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).

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2017-001834-25-AT
• Date of registration: 28/09/2017
• Prospective Registration: Yes
• Primary sponsor: ECRI-9
• Public title: 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).
• Scientific title: MAnagement of high bleeding risk patients post bioresorbable polymer coated STEnt implantation with an abbReviated versus prolonged DAPT regimen – MASTER DAPT - MASTER DAPT
• Date of first enrolment: 07/11/2017
• Target sample size: 4300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001834-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: Abbreviated DAPT regimen; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: Prolonged DAPT regimen; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Colombia, Czech Republic, Denmark, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Macedonia, the former Yugoslav Republic of, Netherlands, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, United Kingdom, Vietnam

Contacts

• Name: Managing Director
• Affiliation: ECRI-9

• Name: Managing Director
• Affiliation: ECRI-9

Key inclusion & exclusion 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 <20% by visual estimation
3) Free from any flow-limiting angiographic complications (i.e. significant untreated dissection or major side-branch occlusion), which require prolonged DAPT duration based on operator’s opinion.
4) All stages of PCI are complete (if any) and no further PCI is planned.
Inclusion criteria at one-month randomization visit
At randomization visit (one month after index PCI), the following criteria must be met:
1) Fulfilment of at least one HBR criterion (as defined below), or on the basis of post-PCI actionable (i.e. requiring medical attention) non-access site related bleeding episode
2) Uneventful 30-day clinical course, i.e. free from spontaneous MI, symptomatic restenosis, stent thrombosis, stroke and any revascularization (coronary and non-coronary) requiring prolonged DAPT
3) If not on OAC,
a.Patient is on a DAPT regimen of aspirin and a P2Y12 inhibitor
b.Patient with one type of P2Y12 inhibitor for at least 7 days (i.e. no switching between oral P2Y12 inhibitors has occurred in the previous 7 days)
4)If on OAC
a.Patient is on the same type of OAC (e.g. Vitamin K antagonist or NOAC) for at least 7 days
b.Patient is on clopidogrel for at least 7 days
Definition of HBR
Post-PCI patients are at HBR if at least one of the following criteria applies:
•Clinical indication for treatment with oral anticoagulants (OAC) for at least 12 months
•Recent (<12 months) non-access site bleeding episode(s), which required medical attention (i.e. actionable bleeding).
•Previous bleeding episode(s) which required hospitalization if the underlying cause has not been definitively treated (i.e. surgical removal of the bleeding source)
•Age equal or greater than 75 years
•Systemic conditions associated with an increased bleeding risk (e.g. haematological disorders, including a history of or current thrombocytopaenia defined as a platelet count <100,000/mm3 (<100 x 109/L), or any known coagulation disorder associated with increased bleeding risk.
•Documented anaemia defined as repeated haemoglobin levels <11 g/dl or transfusion within 4 weeks before inclusion.
•Need for chronic treatment with steroids or non-steroidal anti-inflammatory drugs
•Diagnosed malignancy (other than skin) considered at high bleeding risk including gastro-intestinal, genito-urethral/renal and pulmonary.
•Stroke at any time or TIA in the previous 6 months
•PRECISE DAPT score of 25 or greater

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 430
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3870

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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.
MedDRA version: 20.0 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Pharmaceutical Form: Tablet
INN or Proposed INN: CLOPIDOGREL
CAS Number: 113665-84-2
Current Sponsor code: CLOPIDOGREL
Other descriptive name: CLOPIDOGREL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-

Pharmaceutical Form: Tablet
INN or Proposed INN: TICAGRELOR
CAS Number: 274693-27-5
Current Sponsor code: TICAGRELOR
Other descriptive name: TICAGRELOR
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-

Pharmaceutical Form: Tablet
INN or Proposed INN: ACETYLSALICYLIC ACID
CAS Number: 50-78-2
Current Sponsor code: ACETYLSALICYLIC ACID
Other descriptive name: ASPIRIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Pharmaceutical Form: Tablet
INN or Proposed INN: PRASUGREL
CAS Number: 150322-43-3
Current Sponsor code: PRASUGREL
Other descriptive name: PRASUGREL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 11 months after randomization

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.

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.

Secondary Objective: Not applicable

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 14 months after randomization

Secondary end point(s): The secondary endpoints of the study are the following:
1)The individual components of each composite primary endpoints
2)The composite of cardiovascular death, MI, and stroke
3)The composite of cardiovascular death, MI, and any revascularization
4)Death from cardiovascular causes
5)The composite of definite or probable stent thrombosis
6)Myocardial infarction
7)Any target vessel revascularization
8)Urgent target vessel revascularization
9)Urgent non-target vessel revascularization
10)Clinically indicated non-target vessel revascularization
11)Bleeding events according to the BARC, TIMI and GUSTO classification
12)Transfusion rates both in patients with and/or without clinically detected overt bleeding

Secondary ID(s)

MasterDapt

NCT03023020

Source(s) of Monetary Support

Terumo Europe NV

Ethics review

Status: Approved
Approval date: 27/10/2017
Contact: