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

NCT ID: NCT05732701

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2788 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-27
• Study Completion Date: 2028-12-31

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.

Conditions

Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

Algorithm-guided DAPT duration

Group Type: EXPERIMENTAL

Algorithm-guided DAPT duration

Intervention Type: OTHER

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)

Standard

Standard-of-care DAPT duration

Group Type: ACTIVE_COMPARATOR

Standard-of-care DAPT duration

Intervention Type: OTHER

DAPT strategy at the operators´ discretion in accordance with applicable guidelines

Interventions

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)

Intervention Type: OTHER

Standard-of-care DAPT duration

DAPT strategy at the operators´ discretion in accordance with applicable guidelines

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenz Räber, MD, PhD

Role: STUDY_CHAIR

Department of Cardiology, Bern University Hospital, Bern, Switzerland

Miklos Rohla, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Bern University Hospital, Bern, Switzerland

Locations

University Clinical Center of the Republic of Srpska

Banja Luka, , Bosnia and Herzegovina

Site Status: RECRUITING

UOC Cardiologia San Giovanni Addolorata Hospital

Roma, , Italy

Site Status: RECRUITING

Department of Cardiology, Bern University Hospital

Bern, , Switzerland

Site Status: RECRUITING

Countries

Bosnia and Herzegovina; Italy; Switzerland

Central Contacts

Lorenz Räber, MD, PhD

Role: CONTACT

Lorenz.raeber@insel.ch

+41 31 632 09 29

Miklos Rohla, MD, PhD

Role: CONTACT

miklos.rohla@insel.ch

+41 31 632 21 11

Facility Contacts

Bojan Stanetic, MD, PhD

Role: primary

bojan.stanetic@gmail.com

+387 51 342-100

Flavio Biccirè, Dr.

Role: primary

fbiccire@hsangiovanni.roma.it

Other Identifiers

TAILOR-DAPT

Identifier Type: -

Identifier Source: org_study_id