XIENCE 28 Global Study

NCT03355742 | Completed Results DMC

• 1 other identifier: ABT-CIP-10235
• Study Type: interventional
• Target: 963
• Locations: 13 countries
• Sites: 52

Brief Summary

XIENCE 28 Global Study is a prospective, single arm, multi-center, open label, non-randomized trial to further evaluate the safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System \[EECSS\], XIENCE Alpine EECSS, XIENCE PROX EECSS, XIENCE ProA EECSS or XIENCE Sierra EECSS of coronary drug-eluting stents

Conditions

Bleeding Disorder; Stroke, Ischemic; Stroke Hemorrhagic; Hematological Disease; Thrombocytopenia; Coagulation Disorder; Anemia; Renal Insufficiency; Coronary Artery Disease

Keywords

XIENCE; High bleeding risk (HBR); Dual antiplatelet therapy (DAPT); Coronary Artery Disease; Drug eluting stent (DES)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE), by Propensity Score Quintiles

  Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium \[ARC\]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium \[BARC\] type 2-5)

  From 1 to 6 months

Secondary Outcomes (35)

• Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)

  From 6 to 12 months

• Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)

  From 1 to 12 months

• Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)

  From 1 to 6 months

• Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)

  From 6 to 12 months

• Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)

  From 1 to 12 months

Study Arms (1)

XIENCE

EXPERIMENTAL

XIENCE + Short duration (1 month) of DAPT

Device: XIENCE; Drug: DAPT

Interventions

XIENCE DEVICE

Subjects who received XIENCE family stent systems will be included.

XIENCE

DAPT DRUG

1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Also known as: Dual antiplatelet therapy

XIENCE

Eligibility Criteria

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

You may qualify if:

• Subject is considered at HBR, defined as meeting one or more of the following criteria at the time of registration and in the opinion of the referring physician, the risk of major bleeding with \> 1-month DAPT outweighs the benefit:
• Subjects ≥ 75 years of age.
• Clinical indication for chronic (at least 6 months) or lifelong anticoagulation therapy.
• History of major bleeding which required medical attention within 12 months of the index procedure.
• History of stroke (ischemic or hemorrhagic).
• Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).
• Systemic conditions associated with an increased bleeding risk (e.g. hematological disorders, including a history of or current thrombocytopenia defined as a platelet count \<100,000/mm\^3, or any known coagulation disorder associated with increased bleeding risk).
• Anemia with hemoglobin \< 11g/dl.
• Subject must be at least 18 years of age.
• Subject must provide written informed consent as approved by the Ethics Committee (EC) of the respective clinical site prior to any trial related procedure.
• Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 1 month, if eligible per protocol.
• Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure.
• Up to three target lesions with a maximum of two target lesions per epicardial vessel.
• Note:
• The definition of epicardial vessels means left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX) and right coronary artery (RCA) and their branches. For example, the subject must not have \>2 lesions requiring treatment within both the LAD and a diagonal branch in total.

You may not qualify if:

• Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI).
• Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
• Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 months prior to index procedure.
• Subject has a known left ventricular ejection fraction (LVEF) \<30%.
• Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use.
• Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month following index procedure.
• Subject with a current medical condition with a life expectancy of less than 12 months.
• Subject intends to participate in an investigational drug or device trial within 12 months following the index procedure.
• Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
• Note: Female subjects of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release). It is accepted, in certain cases, to include subjects having a sterilised regular partner or subjects using a double barrier contraceptive method. However, this should be explicitly justified in special circumstances arising from the trial design, product characteristics and/or trial population.
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
• Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
• Target lesion is in a left main location.
• Target lesion is located within an arterial or saphenous vein graft.
• Target lesion is restenotic from a previous stent implantation.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (52)

Kepler Universitätsklinikum GmbH

Linz, UPR AUS, 4021, Austria

Location

Onze-Lieve-Vrouwziekenhuis Campus Aalst

Aalst, Eflndrs, 9300, Belgium

Location

UZ Gent

Ghent, Flemish, 42100, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Jesse Ziekenhuis

Hasselt, Limburg, 3500, Belgium

Location

Beijing AnZhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

The Second Hospital of Jilin University

Changchun, N China, China

Location

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Bad-wur, 79189, Germany

Location

Elisabeth-Krankenhaus Essen GmbH

Essen, N. RHIN, 45138, Germany

Location

UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

Mainz, Rhinela, 55131, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, Saxony, 4289, Germany

Location

Segeberger Kliniken GmbH

Bad Segeberg, Schlesw, 23795, Germany

Location

Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, 12200, Germany

Location

UKE Hamburg (Universitatsklinik Eppendorf)

Hamburg, 20246, Germany

Location

Prince of Wales Hospital

Hong Kong, Hong Ko, Hong Kong

Location

Queen Elizabeth Hospital

Hong Kong, Hong Ko, Hong Kong

Location

The University of Hong Kong (Queen Mary Hospital)

Hong Kong, HONG KO, Hong Kong

Location

Clinica Mediterranea

Napoli, Campani, 80122, Italy

Location

AOU Federico II - Università degli Studi di Napoli

Napoli, Campani, 80138, Italy

Location

Az.Osp. Universitaria di Ferrara

Cona, Emi-rom, 44124, Italy

Location

AOU di Parma

Parma, Emi-rom, 43126, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Umberto I

Rome, Lazio, 00161, Italy

Location

Policlinico Universitario A. Gemelli

Rome, Lazio, 00168, Italy

Location

Centro Cardiologico Monzino

Milan, Lombard, 20138, Italy

Location

Istituto Clinico Humanitas

Rozzano, Lombard, 20089, Italy

Location

Scheperziekenhuis

Emmen, Drenthe, 7824 AA, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Friesld, 8934 AD, Netherlands

Location

Albert Schweitzer Ziekenhuis

Dordrecht, ZUID, 3318 AT, Netherlands

Location

Hospital de Santa Cruz

Carnaxide, Lisbon District, 2799-523, Portugal

Location

Santa Maria Hospital

Lisbon, Lisbon District, 1649-035, Portugal

Location

National Heart Centre Singapore

Singapore, Central, 169609, Singapore

Location

Tan Tock Seng Hospital

Singapore, Central, 308433, Singapore

Location

HCU Virgen de la Victoria

Málaga, Andalu, 29010, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabr, 39008, Spain

Location

Hospital del Mar

Barcelona, Catalon, 08003, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, Catalon, 08036, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, Cstleon, 47005, Spain

Location

Hospital Alvaro Cunqueiro Dept of Interventional Cardiology

Vigo, Pontev, 36312, Spain

Location

Hospital Universitario Doce de Octubre

Madrid, 28041, Spain

Location

Kantonsspital Aarau

Aarau, Basel, 5001, Switzerland

Location

Center Inselspital Bern

Bern, 3010, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6004, Switzerland

Location

Chang Gung Memorial Hospital

Linkou District, Ntaiwan, 333, Taiwan

Location

National Taiwan University Hospital

Taipei, Ntaiwan, 10002, Taiwan

Location

Taipei Veterans General Hospital (VGH)

Taipei, Ntaiwan, 11217, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Staiwan, 83301, Taiwan

Location

Freeman Hospital

Newcastle upon Tyne, NE ENGL, NE7 7DN, United Kingdom

Location

Craigavon Area Hospital

Portadown, Nirelnd, BT63 5QQ, United Kingdom

Location

Southampton University Hospital

Southampton, Soeast, SO16 6YD, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, Sowest, BH7 7DW, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, Sowest, EX2 5DW, United Kingdom

Location

University Hospital of Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

Related Publications (2)

• Valgimigli M, Cao D, Angiolillo DJ, Bangalore S, Bhatt DL, Ge J, Hermiller J, Makkar RR, Neumann FJ, Saito S, Picon H, Toelg R, Maksoud A, Chehab BM, Choi JW, Campo G, De la Torre Hernandez JM, Kunadian V, Sardella G, Thiele H, Varenne O, Vranckx P, Windecker S, Zhou Y, Krucoff MW, Ruster K, Zheng Y, Mehran R; XIENCE 90 and XIENCE 28 Investigators. Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI. J Am Coll Cardiol. 2021 Nov 23;78(21):2060-2072. doi: 10.1016/j.jacc.2021.08.074.

  PMID: 34794687 DERIVED

• Valgimigli M, Cao D, Makkar RR, Bangalore S, Bhatt DL, Angiolillo DJ, Saito S, Ge J, Neumann FJ, Hermiller J, Picon H, Toelg R, Maksoud A, Chehab BM, Wang LJ, Wang J, Mehran R. Design and rationale of the XIENCE short DAPT clinical program: An assessment of the safety of 3-month and 1-month DAPT in patients at high bleeding risk undergoing PCI with an everolimus-eluting stent. Am Heart J. 2021 Jan;231:147-156. doi: 10.1016/j.ahj.2020.09.019. Epub 2020 Oct 6.

  PMID: 33031789 DERIVED

MeSH Terms

Conditions

Hemostatic Disorders; Ischemic Stroke; Hemorrhagic Stroke; Hematologic Diseases; Thrombocytopenia; Anemia; Renal Insufficiency; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Blood Platelet Disorders; Cytopenia; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Siok Hwee Tan, PhD, Principal Clinical Research Scientist
• Organization: Clinical Affairs, Abbott Vascular

siokhwee.tan@abbott.com

+1 408-845-3581

Study Officials

• Marco Valgimigli, MD

  Bern University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: November 28, 2017
• Study Start: February 9, 2018
• Primary Completion: October 24, 2019
• Study Completion: April 30, 2020
• Last Updated: March 4, 2021
• Results First Posted: February 8, 2021

Record last verified: 2021-02

Locations

AU (1); BE (4); CN (2); DE (7); SG (2); TW (4); GB (6); PT (2); IT (8); CH (3); NL (3); ES (7); HK (3)