Algoritmbaserad anpassning av terapi med dubbla blodplättar för att förbättra resultaten efter perkutan kranskärlsintervention (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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Lorenz Räber, MD, PhD
- Telefonnummer: +41 31 632 09 29
- E-post: Lorenz.raeber@insel.ch
Studera Kontakt Backup
- Namn: Miklos Rohla, MD, PhD
- Telefonnummer: +41 31 632 21 11
- E-post: miklos.rohla@insel.ch
Studieorter
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-
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Banja Luka, Bosnien och Hercegovina, 78000
- Rekrytering
- University Clinical Center of the Republic of Srpska
-
Kontakt:
- Bojan Stanetic, MD, PhD
- Telefonnummer: +387 51 342-100
- E-post: bojan.stanetic@gmail.com
-
Huvudutredare:
- Bojan Stanetic, MD, PhD
-
-
-
-
-
Roma, Italien, 00184
- Rekrytering
- UOC Cardiologia San Giovanni Addolorata Hospital
-
Kontakt:
- Flavio Biccirè, Dr.
- E-post: fbiccire@hsangiovanni.roma.it
-
-
-
-
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Bern, Schweiz, 3010
- Rekrytering
- Department of Cardiology, Bern University Hospital
-
Huvudutredare:
- Miklos Rohla, MD, PhD
-
-
Canton of Bern
-
Biel/Bienne, Canton of Bern, Schweiz, 2501
- Rekrytering
- Kardiologie Spitalzentrum Biel
-
Kontakt:
- Roberto Galea, Dr. med.
- Telefonnummer: 032 324 48 77
- E-post: roberto.galea@szb-chb.ch
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Intervention
Algorithm-guided DAPT duration |
PRECISE-DAPT score ≥25 / PRECISE-HBR Score ≥23
PRECISE-DAPT score <25 / PRECISE-HBR Score <23:
|
|
Aktiv komparator: Standard
Standard-of-care DAPT duration |
DAPT strategy at the operators´ discretion in accordance with applicable guidelines |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Net adverse clinical events (NACE)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Målkärlrevaskularisering
Tidsram: 1 år
|
1 år
|
|
|
Definitiv stenttrombos
Tidsram: 1 år
|
1 år
|
|
|
Hjärtinfarkt
Tidsram: 1 år
|
1 år
|
|
|
Någon revaskularisering
Tidsram: 1 år
|
1 år
|
|
|
Stroke
Tidsram: 1 år
|
1 år
|
|
|
Mål revaskularisering av lesion
Tidsram: 1 år
|
1 år
|
|
|
Kardiovaskulär död
Tidsram: 1 år
|
1 år
|
|
|
Död av alla orsaker
Tidsram: 1 år
|
1 år
|
|
|
Målkärl myokardinfarkt
Tidsram: 1 år
|
1 år
|
|
|
Revaskularisering av icke-målkärl
Tidsram: 1 år
|
1 år
|
|
|
Övergående ischemisk attack
Tidsram: 1 år
|
1 år
|
|
|
Spontan hjärtinfarkt
Tidsram: 1 år
|
1 år
|
|
|
Major adverse cardiovascular events (MACE)
Tidsram: 1 year
|
Cardiovascular death, spontaneous myocardial infarction, definite stent thrombosis or stroke |
1 year
|
|
Major or clinically relevant non-major bleeding
Tidsram: 1 year
|
Non-access site related Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding |
1 year
|
|
Major bleeding
Tidsram: 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
Tidsram: 1 year
|
1 year
|
|
|
Target lesion failure
Tidsram: 1 year
|
Cardiac death, target-vessel myocardial infarction or target lesion revascularization |
1 year
|
|
Adherence to DAPT
Tidsram: 1 year
|
According to the TAILOR-DAPT modified Non-adherence Academic Research Consortium (NARC) classification |
1 year
|
|
Adherence to DAPT
Tidsram: 1 year
|
According to the traditional classification (Adherent≥80% of the time from randomization to intended DAPT cessation date) |
1 year
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Net adverse clinical events (NACE)
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Studiestol: Lorenz Räber, MD, PhD, Department of Cardiology, Bern University Hospital, Bern, Switzerland
- Huvudutredare: Miklos Rohla, MD, PhD, Department of Cardiology, Bern University Hospital, Bern, Switzerland
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TAILOR-DAPT
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