Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions (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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors
• Intervention / Treatment: Other: Standard-of-care DAPT duration; Other: Algorithm-guided DAPT duration

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.

• Study Type: Interventional
• Enrollment (Estimated): 2788
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lorenz Räber, MD, PhD; Phone Number: +41 31 632 09 29; Email: Lorenz.raeber@insel.ch
• Study Contact Backup: Name: Miklos Rohla, MD, PhD; Phone Number: +41 31 632 21 11; Email: miklos.rohla@insel.ch

Study Locations

• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • Recruiting
    • University Clinical Center of the Republic of Srpska
    • Contact: Bojan Stanetic, MD, PhD; Phone Number: +387 51 342-100; Email: bojan.stanetic@gmail.com
    • Principal Investigator: Bojan Stanetić, MD, PhD
• Italy
  • Roma, Italy, 00184
    • Recruiting
    • UOC Cardiologia San Giovanni Addolorata Hospital
    • Contact: Flavio Biccirè, Dr.; Email: fbiccire@hsangiovanni.roma.it
• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Department of Cardiology, Bern University Hospital
    • Principal Investigator: Miklos Rohla, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Algorithm-guided DAPT duration	Other: Algorithm-guided DAPT duration; PRECISE-DAPT score ≥25; Chronic Coronary Syndromes (CCS): Aspirin + clopidogrel for 1 month, followed by clopidogrel monotherapy; Acute Coronary Syndromes (ACS): Aspirin + ticagrelor for 1 month, followed by ticagrelor monotherapy PRECISE-DAPT score <25: Non-complex CCS: Aspirin + clopidogrel for 6 months, followed by clopidogrel monotherapy; Non-complex ACS: Aspirin + potent P2Y12 inhibitor for 6 months, followed by potent P2Y12 inhibitor monotherapy; Complex CCS or ACS: Aspirin + P2Y12 inhibitor for 12 months, followed by P2Y12 inhibitor monotherapy (potent P2Y12 inhibitor mandatory for ACS)
Active Comparator: Standard; Standard-of-care DAPT duration	Other: Standard-of-care DAPT duration; DAPT strategy at the operators´ discretion in accordance with applicable guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net adverse clinical events (NACE)	All-cause death, spontaneous myocardial infarction, definite stent thrombosis, stroke or Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target vessel revascularization		1 year
Definite stent thrombosis		1 year
Myocardial infarction		1 year
Any revascularization		1 year
Stroke		1 year
Target lesion revascularization		1 year
Cardiovascular death		1 year
All-cause death		1 year
Target lesion failure	Cardiac death, target-vessel myocardial infarction or target lesion revascularization	1 year
Target vessel myocardial infarction		1 year
Non-target vessel revascularization		1 year
Transient ischemic attack		1 year
Major or clinically relevant non-major bleeding	Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding	1 year
Major bleeding	Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding	1 year
Any Bleeding Academic Research Consortium (BARC) bleeding		1 year
Adherence to DAPT	According to the TAILOR-DAPT modified Non-adherence Academic Research Consortium (NARC) classification	1 year
Adherence to DAPT	According to the traditional classification (Adherent≥80% of the time from randomization to intended DAPT cessation date)	1 year
Major adverse cardiovascular events (MACE)	Cardiovascular death, spontaneous myocardial infarction, definite stent thrombosis or stroke	1 year
Spontaneous myocardial infarction		1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net adverse clinical events (NACE)	All-cause death, spontaneous myocardial infarction, definite stent thrombosis, stroke or Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding	24 months

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Study Chair: Lorenz Räber, MD, PhD, Department of Cardiology, Bern University Hospital, Bern, Switzerland; Principal Investigator: Miklos Rohla, MD, PhD, Department of Cardiology, Bern University Hospital, Bern, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Oxymetazoline
• Other Study ID Numbers: TAILOR-DAPT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No