is There a Link Between Stroke, Anticoagulation, and Platelet Reactivity?: The Multifactorial Stroke Mechanism Following TAVR. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2560-2561. doi: 10.1016/j.jcin.2019.10.004. No abstract available.
- Background: PubMed 31072513Jimenez Diaz VA, Lozano I, Baz Alonso JA, Calvo Iglesias F, Iniguez Romo A. HALT After TAVR: Searching the Bases, Finding the Cusp. JACC Cardiovasc Interv. 2019 May 13;12(9):894-895. doi: 10.1016/j.jcin.2019.02.011. No abstract available.
- Background: PubMed 31000022Jimenez Diaz VA, Tello-Montoliu A, Moreno R, Cruz Gonzalez I, Iniguez Romo A. Reply: The REAC-TAVI Trial: Better Antiplatelet Therapy, Less Haze on the Horizon. JACC Cardiovasc Interv. 2019 Apr 22;12(8):803-804. doi: 10.1016/j.jcin.2019.02.038. No abstract available.
- Background: PubMed 29908965Jimenez Diaz VA, Baz Alonso JA, Estevez Ojea O, Serantes Combo A, Rodriguez Paz CM, Iniguez Romo A. Real-Time Detection of an Acute Cerebral Thrombotic Occlusion During a Transcatheter Valve Intervention. JACC Cardiovasc Interv. 2018 Jul 9;11(13):e103-e104. doi: 10.1016/j.jcin.2018.03.048. Epub 2018 Jun 13. No abstract available.
- Background: PubMed 34294400Kim WK, Pellegrini C, Ludwig S, Mollmann H, Leuschner F, Makkar R, Leick J, Amat-Santos IJ, Dorr O, Breitbart P, Jimenez Diaz VA, Dabrowski M, Rudolph T, Avanzas P, Kaur J, Toggweiler S, Kerber S, Ranosch P, Regazzoli D, Frank D, Landes U, Webb J, Barbanti M, Purita P, Pilgrim T, Liska B, Tabata N, Rheude T, Seiffert M, Eckel C, Allali A, Valvo R, Yoon SH, Werner N, Nef H, Choi YH, Hamm CW, Sinning JM. Feasibility of Coronary Access in Patients With Acute Coronary Syndrome and Previous TAVR. JACC Cardiovasc Interv. 2021 Jul 26;14(14):1578-1590. doi: 10.1016/j.jcin.2021.05.007.
- Background: PubMed 32865376Brouwer J, Nijenhuis VJ, Delewi R, Hermanides RS, Holvoet W, Dubois CLF, Frambach P, De Bruyne B, van Houwelingen GK, Van Der Heyden JAS, Tousek P, van der Kley F, Buysschaert I, Schotborgh CE, Ferdinande B, van der Harst P, Roosen J, Peper J, Thielen FWF, Veenstra L, Chan Pin Yin DRPP, Swaans MJ, Rensing BJWM, van 't Hof AWJ, Timmers L, Kelder JC, Stella PR, Baan J, Ten Berg JM. Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation. N Engl J Med. 2020 Oct 8;383(15):1447-1457. doi: 10.1056/NEJMoa2017815. Epub 2020 Aug 30.
- Results publication: 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.
- Results publication: PubMed 32771996Trejo-Velasco B, Cruz-Gonzalez I, Tello-Montoliu A, Baz-Alonso JA, Salvadores PJ, Moreno R, Romaguera R, Molina-Navarro E, Paredes-Galan E, De-Miguel-Castro A, Bastos-Fernandez G, Ortiz-Saez A, Fernandez-Barbeira S, Iniguez-Romo A, Jimenez-Diaz VA. Influence of Valve Type and Antiplatelet Regimen on Platelet Reactivity After TAVI: Subanalysis of the REAC-TAVI Trial. J Invasive Cardiol. 2020 Dec;32(12):446-452. doi: 10.25270/jic/20.00167. Epub 2020 Aug 10.
- Results publication: PubMed 34117181Trejo-Velasco B, Tello-Montoliu A, Cruz-Gonzalez I, Moreno R, Baz-Alonso JA, Salvadores PJ, Romaguera R, Molina-Navarro E, Paredes-Galan E, Fernandez-Barbeira S, Ortiz-Saez A, Bastos-Fernandez G, De Miguel-Castro A, Figueiras-Guzman A, Iniguez-Romo A, Jimenez-Diaz VA. Impact of Comorbidities and Antiplatelet Regimen on Platelet Reactivity Levels in Patients Undergoing Transcatheter Aortic Valve Implantation. J Cardiovasc Pharmacol. 2021 Sep 1;78(3):463-473. doi: 10.1097/FJC.0000000000001075.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor 60mg in people with Severe Aortic Valve Stenosis and Aortic Valve Stenosis, run by Fundacin Biomedica Galicia Sur at 1 site in Spain.
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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor A Jiménez Díaz, MD, MPH (+34986825564, victor.alfonso.jimenez.diaz@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy of Ticagrelor vs Aspirin in the incidence of NACE at 12 months after TAVI. (time frame: 12 months). 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 NCT05283356, which also lists 9 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 28 Jul 2026.