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

NCT05732701 | Recruiting

• 1 other identifier: TAILOR-DAPT
• Study Type: interventional
• Target: 2,788
• Locations: 3 countries
• Sites: 3

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.

Conditions

Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Major adverse cardiovascular events (MACE)

  1 year

• Major or clinically relevant non-major bleeding

  1 year

• Major bleeding

  1 year

• Any Bleeding Academic Research Consortium (BARC) bleeding

  1 year

• All-cause death

  1 year

Other Outcomes (1)

• Net adverse clinical events (NACE)

  24 months

Study Arms (2)

Intervention

EXPERIMENTAL

Algorithm-guided DAPT duration

Other: Algorithm-guided DAPT duration

Standard

ACTIVE COMPARATOR

Standard-of-care DAPT duration

Other: Standard-of-care DAPT duration

Interventions

Algorithm-guided DAPT duration 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)

Intervention

Standard-of-care DAPT duration OTHER

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

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (3)

University Clinical Center of the Republic of Srpska

Banja Luka, 78000, Bosnia and Herzegovina

RECRUITING

UOC Cardiologia San Giovanni Addolorata Hospital

Roma, 00184, Italy

RECRUITING

Department of Cardiology, Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Lorenz Räber, MD, PhD

  Department of Cardiology, Bern University Hospital, Bern, Switzerland

  STUDY CHAIR

• Miklos Rohla, MD, PhD

  Department of Cardiology, Bern University Hospital, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenz Räber, MD, PhD

CONTACT

+41 31 632 09 29; Lorenz.raeber@insel.ch

Miklos Rohla, MD, PhD

CONTACT

+41 31 632 21 11; miklos.rohla@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Single-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: June 27, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1); IT (1); CH (1)