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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03023020
Other study ID # ECRI-009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 4, 2017
Est. completion date April 30, 2021

Study information

Verified date August 2021
Source ECRI bv
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study compares two lengths of medication therapy (a shortened versus a prolonged dual antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the successfully treatment for coronary heart disease with a drug covered stent (metallic tube). This comparison will be done in patients who, compared to the average patient, are more likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are within the current medical recommendations. The aim of this study is to help improve further standard antiplatelet duration guidelines.


Description:

The study objective is to determine in a high bleeding risk patient population undergoing PCI under standardized treatment (within current guidelines and instructions for use and including the bioresorbable polymer coated Ultimaster sirolimus-eluting stent), whether abbreviated DAPT is non-inferior to prolonged DAPT regimen in terms of NACE within 12 months, whether abbreviated DAPT is non-inferior to prolonged DAPT regimen in terms of MACCE within 12 months and whether abbreviated DAPT is superior to prolonged DAPT regimen in terms of MCB within 12 months. There are two treatment strategies: - abbreviated dual anti-platelet therapy: dual antiplatelet therapy is discontinued and a single antiplatelet agent is continued until at least 11 months post randomization (i.e. 12 months post stent implantation). In patients on oral anticoagulants, dual antiplatelet therapy is discontinued and either Aspirin or Clopidogrel is continued until 5 months post randomization (i.e. 6 months post stent implantation). Oral anticoagulation is continued until at least 11 months post randomization (i.e. 12 months post stent implantation) OR - prolonged dual anti-platelet therapy: aspirin is continued for at least 11 months post randomization (i.e. 12 months post stent implantation), the P2Y12 inhibitor being taken at the time of randomization is continued for at least 5 months and up to 11 months post randomization (i.e. 12 months post stent implantation). In patients on oral anticoagulants, aspirin and Clopidogrel are continued for at least 2 months post randomization (i.e. 3 months post stent implantation) and up to 11 months post randomization (i.e. 12 months after stent implantation). Therefore either aspirin or Clopidogrel is continued up to 11 months post randomization (i.e. 12 months post stent implantation) The study design is an investigator-initiated, randomized, multi-center, clinical trial to be conducted in approximately 100 interventional cardiology centers in across the globe excluding USA. The study includes 2 x 2150 patients (i.e. 4300 patients) Randomization will occur at one month after the PCI procedure. The expected duration of participation for each patient is 14 months.


Recruitment information / eligibility

Status Completed
Enrollment 4579
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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. 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, 1. Patient is on a DAPT regimen of aspirin and a P2Y12 inhibitor 2. 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 1. Patient is on the same type of OAC (e.g. Vitamin K antagonist or NOAC) for at least 7 days 2. 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 randomization. - 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 Exclusion Criteria: 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Aspirin
Dosing per current guidelines and local practice
P2Y12 inhibitor
Dosing per current guidelines and local practice

Locations

Country Name City State
Argentina Buenos Aires Research center Buenos Aires
Argentina Interventional Cardiology Sanatorio Buenos Aires
Australia The Prince Charles Hospital Chermside
Australia St Vincents Hospital Melbourne Melbourne
Australia Research Center Perth Perth
Australia Research Center Sydney Sydney
Australia Wollongong Research Center Wollongong
Austria Research Center , 043-02 Wien
Austria Research Center, 043-01 Wien
Bahrain Research Centre Manama Manama
Bangladesh Dhaka Research Center Dhaka
Belgium Research Center Aalst Aalst
Belgium Research Center Bonheiden Bonheiden
Belgium CHU st.Pierre Bruxelles
Belgium Research Centre Charleroi Charleroi
Belgium Research Center Hasselt Hasselt
Belgium Research Centre Liège Liège
Bulgaria MHAT Sveta Karidad Plovdiv Plovdiv
Bulgaria Sofia Resaerch Center, 359-02 Sofia
Bulgaria Sofia Research Center, 359-01 Sofia
Bulgaria Sofia Research Center, 359-03 Sofia
Czechia Research Center Brno Brno
Czechia Research Center Phraha Praha
Denmark Research Center Roskilde Roskilde
Estonia Research Center Tallinn Tallinn
France Research Center Annecy Annecy
France Hospital Prive Saint Martin Caen
France Research Centre Caen Caen
France Research Centre Créteil Créteil
France Research Center Dijon Dijon
France Hopital de la Timone Marseille
France Research Center Massy Massy
France Hospital de Mercy Metz
France Research Center Montauban Montauban
France Research Centre Montpellier Montpellier
France Research Center Nantes Nantes
France CHU Nimes Nîmes
France Research Center Paris, 033-05 Paris
France Research Center Paris, 033-06 Paris
France Research Centre Rouen Rouen
France Research Center Saint-Denis Saint-Denis
Germany Saarland University Homburg
Germany Cardiology Clinic Landshut
Hungary Research Centre Budapest Budapest
Hungary Research Center Szeged Szeged
India Research Center Chennai, 091-01 Chennai
India Research Center Chennai, 091-05 Chennai
India Research Center Coimbatore Coimbatore
India Research Center Surat Surat
Israel Research Center Haifa Haifa
Israel Research Center Jerusalem Jerusalem
Israel Rabin MC Petah tikva
Israel Research Center Safed Safed
Italy Ospedale Lorenzo Bonomo Andria
Italy Azienda Ospedaliera Brotzu Cagliari
Italy Second university of Naples Monaldi Hospital Caserta
Italy Research Center Catania Catania
Italy AOU Policlinico Gaetano Martino Messina
Italy Niguarda Milan
Italy Research Center Milan, 039-01 Milan
Italy Research Center Milan, 039-04 Milan
Italy Research Center Milan, 039-11 Milan
Italy San Donato Hospital Milan
Italy Ospedale Sandro Pertini Roma
Italy Policlinico Casilino Rome
Italy Policlinico Umberto I Rome
Italy Research Center Rozzano Rozzano
Italy Clinic Cardiology Treviglio
Italy Research Center Vimercate Vimercate
Japan Kokura Memorial Hospital Fukuoka
Japan Research Center Gifu Gifu
Japan Ichinomiya Municipal Hospital Ichinomiya
Japan St.Marianna University School of Medicine Kawasaki
Japan Aichi Medical University Hospital Nagakute
Japan Japan Red Cross Nagoya Daiichi Hospital (1st) Nagoya
Japan Japan Red Cross Nagoya Daini Hospital (2nd) Nagoya
Japan Nagoya University Hospital Nagoya
Japan Osaka police Hospital Osaka
Japan St.Luke's International Hospital Tokyo
Japan Research Center Toyoake Toyoake
Korea, Republic of Research Center Seoul Seoul
Netherlands Research Center Den Bosch 's Hertogenbosch
Netherlands Research Centre Arnhem Arnhem
Netherlands Research Center Breda Breda
Netherlands Research Centre Dordrecht Dordrecht
Netherlands Research Centre Eindhoven Eindhoven
Netherlands Research Center Emmen Emmen
Netherlands Research Centre Enschede Enschede
Netherlands Antonius ziekenhuis Nieuwegein
Netherlands Research Center Rotterdam Rotterdam
Netherlands Research Centre Terneuzen Terneuzen
Netherlands Haga Hospital The Hague
North Macedonia Research Center Skopje Skopje
Poland University Hospital Krakow Krakow
Poland Research Center Krakow Kraków
Poland Miedziowe Centrum Zdrowia SA Lubin
Poland Research Center Poznan Poznan
Poland Research Centre Wroclaw Wroclaw
Saudi Arabia Research Center Jeddah Jeddah
Saudi Arabia Research Center Riyadh Riyadh
Serbia Researcg Center Belgrade, 381-02 Belgrade
Serbia Research Center of Serbia, 381-01 Belgrade
Serbia Research Center Sremska Kamenica Sremska Kamenica
Singapore Singapore Research Center Singapore
Singapore Tan Tock Seng Hospital Singapore
Slovenia Ljubljana Research Center Ljubljana
Spain Research Center Alicante Alicante
Spain Research Center Barcelona, 034-07 Barcelona
Spain Research Center Barcelona, 034-09 Barcelona
Spain Universitario Virgen de la Arrixaca El Palmar
Spain Research Center Huelva Huelva
Spain Hospital Universitario Puerta de hierro Madrid
Spain Research Center Madrid, 034-06 Madrid
Spain Research Center Madrid, 034-10 Madrid
Spain Hospital Universitario Valdecilla Santander
Spain Research Center Vigo Vigo
Sweden Research Center Gavle Gävle
Sweden Research Center Orebro Örebro
Switzerland Lindenhofspital Bern
Switzerland Research Centre Bern Bern
Switzerland Research Centre Fribourg Fribourg
Switzerland University Hospital Geneva Geneva
Switzerland Research Centre Liestal Liestal
Switzerland Research Centre Lugano Lugano
Switzerland Research Centre Zürich Zürich
United Kingdom Research Center Blackburn Blackburn
United Kingdom Research Center Bournemouth Bournemouth
United Kingdom Research Centre Brighton Brighton
United Kingdom Bristol Heart Institute Bristol
United Kingdom Altnagelvin Hospital Derry
United Kingdom St George's Hospital London
United Kingdom Manchester Research Center Manchester
United Kingdom Research Center Newcastle Newcastle Upon Tyne
United Kingdom Research Center Stevenage Stevenage
United Kingdom Research Centre Stoke-on-Trent Stoke-on-Trent
United Kingdom Research Centre Wolverhampton Wolverhampton
United Kingdom Research Centre Worcester Worcester
Vietnam Vietnam National Heart Institute Hanoi

Sponsors (5)

Lead Sponsor Collaborator
ECRI bv Cardialysis B.V., European Cardiovascular Research Center, Terumo Medical Corporation, University of Bern

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Bahrain,  Bangladesh,  Belgium,  Bulgaria,  Czechia,  Denmark,  Estonia,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  North Macedonia,  Poland,  Saudi Arabia,  Serbia,  Singapore,  Slovenia,  Spain,  Sweden,  Switzerland,  United Kingdom,  Vietnam, 

References & Publications (3)

Authors/Task Force members, Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. — View Citation

Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC, Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation 2016

Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group . 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 11 months
Primary Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke 11 months
Primary Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events 11 months
Secondary All cause death 14 months
Secondary Death from cardiovascular causes 14 months
Secondary Myocardial infarction 14 months
Secondary Stroke 14 months
Secondary Bleeding events 14 months
Secondary Definite or probable stent thrombosis 14 months
Secondary Any target vessel revascularization 14 months
Secondary Urgent target vessel revascularization 14 months
Secondary Urgent non-target vessel revascularization 14 months
Secondary Clinically indicated non-target vessel revascularization 14 months
Secondary Transfusion rates both in patients with and/or without clinically detected over bleeding 14 months
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