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Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation (REAC-TAVI2)

Primary Purpose

Severe Aortic Valve Stenosis, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR)

Status

Recruiting

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Ticagrelor 60mg

About this trial

This is an interventional treatment trial for Severe Aortic Valve Stenosis focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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 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:
1. 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.
2. Prior coronary artery disease (STEMI, NSTEMI, stable angina, or others) documented by invasive or non-invasive ischemia screening tests or imaging study.
3. 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).

Exclusion Criteria:

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.
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.

Sites / Locations

Hospital Alvaro CunqueiroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Acetylsalicylic acid 100mg/day

Ticagrelor 60mg twice per day

Arm Description

Aspirin 100 mg/day after TAVI

Ticagrelor 60 mg twice per day after TAVI

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Safety endpoint: Major bleeding

Major bleeding (type 2, 3 and 5) at 12 months after TAVI according BARC (Bleeding Academic Research Consortium)

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).

Full Information

NCT ID

NCT05283356

First Posted

March 1, 2022

Last Updated

March 18, 2022

Sponsor

Fundacin Biomedica Galicia Sur

1. Study Identification

Unique Protocol Identification Number

NCT05283356

Brief Title

Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation

Acronym

REAC-TAVI2

Official Title

Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation: Multicenter Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 21, 2022 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundacin Biomedica Galicia Sur

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1206 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acetylsalicylic acid 100mg/day

Arm Type

Active Comparator

Arm Description

Aspirin 100 mg/day after TAVI

Arm Title

Ticagrelor 60mg twice per day

Arm Type

Experimental

Arm Description

Ticagrelor 60 mg twice per day after TAVI

Intervention Type

Drug

Intervention Name(s)

Ticagrelor 60mg

Intervention Description

Ticagrelor 60mg BID after TAVI

Primary Outcome Measure Information:

Title

Safety and efficacy of Ticagrelor vs Aspirin in the incidence of NACE at 12 months after TAVI.

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Efficacy endpoint: Subclinical valve thrombosis

Description

Time Frame

3 and 12 months

Title

Safety endpoint: Major bleeding

Description

Major bleeding (type 2, 3 and 5) at 12 months after TAVI according BARC (Bleeding Academic Research Consortium)

Time Frame

12 months

Title

Patient-oriented composite endpoints

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion 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 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). Exclusion Criteria: 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Victor A Jiménez Díaz, MD, MPH

Phone

+34986825564

victor.alfonso.jimenez.diaz@sergas.es

First Name & Middle Initial & Last Name or Official Title & Degree

Pablo Juan-Salvadores, Pharma, MPH, PhD

Phone

+34986825564

pablo.juan.salvadores@sergas.es

Facility Information:

Facility Name

Hospital Alvaro Cunqueiro

City

Vigo

State/Province

Pontevedra

ZIP/Postal Code

36312

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Victor A Jiménez Díaz, MD, MPH

Phone

+34986825564

Ext

514564

victor.alfonso.jimenez.diaz@sergas.es

First Name & Middle Initial & Last Name & Degree

Pablo Juan Salvadores, Pharma, MPH, PhD

Phone

+34986825564

Ext

514564

pablo.juan.salvadores@sergas.es

First Name & Middle Initial & Last Name & Degree

Victor A Jiménez Díaz, MD, MPH

First Name & Middle Initial & Last Name & Degree

Andrés Iñiguez Romo, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31857029

Citation

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.

Results Reference

background

PubMed Identifier

31072513

Citation

Jimenez 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.

Results Reference

background

PubMed Identifier

31000022

Citation

Jimenez 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.

Results Reference

background

PubMed Identifier

29908965

Citation

Jimenez 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.

Results Reference

background

PubMed Identifier

34294400

Citation

Kim 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.

Results Reference

background

PubMed Identifier

32865376

Citation

Brouwer 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 Reference

background

PubMed Identifier

30621974

Citation

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.

Results Reference

result

PubMed Identifier

32771996

Citation

Trejo-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. Epub 2020 Aug 10.

Results Reference

result

PubMed Identifier

34117181

Citation

Trejo-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.

Results Reference

result

Learn more about this trial

Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation

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