Clinical trial NCT05732701: Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
Official title: Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Percutaneous Coronary Intervention
Platelet Aggregation Inhibitors
Coronary Artery Disease
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 2788
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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), 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.

Eligibility criteria: Inclusion Criteria:

1. PCI with drug eluting stent (DES) implantation
2. Age ≥18 years
3. Ability to sign informed consent before any study-specific procedure

Exclusion Criteria:

1. 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)
2. Indication for oral anticoagulation
3. 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)
4. Treatment for stent thrombosis at qualifying PCI or within 1 year prior to qualifying PCI
5. Active bleeding requiring medical attention at qualifying PCI
6. 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)
7. Life expectancy less than 1 year
8. Women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile)
9. Planned surgery within the next 3 months
10. Contraindication or known allergy against aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, and prasugrel)
11. Participation in a drug trial

Primary outcomes:
measure: Net adverse clinical events (NACE)
timeFrame: 1 year
Secondary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: 1 year
measure: Major or clinically relevant non-major bleeding
timeFrame: 1 year
measure: Major bleeding
timeFrame: 1 year
measure: Any Bleeding Academic Research Consortium (BARC) bleeding
timeFrame: 1 year
measure: All-cause death
timeFrame: 1 year
measure: Cardiovascular death
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 1 year
measure: Spontaneous myocardial infarction
timeFrame: 1 year
measure: Target lesion failure
timeFrame: 1 year
measure: Target vessel revascularization
timeFrame: 1 year
measure: Target vessel myocardial infarction
timeFrame: 1 year
measure: Target lesion revascularization
timeFrame: 1 year
measure: Non-target vessel revascularization
timeFrame: 1 year
measure: Any revascularization
timeFrame: 1 year
measure: Definite stent thrombosis
timeFrame: 1 year
measure: Stroke
timeFrame: 1 year
measure: Transient ischemic attack
timeFrame: 1 year
measure: Adherence to DAPT
timeFrame: 1 year
measure: Adherence to DAPT
timeFrame: 1 year
Other outcomes:
measure: Net adverse clinical events (NACE)
timeFrame: 24 months
Locations:
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Center of the Republic of Srpska
city: Bern
country: Switzerland
facility: Department of Cardiology, Bern University Hospital
Study officials:
affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland
name: Lorenz Räber, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland
name: Miklos Rohla, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: