To compare two medication therapies to prevent thrombus (blood cloth) formation following the successful treatment of a coronary heart disease with expansion of coronary stent (metallic tube) covered with medication (Drug Eluting Stent-DES): a shortened versus a prolonged dual antiplatelet therapy (DAPT, drugs that inhibit bloodplatelets, blood cells involved in the thrombus formation process).

MAnagement of high bleeding risk patients post bioresorbable polymer coated STEnt implantation with an abbReviated versus prolonged DAPT regimen – MASTER DAPT - MASTER DAPT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001834-25-ES

Enrollment

1350

Registered

2017-10-10

Start date

2017-12-14

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High bleeding risk population represents a significant proportion of coronary artery disease (CAD) patients undergoing coronary stent implantation. Decisions regarding the duration of dual antiplatelet therapy (DAPT) after stent implantation are difficult, especially after implantation of newer generation drug eluting stents (DES) due to conflicting results from recent trials. High bleeding risk patients either male or female eligible for percutaneous coronary intervention will be included. Med

Interventions

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Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: After index PCI, patients aged 18 years or more are eligible for inclusion into the study if the following criteria are met: 1) At least one among the High Bleeding Risk (HBR) criteria (as defined below) is met. 2) All lesions are successfully treated with Ultimaster stent in the context of routine clinical care, i.e. post-procedural angiographic diameter stenosis =65 years) yes F.1.3.1 Number of subjects for this age range 1215

Exclusion criteria

Exclusion criteria: Patients are not eligible if any of the following applies 1)Treated with stents other than Ultimaster stent within 6 months prior to index procedure 2)Treated for in-stent restenosis or stent thrombosis at index PCI or within 6 months before 3)Treated with a bioresorbable scaffold at any time prior to index procedure 4)Cannot provide written informed consent 5)Under judicial protection, tutorship or curatorship 6)Unable to understand and follow study-related instructions or unable to comply with study protocol 7)Active bleeding requiring medical attention (BARC=2) on randomization visit 8)Life expectancy less than one year 9)Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor, prasugrel, cobalt chromium or sirolimus 10)Any planned and anticipated PCI 11)Participation in another trial 12)Pregnant or breast feeding women

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective is to compare, within current guidelines and instructions for use, an abbreviated versus a prolonged DAPT duration after bioresorbable polymer coated Ultimaster sirolimus-eluting stent implantation in patients presenting High Bleeding Risk features.;Secondary Objective: Not applicable;Primary end point(s): This study has 3 primary endpoints: 1)Net adverse clinical endpoints (NACE) defined as a composite of all-cause death, myocardial infarction, stroke and bleeding events defined as BARC 3 or 5 2)Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke 3)Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events The main analyses evaluate the occurrence of the primary endpoints between randomization and 11 months thereafter. In secondary analyses, the occurrence of primary endpoints between randomization and 15 months after index PCI is evaluated.;Timepoint(s) of evaluation of this end point: 11 and 15 months after randomization	—

Measure

Time frame

Main Objective: The objective is to compare, within current guidelines and instructions for use, an abbreviated versus a prolonged DAPT duration after bioresorbable polymer coated Ultimaster sirolimus-eluting stent implantation in patients presenting High Bleeding Risk features.;Secondary Objective: Not applicable;Primary end point(s): This study has 3 primary endpoints: 1)Net adverse clinical endpoints (NACE) defined as a composite of all-cause death, myocardial infarction, stroke and bleeding events defined as BARC 3 or 5 2)Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke 3)Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events The main analyses evaluate the occurrence of the primary endpoints between randomization and 11 months thereafter. In secondary analyses, the occurrence of primary endpoints between randomization and 15 months after index PCI is evaluated.;Timepoint(s) of evaluation of this end point: 11 and 15 months after randomization

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Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints of the study are the following: 1)The individual components of each primary endpoint 2)The composite of cardiovascular death, MI, and stroke 3)The composite of cardiovascular death, MI, and urgent revascularization 4)The composite of cardiovascular death, MI, and any unplanned revascularization 5)Death from cardiovascular causes 6)The composite of definite or probable stent thrombosis 7)Myocardial infarction 8)Any target lesion revascularisation 9)Urgent target lesion revascularization 10)Any target vessel revascularization 11)Urgent target vessel revascularization 12)Any non-target vessel revascularization 13)Any urgent non-target vessel revascularization 14)Bleeding events according to the BARC, TIMI and GUSTO classification 15)Transfusion rates both in patients with and/or without clinically detected over bleeding;Timepoint(s) of evaluation of this end point: 11 and 15 months after randomization	—

Measure

Time frame

Secondary end point(s): The secondary endpoints of the study are the following: 1)The individual components of each primary endpoint 2)The composite of cardiovascular death, MI, and stroke 3)The composite of cardiovascular death, MI, and urgent revascularization 4)The composite of cardiovascular death, MI, and any unplanned revascularization 5)Death from cardiovascular causes 6)The composite of definite or probable stent thrombosis 7)Myocardial infarction 8)Any target lesion revascularisation 9)Urgent target lesion revascularization 10)Any target vessel revascularization 11)Urgent target vessel revascularization 12)Any non-target vessel revascularization 13)Any urgent non-target vessel revascularization 14)Bleeding events according to the BARC, TIMI and GUSTO classification 15)Transfusion rates both in patients with and/or without clinically detected over bleeding;Timepoint(s) of evaluation of this end point: 11 and 15 months after randomization

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Countries

Austria, Germany, Italy, Spain, Sweden

Contacts

Public ContactManaging Director

ECRI-9

info@ecri-trials.com0031102062828

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026