Percutaneous Coronary InterventionTAILOR-DAPTNCT05732701
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
A study testing Algorithm-guided DAPT duration and Standard-of-care DAPT duration in people with Percutaneous Coronary Intervention and Platelet Aggregation Inhibitors, run by Insel Gruppe AG, University Hospital Bern at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Coronary Artery Disease
- What is being tested?
- Algorithm-guided DAPT duration and Standard-of-care DAPT duration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,788 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 27 Jun 2023to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PCI with drug eluting stent (DES) implantation
- Age ≥18 years
- Ability to sign informed consent before any study-specific procedure
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Switzerland2 sites, 2 recruiting
- Recruiting
Department of Cardiology, Bern University Hospital
Bern, 3010
Miklos Rohla, MD, PhD
- Recruiting
Kardiologie Spitalzentrum Biel
Biel/Bienne, Canton of Bern, 2501
Roberto Galea, Dr. med., 032 324 48 77, roberto.galea@szb-chb.ch
Bosnia and Herzegovina1 site, 1 recruiting
- Recruiting
University Clinical Center of the Republic of Srpska
Banja Luka, 78000
Bojan Stanetic, MD, PhD, +387 51 342-100, bojan.stanetic@gmail.com
Bojan Stanetic, MD, PhD
Italy1 site, 1 recruiting
- Recruiting
UOC Cardiologia San Giovanni Addolorata Hospital
Roma, 00184
Flavio Biccirè, Dr., fbiccire@hsangiovanni.roma.it
About this study
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.
Read the 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) / 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.
- Conditions
- Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Coronary Artery Disease
- Being tested
- Algorithm-guided DAPT duration, Standard-of-care DAPT duration
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algorithm-guided DAPT durationOther
PRECISE-DAPT score ≥25 / PRECISE-HBR Score ≥23
- 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 / PRECISE-HBR Score <23:
- 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-of-care DAPT durationOther
DAPT strategy at the operators´ discretion in accordance with applicable guidelines
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Algorithm-guided DAPT duration Receives: Other: Algorithm-guided DAPT duration |
| Standard | Active comparator | Standard-of-care DAPT duration Receives: Other: Standard-of-care DAPT duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net adverse clinical events (NACE)
All-cause death, spontaneous myocardial infarction, definite stent thrombosis, stroke or non-access site related BARC 2, 3 or 5 bleeding
Measured: 1 year
Secondary outcomes (19)
Major adverse cardiovascular events (MACE)
Cardiovascular death, spontaneous myocardial infarction, definite stent thrombosis or stroke
Measured: 1 year
Major or clinically relevant non-major bleeding
Non-access site related Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding
Measured: 1 year
Major bleeding
Non-access site related Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding
Measured: 1 year
Any non-access site related Bleeding Academic Research Consortium (BARC) bleeding
Measured: 1 year
All-cause death
Measured: 1 year
Cardiovascular death
Measured: 1 year
Myocardial infarction
Measured: 1 year
Spontaneous myocardial infarction
Measured: 1 year
Target lesion failure
Cardiac death, target-vessel myocardial infarction or target lesion revascularization
Measured: 1 year
Target vessel revascularization
Measured: 1 year
Target vessel myocardial infarction
Measured: 1 year
Target lesion revascularization
Measured: 1 year
Non-target vessel revascularization
Measured: 1 year
Any revascularization
Measured: 1 year
Definite stent thrombosis
Measured: 1 year
Stroke
Measured: 1 year
Transient ischemic attack
Measured: 1 year
Adherence to DAPT
According to the TAILOR-DAPT modified Non-adherence Academic Research Consortium (NARC) classification
Measured: 1 year
Adherence to DAPT
According to the traditional classification (Adherent≥80% of the time from randomization to intended DAPT cessation date)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start27 Jun 2023
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,788 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenz Räber, MD, PhD, Study chair, Department of Cardiology, Bern University Hospital, Bern, SwitzerlandMiklos Rohla, MD, PhD, Principal investigator, Department of Cardiology, Bern University Hospital, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732701
- Sponsor's protocol ID
- TAILOR-DAPT
- Acronym
- TAILOR-DAPT
- Status last verified
- Oct 2026
- First submitted
- 8 Feb 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
- ClinicalTrials.gov ID
- NCT05732701
- Acronym / sponsor ID
- TAILOR-DAPT / TAILOR-DAPT
- Conditions
- Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,788 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) / 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Algorithm-guided DAPT durationAlgorithm-guided DAPT duration |
| Standard | Active comparator | Other: Standard-of-care DAPT durationStandard-of-care DAPT duration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PCI with drug eluting stent (DES) implantation
- Age ≥18 years
- Ability to sign informed consent before any study-specific procedure
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algorithm-guided DAPT durationPRECISE-DAPT score ≥25 / PRECISE-HBR Score ≥23 * 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 / PRECISE-HBR Score <23: * 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) | Other | Intervention |
| Standard-of-care DAPT durationDAPT strategy at the operators´ discretion in accordance with applicable guidelines | Other | Standard |
Primary outcome
Net adverse clinical events (NACE)
Time frame: 1 year
All-cause death, spontaneous myocardial infarction, definite stent thrombosis, stroke or non-access site related BARC 2, 3 or 5 bleeding
19 secondary outcomes
Major adverse cardiovascular events (MACE)
Time frame: 1 year
Major or clinically relevant non-major bleeding
Time frame: 1 year
Major bleeding
Time frame: 1 year
Any non-access site related Bleeding Academic Research Consortium (BARC) bleeding
Time frame: 1 year
All-cause death
Time frame: 1 year
Cardiovascular death
Time frame: 1 year
Myocardial infarction
Time frame: 1 year
Spontaneous myocardial infarction
Time frame: 1 year
Target lesion failure
Time frame: 1 year
Target vessel revascularization
Time frame: 1 year
Target vessel myocardial infarction
Time frame: 1 year
Target lesion revascularization
Time frame: 1 year
Non-target vessel revascularization
Time frame: 1 year
Any revascularization
Time frame: 1 year
Definite stent thrombosis
Time frame: 1 year
Stroke
Time frame: 1 year
Transient ischemic attack
Time frame: 1 year
Adherence to DAPT
Time frame: 1 year
Adherence to DAPT
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Percutaneous Coronary Intervention
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RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
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ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
Coronary Artery Disease, De Novo Stenosis Lesion
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Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorenz Räber, MD, PhD study chair
Department of Cardiology, Bern University Hospital, Bern, Switzerland
Miklos Rohla, MD, PhD principal investigator
Department of Cardiology, Bern University Hospital, Bern, Switzerland
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithm-guided DAPT duration and Standard-of-care DAPT duration in people with Percutaneous Coronary Intervention and Platelet Aggregation Inhibitors, run by Insel Gruppe AG, University Hospital Bern at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland, Bosnia and Herzegovina, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenz Räber, MD, PhD (+41 31 632 09 29, Lorenz.raeber@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net adverse clinical events (NACE) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.