XIENCE 28 Global Study

NCT ID: NCT03355742

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 963 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-09
• Study Completion Date: 2020-04-30

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

Detailed Description

The XIENCE 28 Global Study will evaluate the safety of 1-month DAPT following XIENCE implantation in HBR patients. A minimum of 800 to a maximum of 960 subjects will be registered from approximately 50 sites globally and subject registration is capped at 120 per site. Eligibility of P2Y12 receptor inhibitor discontinuation will be assessed at 1-month follow-up. Subjects who are free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis (ARC definite/probable) within 1 month (prior to 1-month visit but at least 28 days) after stenting and have been compliant with 1-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days are considered as "1-month clear", and will discontinue P2Y12 receptor inhibitor as early as 28 days and continue with aspirin monotherapy through 12-month follow-up.

All registered subjects will be followed at 1, 3, 6 and 12 months post index procedure. The data collected from the XIENCE 28 Global Study will be compared with the historical control of non-complex HBR subjects treated with standard DAPT up to 12 months from the XIENCE V USA Study .

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

XIENCE

XIENCE + Short duration (1 month) of DAPT

Group Type: EXPERIMENTAL

XIENCE

Intervention Type: DEVICE

Subjects who received XIENCE family stent systems will be included.

DAPT

Intervention Type: DRUG

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

Interventions

XIENCE

Subjects who received XIENCE family stent systems will be included.

Intervention Type: DEVICE

DAPT

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

Intervention Type: DRUG

Other Intervention Names

Dual antiplatelet therapy

Eligibility Criteria

Inclusion Criteria

1. 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:

1. Subjects ≥ 75 years of age.

2. Clinical indication for chronic (at least 6 months) or lifelong anticoagulation therapy.

3. History of major bleeding which required medical attention within 12 months of the index procedure.

4. History of stroke (ischemic or hemorrhagic).

5. Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).

6. 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).

7. Anemia with hemoglobin < 11g/dl.

2. Subject must be at least 18 years of age.

3. Subject must provide written informed consent as approved by the Ethics Committee (EC) of the respective clinical site prior to any trial related procedure.

4. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 1 month, if eligible per protocol.

5. Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure.

1. Up to three target lesions with a maximum of two target lesions per epicardial vessel.

Note:

1. 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.

2. If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion.

2. Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.

3. Exclusive use of XIENCE family of stent systems during the index procedure.

4. Target lesion has been treated successfully, which is defined as achievement of a final in-stent residual diameter stenosis of <20% with final thrombolysis in myocardial infarction (TIMI-3) flow assessed by online quantitative angiography or visual estimation, with no residual dissection National Heart, Lung, and Blood Institute (NHLBI) grade ≥ type B, and no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting > 5 minutes, and no ST segment elevation > 0.5mm or depression lasting > 5 minutes.

Exclusion Criteria

1. Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI).

2. 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.

3. Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 months prior to index procedure.

4. Subject has a known left ventricular ejection fraction (LVEF) <30%.

5. Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use.

6. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month following index procedure.

7. Subject with a current medical condition with a life expectancy of less than 12 months.

8. Subject intends to participate in an investigational drug or device trial within 12 months following the index procedure.

9. 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.

10. 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.

11. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

1. Target lesion is in a left main location.

2. Target lesion is located within an arterial or saphenous vein graft.

3. Target lesion is restenotic from a previous stent implantation.

4. Target lesion is a chronic total occlusion (CTO, defined as lesion with TIMI flow 0 for at least 3 months).

5. Target lesion is implanted with overlapping stents, whether planned or for bailout.

Note: If there is more than one target lesion, all target lesions must satisfy the angiographic eligibility criteria. Non-target lesion (i.e., lesions that do not meet the angiographic criteria listed above) treatments are not allowed during the index procedure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Valgimigli, MD

Role: PRINCIPAL_INVESTIGATOR

Bern University Hospital

Locations

Kepler Universitätsklinikum GmbH

Linz, UPR AUS, Austria

Onze-Lieve-Vrouwziekenhuis Campus Aalst

Aalst, Eflndrs, Belgium

UZ Gent

Ghent, Flemish, Belgium

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Jesse Ziekenhuis

Hasselt, Limburg, Belgium

Beijing AnZhen Hospital

Beijing, Beijing Municipality, China

The Second Hospital of Jilin University

Changchun, N China, China

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Bad-wur, Germany

Elisabeth-Krankenhaus Essen GmbH

Essen, N. RHIN, Germany

UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

Mainz, Rhinela, Germany

Herzzentrum Leipzig GmbH

Leipzig, Saxony, Germany

Segeberger Kliniken GmbH

Bad Segeberg, Schlesw, Germany

Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, , Germany

UKE Hamburg (Universitatsklinik Eppendorf)

Hamburg, , Germany

Prince of Wales Hospital

Hong Kong, Hong Ko, Hong Kong

Queen Elizabeth Hospital

Hong Kong, Hong Ko, Hong Kong

The University of Hong Kong (Queen Mary Hospital)

Hong Kong, HONG KO, Hong Kong

Clinica Mediterranea

Napoli, Campani, Italy

AOU Federico II - Università degli Studi di Napoli

Napoli, Campani, Italy

Az.Osp. Universitaria di Ferrara

Cona, Emi-rom, Italy

AOU di Parma

Parma, Emi-rom, Italy

Azienda Ospedaliero Universitaria Policlinico Umberto I

Rome, Lazio, Italy

Policlinico Universitario A. Gemelli

Rome, Lazio, Italy

Centro Cardiologico Monzino

Milan, Lombard, Italy

Istituto Clinico Humanitas

Rozzano, Lombard, Italy

Scheperziekenhuis

Emmen, Drenthe, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Friesld, Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, ZUID, Netherlands

Hospital de Santa Cruz

Carnaxide, Lisbon District, Portugal

Santa Maria Hospital

Lisbon, Lisbon District, Portugal

National Heart Centre Singapore

Singapore, Central, Singapore

Tan Tock Seng Hospital

Singapore, Central, Singapore

HCU Virgen de la Victoria

Málaga, Andalu, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabr, Spain

Hospital del Mar

Barcelona, Catalon, Spain

Hospital Clinic I Provincial de Barcelona

Barcelona, Catalon, Spain

Hospital Clinico Universitario de Valladolid

Valladolid, Cstleon, Spain

Hospital Alvaro Cunqueiro Dept of Interventional Cardiology

Vigo, Pontev, Spain

Hospital Universitario Doce de Octubre

Madrid, , Spain

Kantonsspital Aarau

Aarau, Basel, Switzerland

Center Inselspital Bern

Bern, , Switzerland

Luzerner Kantonsspital

Lucerne, , Switzerland

Chang Gung Memorial Hospital

Linkou District, Ntaiwan, Taiwan

National Taiwan University Hospital

Taipei, Ntaiwan, Taiwan

Taipei Veterans General Hospital (VGH)

Taipei, Ntaiwan, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Staiwan, Taiwan

Freeman Hospital

Newcastle upon Tyne, NE ENGL, United Kingdom

Craigavon Area Hospital

Portadown, Nirelnd, United Kingdom

Southampton University Hospital

Southampton, Soeast, United Kingdom

Royal Bournemouth Hospital

Bournemouth, Sowest, United Kingdom

Royal Devon and Exeter Hospital

Exeter, Sowest, United Kingdom

University Hospital of Wales

Cardiff, Wales, United Kingdom

Countries

Austria; Belgium; China; Germany; Hong Kong; Italy; Netherlands; Portugal; Singapore; Spain; Switzerland; Taiwan; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34794687 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33031789 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ABT-CIP-10235

Identifier Type: -

Identifier Source: org_study_id