Adaptation basée sur un algorithme de la double thérapie antiplaquettaire pour améliorer les résultats après des interventions coronariennes percutanées (TAILOR-DAPT)
The use of aspirin combined with a P2Y12 inhibitor (dual antiplatelet therapy, DAPT) represents the standard of care for patients undergoing percutaneous coronary intervention (PCI) with stent implantation. The TAILOR-DAPT trial aims to investigate the benefits of a score-based decision-making algorithm to guide DAPT duration compared to a standard-of-care DAPT duration without the use of risk scores in patients undergoing PCI.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Background:
The use of aspirin combined with a P2Y12 inhibitor (dual antiplatelet therapy, DAPT) represents the standard of care for patients undergoing percutaneous coronary intervention (PCI) with stent implantation. European guidelines recommend to implement risk scores to guide the duration of DAPT after stent implantation (class IIb, level of evidence A). However, its adoption rate remains exceedingly low in daily clinical practice in part due to the lack of direct evidence obtained from a randomized controlled trial supporting this strategy.
Aim:
Using a pragmatic study-design, the investigators aim to determine the efficacy and safety of an algorithm-guided strategy for DAPT duration compared to a standard-of-care DAPT without the use of risk scores in patients undergoing PCI with stent implantation.
Methodology:
This investigator-initiated, single-blind, randomized trial will include a total of 2788 patients aged ≥18 years undergoing PCI with stent implantation. Main exclusion criteria are peri-procedural complications potentially affecting DAPT duration. The study will be nested into a well-running registry to minimize study-related costs (pragmatic trial approach). Patients will be randomized to an algorithm-guided DAPT group or a standard-of-care DAPT group in a 1:1 fashion. In the algorithm-guided group, DAPT duration will be determined according to the PRECISE-DAPT score (≥25 or <25) / Precise-HBR score (≥23 or <23), PCI complexity, and clinical presentation (acute or chronic coronary syndromes). In the standard-of-care DAPT group, treatment duration is at the operator's discretion. The primary endpoint is a composite of net adverse clinical events (NACE) defined as all-cause death, spontaneous myocardial infarction, stroke, definite stent thrombosis or Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding at 1 year.
Potential significance:
This will be the first study evaluating the impact of a score-based decision-making algorithm integrating bleeding and ischemic risks for DAPT duration among patients undergoing PCI. The hypothesis is that the proposed simple decision-making algorithm minimizes bleeding risk and maximizes ischemic benefit compared to a standard-of-care DAPT regimen. Prospective data obtained from a pragmatic randomized controlled trial embedded into an on-going, well-managed PCI registry database may further enhance the adoption rate of such a strategy in clinical practice.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Lorenz Räber, MD, PhD
- Numéro de téléphone: +41 31 632 09 29
- E-mail: Lorenz.raeber@insel.ch
Sauvegarde des contacts de l'étude
- Nom: Miklos Rohla, MD, PhD
- Numéro de téléphone: +41 31 632 21 11
- E-mail: miklos.rohla@insel.ch
Lieux d'étude
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Banja Luka, Bosnie Herzégovine, 78000
- Recrutement
- University Clinical Center of the Republic of Srpska
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Contact:
- Bojan Stanetic, MD, PhD
- Numéro de téléphone: +387 51 342-100
- E-mail: bojan.stanetic@gmail.com
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Chercheur principal:
- Bojan Stanetic, MD, PhD
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Roma, Italie, 00184
- Recrutement
- UOC Cardiologia San Giovanni Addolorata Hospital
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Contact:
- Flavio Biccirè, Dr.
- E-mail: fbiccire@hsangiovanni.roma.it
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Bern, Suisse, 3010
- Recrutement
- Department of Cardiology, Bern University Hospital
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Chercheur principal:
- Miklos Rohla, MD, PhD
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Canton of Bern
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Biel/Bienne, Canton of Bern, Suisse, 2501
- Recrutement
- Kardiologie Spitalzentrum Biel
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Contact:
- Roberto Galea, Dr. med.
- Numéro de téléphone: 032 324 48 77
- E-mail: roberto.galea@szb-chb.ch
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- PCI with drug eluting stent (DES) implantation
- Age ≥18 years
- Ability to sign informed consent before any study-specific procedure
Exclusion Criteria:
- Planned staged PCI (Patients can be enrolled after complete coronary revascularization with no remaining lesions intended for treatment. Patients who have or develop an indication for percutaneous valve intervention can undergo treatment 30 days after full coronary revascularization)
- Indication for oral anticoagulation
- Peri-procedural complication which affects DAPT regimen based on the operator's opinion (e.g. untreated flow-limiting angiographic complication, intraprocedural stent thrombosis, persistent vessel occlusion/no-reflow at the end of the procedure, major side-branch occlusion, puncture-site related or other relevant bleeding)
- Treatment for stent thrombosis at qualifying PCI or within 1 year prior to qualifying PCI
- Active bleeding requiring medical attention at qualifying PCI
- The presence of hemodynamic instability (persistent systolic blood pressure below 90mmHg, continuous infusions of catecholamines, clinical signs of hypoperfusion and/or use of percutaneous left ventricular assist devices)
- Life expectancy less than 1 year
- Women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile)
- Planned surgery within the next 3 months
- Contraindication or known allergy against aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, and prasugrel)
- Participation in a drug trial
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention
Algorithm-guided DAPT duration |
PRECISE-DAPT score ≥25 / PRECISE-HBR Score ≥23
PRECISE-DAPT score <25 / PRECISE-HBR Score <23:
|
|
Comparateur actif: Standard
Standard-of-care DAPT duration |
DAPT strategy at the operators´ discretion in accordance with applicable guidelines |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Net adverse clinical events (NACE)
Délai: 1 year
|
All-cause death, spontaneous myocardial infarction, definite stent thrombosis, stroke or non-access site related BARC 2, 3 or 5 bleeding |
1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Revascularisation du vaisseau cible
Délai: 1 an
|
1 an
|
|
|
Thrombose définitive de stent
Délai: 1 an
|
1 an
|
|
|
Infarctus du myocarde
Délai: 1 année
|
1 année
|
|
|
Toute revascularisation
Délai: 1 année
|
1 année
|
|
|
Accident vasculaire cérébral
Délai: 1 année
|
1 année
|
|
|
Revascularisation de la lésion cible
Délai: 1 an
|
1 an
|
|
|
Décès cardiovasculaire
Délai: 1 an
|
1 an
|
|
|
Décès toutes causes
Délai: 1 an
|
1 an
|
|
|
Infarctus du myocarde du vaisseau cible
Délai: 1 an
|
1 an
|
|
|
Revascularisation des vaisseaux non ciblés
Délai: 1 an
|
1 an
|
|
|
Accident ischémique transitoire
Délai: 1 an
|
1 an
|
|
|
Infarctus du myocarde spontané
Délai: 1 an
|
1 an
|
|
|
Major adverse cardiovascular events (MACE)
Délai: 1 year
|
Cardiovascular death, spontaneous myocardial infarction, definite stent thrombosis or stroke |
1 year
|
|
Major or clinically relevant non-major bleeding
Délai: 1 year
|
Non-access site related Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding |
1 year
|
|
Major bleeding
Délai: 1 year
|
Non-access site related Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding |
1 year
|
|
Any non-access site related Bleeding Academic Research Consortium (BARC) bleeding
Délai: 1 year
|
1 year
|
|
|
Target lesion failure
Délai: 1 year
|
Cardiac death, target-vessel myocardial infarction or target lesion revascularization |
1 year
|
|
Adherence to DAPT
Délai: 1 year
|
According to the TAILOR-DAPT modified Non-adherence Academic Research Consortium (NARC) classification |
1 year
|
|
Adherence to DAPT
Délai: 1 year
|
According to the traditional classification (Adherent≥80% of the time from randomization to intended DAPT cessation date) |
1 year
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Net adverse clinical events (NACE)
Délai: 24 months
|
All-cause death, spontaneous myocardial infarction, definite stent thrombosis, stroke or Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding |
24 months
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Lorenz Räber, MD, PhD, Department of Cardiology, Bern University Hospital, Bern, Switzerland
- Chercheur principal: Miklos Rohla, MD, PhD, Department of Cardiology, Bern University Hospital, Bern, Switzerland
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TAILOR-DAPT
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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