Comparing effectiveness and safety of different blood thinners after transcatheter treatment for aortic stenosis

Anti-Coagulation versus AcetylSalicylic Acid after Transcatheter Aortic Valve Implantation (ACASA-TAVI) - ACASA-TAVI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001554-61-NO

Enrollment

360

Registered

2021-06-01

Start date

2021-08-19

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with aortic stenosis undergoing transcatheter aortic valve implantation.

Interventions

Trade Name: acetylsalicylic acid Product Name: Albyl-E Pharmaceutical Form: Tablet Trade Name: apixaban Product Name: Eliquis Pharmaceutical Form: Tablet Trade Name: rivaroxaban Product Name: Xarelt

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with aortic stenosis who are accepted for transcatheter aortic valve implantation by the heart team and are less than 80 years old at the time of the procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 360

Exclusion criteria

Exclusion criteria: - Any clinical indication for either anticoagulation (atrial fibrillation, venous thrombosis) or antiplatelet drug (recent percutaneous coronary intervention, etc) - Any contraindication for either anticoagulation or antiplatelet drugs - Failure to provide signed consent - Unable to start study medication within 72 hours - Overt cognitive impairment

Design outcomes

Primary

Measure	Time frame
Main Objective: To perform a PROBE-design randomized controlled trial to assess the efficacy and safety of oral anticoagulation therapy versus the standard acetylsalicylic acid after transcatheter aortic valve implantation for aortic stenosis.;Secondary Objective: To assess the association between early signs of structural valve degeneration and patient outcome.;Primary end point(s): The research question translates into two co-primary endpoints at 12 months; one efficacy endpoint powered for superiority of anticoagulation, and one safety endpoint powered for non-inferiority. The important clinical translation is into MACE at 5 and 10 years. All trial endpoints will comply with the VARC-3 definitions. Co-primary endpoints at 12 months: Hypo-attenuated leaflet thickening -CT evidence of increased hypo-attenuated leaflet thickness -Intention-to-treat, superiority, at 12 months Cardiovascular events, composite of -VARC-3 bleeding events (type 1, 2, 3 or 4) -Thromboembolic events (myocardial infarction or stroke of any cause) -All-cause mortality -Per-protocol, non-inferiority, at 12 months At 5 and 10 years, major adverse cardiac events (MACE) will be defined as the rate of the composite of: -Cardiac death -Aortic valve re-intervention -Stroke -Myocardial infarction -Heart failure hospitalization, or -Major, life-threatening, or disabling bleeding ;Timepoint(s) of evaluation of this end point: 12 months, 5 years and 10 yeras	—

Measure

Time frame

Main Objective: To perform a PROBE-design randomized controlled trial to assess the efficacy and safety of oral anticoagulation therapy versus the standard acetylsalicylic acid after transcatheter aortic valve implantation for aortic stenosis.;Secondary Objective: To assess the association between early signs of structural valve degeneration and patient outcome.;Primary end point(s): The research question translates into two co-primary endpoints at 12 months; one efficacy endpoint powered for superiority of anticoagulation, and one safety endpoint powered for non-inferiority. The important clinical translation is into MACE at 5 and 10 years. All trial endpoints will comply with the VARC-3 definitions. Co-primary endpoints at 12 months: Hypo-attenuated leaflet thickening -CT evidence of increased hypo-attenuated leaflet thickness -Intention-to-treat, superiority, at 12 months Cardiovascular events, composite of -VARC-3 bleeding events (type 1, 2, 3 or 4) -Thromboembolic events (myocardial infarction or stroke of any cause) -All-cause mortality -Per-protocol, non-inferiority, at 12 months At 5 and 10 years, major adverse cardiac events (MACE) will be defined as the rate of the composite of: -Cardiac death -Aortic valve re-intervention -Stroke -Myocardial infarction -Heart failure hospitalization, or -Major, life-threatening, or disabling bleeding ;Timepoint(s) of evaluation of this end point: 12 months, 5 years and 10 yeras

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Secondary

Measure	Time frame
Secondary end point(s): Key secondary endpoints (hierarchical): - Clinical efficacy, intention-to-treat, superiority, composite of: o Freedom from all-cause mortality o Freedom from all stroke o Freedom from hospitalization for procedure- or valve-related causes o Freedom from KCCQ overall summary score 10 points - Cardiovascular events, intention-to-treat, superiority - Thromboembolic events - Bleeding events - All-cause mortality Secondary safety endpoints: - The number of adverse events - The number of serious adverse events - Life-threatening or disabling bleeding - Major bleeding - Minor bleeding Exploratory secondary endpoints: - CT signs of valve degeneration - Echocardiographic signs of valve degeneration - Non-procedure-related life-threatening or disabling bleeding (VARC-3) - Number of major adverse clinical events, defined as stroke or transient ischemic attack of any cause, myocardial infarction, re-intervention on the aortic valve, death (cardiac, all-cause, non-cardiac) and heart failure hospitalization - Quality of life as assessed by the KCCQ and the EQ5D 5L EuroQoL questionnaires, and HADS - Per-protocol primary efficacy endpoint sensitivity analysis - Intention-to-treat primary safety endpoint sensitivity analysis - Cognitive function as assessed by the Mini-cog - N-terminal pro-B-type natriuretic peptide (change) - Cardiac troponin T (change) - Infective endocarditis At 5 and 10 years, the secondary endpoints will be: - Individual components of MACE - Progression of valve degeneration - Deterioration of NYHA-class ;Timepoint(s) of evaluation of this end point: 12 months, 5 years and 10 years	—

Measure

Time frame

Secondary end point(s): Key secondary endpoints (hierarchical): - Clinical efficacy, intention-to-treat, superiority, composite of: o Freedom from all-cause mortality o Freedom from all stroke o Freedom from hospitalization for procedure- or valve-related causes o Freedom from KCCQ overall summary score 10 points - Cardiovascular events, intention-to-treat, superiority - Thromboembolic events - Bleeding events - All-cause mortality Secondary safety endpoints: - The number of adverse events - The number of serious adverse events - Life-threatening or disabling bleeding - Major bleeding - Minor bleeding Exploratory secondary endpoints: - CT signs of valve degeneration - Echocardiographic signs of valve degeneration - Non-procedure-related life-threatening or disabling bleeding (VARC-3) - Number of major adverse clinical events, defined as stroke or transient ischemic attack of any cause, myocardial infarction, re-intervention on the aortic valve, death (cardiac, all-cause, non-cardiac) and heart failure hospitalization - Quality of life as assessed by the KCCQ and the EQ5D 5L EuroQoL questionnaires, and HADS - Per-protocol primary efficacy endpoint sensitivity analysis - Intention-to-treat primary safety endpoint sensitivity analysis - Cognitive function as assessed by the Mini-cog - N-terminal pro-B-type natriuretic peptide (change) - Cardiac troponin T (change) - Infective endocarditis At 5 and 10 years, the secondary endpoints will be: - Individual components of MACE - Progression of valve degeneration - Deterioration of NYHA-class ;Timepoint(s) of evaluation of this end point: 12 months, 5 years and 10 years

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Countries

Norway

Contacts

Public ContactProfessor Lars Gullestad

University of Oslo

lars.gullestad@medisin.uio.no

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026