E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Aortic stenosis for which a transcatheter aortic valve implantation (TAVI) is performed. |
Aortastenose waarvoor een transkatheter aortaklepimplantatie is verricht. |
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E.1.1.1 | Medical condition in easily understood language |
Aortic stenosis for which a transcatheter aortic valve implantation (TAVI) is performed. |
Aortakleplijden waarvoor een transkatheter aortaklepimplantatie is verricht. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1. To investigate the safety and efficacy of omission of clopidogrel during follow-up in patients without an indication for oral anticoagulation (OAC) after TAVI (Cohort A); 2. To investigate the safety and efficacy of omission of clopidogrel during follow-up in patients with an indication for OAC after TAVI (Cohort B);
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1. Het bepalen van de veiligheid en effectiviteit van het omitteren van clopidogrel in patiënten zonder een indicatie voor OAC na TAVI (Cohort A); 2. Het bepalen van de veiligheid en effectiviteit van het omitteren van clopidogrel in patiënten met een indicatie voor OAC na TAVI (Cohort A);
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E.2.2 | Secondary objectives of the trial |
1. To investigate the safety and efficacy of the studied antithrombotic treatment regimens after TAVI compared with the common practiced antithrombotic treatment after surgical aortic valve replacement (SAVR) (Cohort C); 2. Furthermore we obtain to investigate the effect of omission of clopidogrel on cognitive and functional parameters, quality of life and costs. |
1. Het bepalen van de veiligheid en effectiviteit van de bestudeerde antitrombotische behandelingen na TAVI in vergelijk met de reguliere behandeling na chirurgische aortaklepvervanging (SAVR) (Cohort C); 2. Het bepalen van het effect van het omitteren van clopidogrel op cognitieve en functionele parameters, kwaliteit van leven, en kosten. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Patients undergoing surgical aortic valve replacement (Cohort C). Registry cohort; same safety and efficacy endpoints as Cohort A and B. |
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E.3 | Principal inclusion criteria |
Cohort A 1. Heart team agrees on indication and treatment proposal; 2. Patient has provided written informed consent;
Cohort B 1. Heart team agrees on indication and treatment proposal; 2. Need for long-term oral anticoagulation; 3. Patient has provided written informed consent.
Cohort C 1. Heart team agrees on indication and treatment proposal; 2. Patient has provided written informed consent.
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Cohort A 1. Hartteam bereikt consensus over de indicatie en behandelstrategie; 2. Patiënt heeft informed consent getekend.
Cohort B 1. Hartteam bereikt consensus over de indicatie en behandelstrategie; 2. Nood aan lange termijn orale anticoagulantia; 3. Patiënt heeft informed consent getekend.
Cohort C 1. Hartteam bereikt consensus over de indicatie en behandelstrategie; 2. Patiënt heeft informed consent getekend. |
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E.4 | Principal exclusion criteria |
Cohort A 1. Need for long-term oral anticoagulation; 2. Drug-eluting stent implantation within 3 months prior to TAVI procedure; 3. Bare-metal stent implantation within 1 month prior to TAVI procedure; 4. Allergy or intolerance to aspirin or clopidogrel.
Cohort B 1. Drug-eluting stent implantation within 3 months prior to TAVI procedure; 2. Bare-metal stent implantation within 1 month prior to TAVI procedure; 3. Allergy or intolerance to clopidogrel.
Cohort C 1. Patient is younger than 65 years old; 2. Combination surgical procedure.
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Cohort A 1. Nood aan lange termijn orale anticoagulantia; 2. Drug-eluting stent implantatie binnen 3 maanden voorafgaand aan de TAVI procedure; 3. Bare-metal stent implantatie binnen 1 maand voorafgaand aan de TAVI procedure; 4. Allergie of intolerantie voor aspirine of clopidogrel.
Cohort B 1. Drug-eluting stent implantatie binnen 3 maanden voorafgaand aan de TAVI procedure; 2. Bare-metal stent implantatie binnen 1 maand voorafgaand aan de TAVI procedure; 3. Allergie of intolerantie voor clopidogrel.
Cohort C 1. Patient is jonger dan 65 jaar; 2. Combinatie chirurgische behandeling. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary safety outcome is defined as all bleeding. Co-primary safety outcome is defined as all non-procedure related bleeding. |
Primaire veiligheidseindpunt is gedefinieerd als alle bloedingen. Co-primaire veiligheidseindpunt is gedefinieerd als alle non-procedure gerelateerde bloedingen. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary efficacy outcome is a composite of cardiovascular mortality, major bleeding, life threatening/disabling bleeding, all-cause stroke, and myocardial infarction. Co-secondary efficacy outcome is a composite of cardiovascular mortality, non-procedure related bleeding, all-cause stroke, and myocardial infarction. |
Secundaire effectiviteitseindpunt is een composiet van cardiovasculaire mortaliteit, majeure bloeding, levensbedreigende/invaliderende bloeding, cerebrovasculair accident, en myocardinfarct. Co-secundaire effectiviteitseindpunt is een composiet van cardiovasculaire mortaliteit, non-procedure gerlateerde bloeding, cerebrovasculair accident, en myocardinfarct. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |