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Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI

NCT ID: NCT05786131

Last Updated: 2025-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-27

Study Completion Date

2027-07-31

Brief Summary

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Prospective, randomized, controlled, multicenter, open-label trial to study whether multivessel percutaneous coronary intervention (PCI) is superior over culprit-lesion only PCI in patients with non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease.

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Detailed Description

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The complete revascularization versus culprit lesion only PCI in NSTEMI (COMPLETE-NSTEMI) trial aims to investigate whether multivessel complete PCI is superior over culprit-lesion only PCI in patients with NSTEMI and multivessel coronary artery disease.

Conditions

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Non-ST-elevation Myocardial Infarction Multivessel Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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culprit-lesion-only revascularization

Patients will receive optimal medical therapy without further revascularization of non-culprit lesions (neither during index hospitalization nor during follow-up). Angina pectoris will be treated medically as recommended in the chronic coronary syndrome guidelines. Revascularization of non-culprit lesions will only be permitted if at least one bailout criteria is met.

Group Type EXPERIMENTAL

Culprit-lesion revascularization

Intervention Type PROCEDURE

Percutaneous coronary intervention of culprit-lesion

multivessel complete revascularization

Patients will receive complete revascularization of all angiographically significant non-culprit lesions, either during the index procedure, the index hospitalization, or staged within 45 days after PCI of the culprit lesion.

Group Type EXPERIMENTAL

Culprit-lesion revascularization

Intervention Type PROCEDURE

Percutaneous coronary intervention of culprit-lesion

Non-culprit-lesion revascularization

Intervention Type PROCEDURE

Complete percutaneous coronary intervention of all angiographically significant non-culprit lesions

Interventions

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Culprit-lesion revascularization

Percutaneous coronary intervention of culprit-lesion

Intervention Type PROCEDURE

Non-culprit-lesion revascularization

Complete percutaneous coronary intervention of all angiographically significant non-culprit lesions

Intervention Type PROCEDURE

Other Intervention Names

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Culprit-lesion PCI multivessel PCI

Eligibility Criteria

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Inclusion Criteria

* NSTEMI as suggested by high-sensitivity troponin algorithms
* Multivessel coronary artery disease
* Identifiable culprit lesion
* Informed consent

Exclusion Criteria

* Age \<18 years
* Cardiogenic shock
* Sustained ventricular tachycardia (VT) or ventricular fibrillation (VF)
* Contraindication for coronary revascularization
* Prior coronary artery bypass graft
* Indication for coronary artery bypass graft surgery
* Non-culprit lesion located in the left main coronary artery
* Co-morbidity with life expectancy less than 6 months
* Type 2 myocardial infarction
* Pregnancy and breast feeding period
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart Center Leipzig at University of Leipzig

UNKNOWN

Sponsor Role collaborator

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

IHF GmbH - Institut für Herzinfarktforschung

OTHER

Sponsor Role collaborator

Stiftung IHF - Institut für Herzinfarktforschung

UNKNOWN

Sponsor Role collaborator

Leipzig Heart Science gGmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Holger Thiele, MD, Prof. Dr.

Role: STUDY_CHAIR

Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

Locations

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LKH Univ. Klinikum Graz, Clinical Department of Cardiology

Graz, , Austria

Site Status NOT_YET_RECRUITING

Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III

Innsbruck, , Austria

Site Status NOT_YET_RECRUITING

Klinik Ottakring, 3. medizinische Abteilung

Vienna, , Austria

Site Status NOT_YET_RECRUITING

Zentralklinik Bad Berka, Klinik für Kardiologie

Bad Berka, , Germany

Site Status RECRUITING

Universitäts-Herzzentrum Bad Krozingen, Klinik für Kardiologie und Angiologie

Bad Krozingen, , Germany

Site Status NOT_YET_RECRUITING

Kerckhoff Klinik

Bad Nauheim, , Germany

Site Status RECRUITING

Herz- und Diabeteszentrum NRW, Universitätsklinikum der Ruhr-Universität Bochum, Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie

Bad Oeynhausen, , Germany

Site Status RECRUITING

BG Klinikum Unfallkrankenhaus Berlin gGmbH, Klinik für Innere Medizin/Kardiologie

Berlin, , Germany

Site Status RECRUITING

Charité - University Medicine Berlin, Department of Internal Medicine and Cardiology, Campus Virchow Klinikum

Berlin, , Germany

Site Status NOT_YET_RECRUITING

Klinikum Bielefeld gem. GmbH, Klinik für Kardiologie und Internistische Intensivmedizin

Bielefeld, , Germany

Site Status RECRUITING

Klinik für Kardiologie und Rhythmologie, St. Josef Hospital, Universitätsklinikmum der Ruhr-Universität Bochum

Bochum, , Germany

Site Status NOT_YET_RECRUITING

Klinikum Links der Weser, Innere Medizin II

Bremen, , Germany

Site Status RECRUITING

Städtisches Klinikum Dessau; Klinik für Innere Medizin II (Kardiologie, Angiologie, Diabetologie, internistische Intensivmedizin)

Dessau, , Germany

Site Status NOT_YET_RECRUITING

St. Johannes Hospital, Klinik für Innere Medizin I

Dortmund, , Germany

Site Status RECRUITING

Herzzentrum Dresden GmbH, Universitätsklinik an der Technischen Universität Dresden, Klinik für Innere Medizin und Kardiologie

Dresden, , Germany

Site Status RECRUITING

Heinrich Heine Universitätsklinikum Düsseldorf Institut für Kardiologie, Pneumologie und Angiologie

Düsseldorf, , Germany

Site Status RECRUITING

HELIOS Klinikum Erfurt, Medizinische Klinik III - Kardiologie

Erfurt, , Germany

Site Status RECRUITING

Universitätsklinikum Erlangen, Medizinische Klinik 2

Erlangen, , Germany

Site Status RECRUITING

Elisabeth Krankenhaus Essen, Klinik für Kardiologie und Angiologie

Essen, , Germany

Site Status RECRUITING

Universitätsklinikum Essen, Klinik für Kardiologie und Angiologie

Essen, , Germany

Site Status RECRUITING

Universitätsklinikum Freiburg, Klinik für Kardiologie und Angiologie

Freiburg im Breisgau, , Germany

Site Status NOT_YET_RECRUITING

Klinikum Fulda, Medizinischen Klinik 1 - Kardiologie, Angiologie und Intensivmedizin

Fulda, , Germany

Site Status RECRUITING

Universitätsklinikum Gießen und Marburg GmbH, Medizinische Klinik I, Kardiologie

Giessen, , Germany

Site Status RECRUITING

University Medical Center Göttingen, Department of Cardiology and Pneumology, Georg-August University

Göttingen, , Germany

Site Status NOT_YET_RECRUITING

Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin B

Greifswald, , Germany

Site Status NOT_YET_RECRUITING

Universitätsklinikum Halle (Saale), Klinik für Innere Medizin III

Halle, , Germany

Site Status RECRUITING

Asklepios Klinik St. Georg, Kardiologie und Internistische Intensivmedizin

Hamburg, , Germany

Site Status RECRUITING

Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH, Klinik für Kardiologie

Hamburg, , Germany

Site Status RECRUITING

Asklepios Klinik Altona

Hamburg, , Germany

Site Status RECRUITING

Klinik für Kardiologie, Angiologie und Pneumologie, Medizinische Klinik 3, Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status RECRUITING

Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II

Homburg, , Germany

Site Status NOT_YET_RECRUITING

Universitätsklinikum Jena, Klinik für Innere Medizin I, Kardiologie, Angiologie, Internistische Intensivmedizin

Jena, , Germany

Site Status RECRUITING

Vincentius-Diakonissen-Kliniken gAG Medizinische Klinik III, Kardiologie, Intensivmedizin, Angiologie

Karlsruhe, , Germany

Site Status RECRUITING

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie und internistische Intensivmedizin

Kiel, , Germany

Site Status NOT_YET_RECRUITING

Asklepios Klinik Langen, Abteilung Medizinische Klinik I

Langen, , Germany

Site Status RECRUITING

Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologie

Leipzig, , Germany

Site Status RECRUITING

Klinikum St. Georg gGmbH Klinik für Kardiologie und Internistische Intensivmedizin

Leipzig, , Germany

Site Status NOT_YET_RECRUITING

Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

Leipzig, , Germany

Site Status RECRUITING

Klinikum der Stadt Ludwigshafen, Medizinische B Klinik

Ludwigshafen, , Germany

Site Status RECRUITING

Universitätsklinikum Schleswig Holstein, Medizinische Klinik II, Campus Lübeck

Lübeck, , Germany

Site Status NOT_YET_RECRUITING

Universitätsklinikum Magdeburg, Klinik für Kardiologie und Angiologie

Magdeburg, , Germany

Site Status NOT_YET_RECRUITING

Brüderklinikum Julia Lanz, Theresienkrankenhaus

Mannheim, , Germany

Site Status NOT_YET_RECRUITING

Universitätsmedizin Mannheim, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie und Internistische Intensivmedizin

Mannheim, , Germany

Site Status RECRUITING

Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg, Klinik für Innere Medizin - Kardiologie, Angiologie und Intensivmedizin

Marburg, , Germany

Site Status NOT_YET_RECRUITING

Klinikum der Universität München, Medizinische Klinik und Poliklinik I

München, , Germany

Site Status RECRUITING

Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen

München, , Germany

Site Status RECRUITING

Klinikum Neumarkt

Neumarkt, , Germany

Site Status NOT_YET_RECRUITING

Klinikum Nürnberg, Medizinische Klinik 8 - Schwerpunkt Kardiologie, Universitätsklinik der Paracelsus Medizinischen Privatuniversität

Nuremberg, , Germany

Site Status RECRUITING

Universitätsklinik für Kardiologie am Klinikum Oldenburg

Oldenburg, , Germany

Site Status RECRUITING

Helios Vogtland-Klinikum Plauen

Plauen, , Germany

Site Status NOT_YET_RECRUITING

Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II

Regensburg, , Germany

Site Status RECRUITING

Universitätsmedizin Rostock, Zentrum für Innere Medizin, Abteilung für Kardiologie

Rostock, , Germany

Site Status RECRUITING

Helios Kliniken Schwerin, Klinik für Kardiologie und Angiologie

Schwerin, , Germany

Site Status RECRUITING

Krankenhaus der Barmherzigen Brüder Trier, Herzzentrum Innere Medizin III - Kardiologie

Trier, , Germany

Site Status RECRUITING

Universitätsklinikum Tübingen, Medizinische Klinik, Innere Medizin III, Kardiologie und Angiologie

Tübingen, , Germany

Site Status RECRUITING

Schwarzwald-Baar Klinikum VS, Studienteam Kardiologie

Villingen-Schwenningen, , Germany

Site Status RECRUITING

Städtisches Klinikum Wolfenbüttel gGmbH, Klinik für Innere Medizin - Kardiologie,

Wolfenbüttel, , Germany

Site Status RECRUITING

Helios Klinikum Wuppertal, Herzkreislaufforschung

Wuppertal, , Germany

Site Status RECRUITING

Countries

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Austria Germany

Central Contacts

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Holger Thiele, MD, Prof. Dr.

Role: CONTACT

[email protected]
+49 341 865-252025

Hans-Josef Feistritzer, MD, PhD; Assoc. Prof.

Role: CONTACT

[email protected]
+49 341 865252579

Facility Contacts

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Gabor Thoth-Gayor, MD

Role: primary

Sebastian Reinstadler, MD

Role: primary

Alexander Geppert, MD

Role: primary

Philipp Lauten, MD

Role: primary

Miroslaw Ferenc, MD

Role: primary

Maren Weferling, MD

Role: primary

Regine Brinkmann, MD

Role: primary

Sebastian Winkler, MD

Role: primary

Tobias Trippel, MD

Role: primary

Christoph Stellbrink, MD

Role: primary

Arash Haghikia, MD

Role: primary

Harm Wienbergen, MD

Role: primary

Georg Fürnau, MD

Role: primary

Helge Möllmann, MD

Role: primary

Axel Linke, MD

Role: primary

Christian Jung, MD

Role: primary

Alexander Lauten, MD

Role: primary

Stephan Achenbach, MD

Role: primary

Thomas Schmitz, MD

Role: primary

Tienush Rassaf, MD

Role: primary

Christoph Oliver, MD

Role: primary

Volker Schächinger, MD

Role: primary

Samuel Sossalla, MD

Role: primary

Karl Toischer, MD, Prof.

Role: primary

Marcus Dörr, MD

Role: primary

Daniel Sedding, MD

Role: primary

Eike Tigges, MD

Role: primary

Peter Clemmensen, MD

Role: primary

Felix Meincke, MD

Role: primary

Haitham Abu Sharar, MD

Role: primary

Saarraangan Kulenthiran, MD

Role: primary

Christian Schulze, MD

Role: primary

Claudius Jacobshagen, MD

Role: primary

Derk Frank, MD

Role: primary

Ralf Lehmann, MD

Role: primary

Christian Spies, MD

Role: primary

Norbert Klein, MD

Role: primary

Holger Thiele, MD, Prof. Dr.

Role: primary

[email protected]

Ralf Zahn, MD

Role: primary

Ingo Eitel, MD

Role: primary

Alexander Schmeisser, MD

Role: primary

Ramon Tschierschke, MD

Role: primary

Ibrahim Akin, MD

Role: primary

Georgios Chatzis, MD

Role: primary

Konstaninos Rizas, MD

Role: primary

Adnan Kastrati, MD

Role: primary

Ulrich Reiser, MD

Role: primary

Fadil Ademaj, MD

Role: primary

Albrecht Elsässer, MD

Role: primary

Christian Bietau, MD

Role: primary

Lars Maier, MD

Role: primary

Alper Öner, MD

Role: primary

Alexander Staudt, MD

Role: primary

Nikos Werner, MD

Role: primary

Tobias Geisler, MD

Role: primary

Sebastian Ewen, MD

Role: primary

Björn Billmann, MD

Role: primary

Melchior Seyfarth, MD

Role: primary

References

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Feistritzer HJ, Jobs A, Zeymer U, Schneider S, Lauten P, Ferenc M, Weferling M, Brinkmann R, Winkler S, Landmesser U, Trippel T, Stellbrink C, Wienbergen H, Furnau G, Mollmann H, Linke A, Jung C, Lauten A, Achenbach S, Rassaf T, Schmitz T, Cremer S, Olivier C, Schachinger V, Sossalla S, Toischer K, Templin C, Sedding D, Clemmensen P, Tigges E, Meincke F, Sharar HA, Kulenthiran S, Schulze PC, Jacobshagen C, Frank D, Baldus S, Lehmann R, Spies C, Klein N, Eitel I, Zahn R, Schmeisser A, Gori T, Lurz P, Akin I, Chatzis G, Rizas K, Kessler T, Ademaj F, Elsasser A, Maier L, Oner A, Staudt A, Werner N, Geisler T, Kessler M, Ferrari MW, Seyfarth M, Nordbeck P, Ewen S, Bietau C, Haghikia A, Reinstadler SJ, Geppert A, Hosler N, Toth-Gayor G, Billmann B, Tschierschke R, Schmidt C, Fichtlscherer S, Thiele H; COMPLETE-NSTEMI Investigators. Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease - Design and rationale of the randomized COMPLETE-NSTEMI trial. Am Heart J. 2025 Sep;287:94-106. doi: 10.1016/j.ahj.2025.04.007. Epub 2025 Apr 8.

Reference Type DERIVED
PMID: 40209841 (View on PubMed)

Other Identifiers

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2023-019

Identifier Type: -

Identifier Source: org_study_id

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