AzTrials
AzTrials

Non-ST-elevation Myocardial InfarctionCompleteNSTEMINCT05786131

Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI

A study testing Culprit-lesion revascularization and Non-culprit-lesion revascularization in people with Non-ST-elevation Myocardial Infarction and Multivessel Coronary Artery Disease, run by Leipzig Heart Science gGmbH at 58 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Culprit-lesion revascularization and Non-culprit-lesion revascularization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,390 participants
Where
58 sitesin 2 countries
Study dates
27 Oct 2023to 31 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

58 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Holger Thiele, MD, Prof. Dr. contact

+49 341 865-252025

holger.thiele@medizin.uni-leipzig.de

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

+49 341 865252579

COMPLE-NSTEMI@leipzig-heart.de

58 sites in 2 countries

Germany55 sites, 55 recruiting
  • Zentralklinik Bad Berka, Klinik für Kardiologie

    Bad Berka, 99437

    Philipp Lauten, MD

    Recruiting
  • Universitäts-Herzzentrum Bad Krozingen, Klinik für Kardiologie und Angiologie

    Bad Krozingen, 79189

    Miroslaw Ferenc, MD

    Not yet recruiting
  • Kerckhoff Klinik

    Bad Nauheim, 61231

    Maren Weferling, MD

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

    Bad Oeynhausen, 32545

    Regine Brinkmann, MD

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

    Berlin, 12683

    Sebastian Winkler, MD

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

    Berlin, 13353

    Tobias Trippel, MD

    Not yet recruiting
  • Klinikum Bielefeld gem. GmbH, Klinik für Kardiologie und Internistische Intensivmedizin

    Bielefeld, 33604

    Christoph Stellbrink, MD

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

    Bochum, 44791

    Arash Haghikia, MD

    Not yet recruiting
  • Klinikum Links der Weser, Innere Medizin II

    Bremen, 28277

    Harm Wienbergen, MD

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

    Dessau, 06847

    Georg Fürnau, MD

    Not yet recruiting
  • St. Johannes Hospital, Klinik für Innere Medizin I

    Dortmund, 44137

    Helge Möllmann, MD

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

    Dresden, 01307

    Axel Linke, MD

    Recruiting
  • Heinrich Heine Universitätsklinikum Düsseldorf Institut für Kardiologie, Pneumologie und Angiologie

    Düsseldorf, 40225

    Christian Jung, MD

    Recruiting
  • HELIOS Klinikum Erfurt, Medizinische Klinik III - Kardiologie

    Erfurt, 99089

    Alexander Lauten, MD

    Recruiting
  • Universitätsklinikum Erlangen, Medizinische Klinik 2

    Erlangen, 91054

    Stephan Achenbach, MD

    Recruiting
  • Elisabeth Krankenhaus Essen, Klinik für Kardiologie und Angiologie

    Essen, 45138

    Thomas Schmitz, MD

    Recruiting
  • Universitätsklinikum Essen, Klinik für Kardiologie und Angiologie

    Essen, 45147

    Tienush Rassaf, MD

    Recruiting
  • Universitätsklinikum Freiburg, Klinik für Kardiologie und Angiologie

    Freiburg im Breisgau, 79106

    Christoph Oliver, MD

    Not yet recruiting
  • Klinikum Fulda, Medizinischen Klinik 1 - Kardiologie, Angiologie und Intensivmedizin

    Fulda, 36043

    Volker Schächinger, MD

    Recruiting
  • Universitätsklinikum Gießen und Marburg GmbH, Medizinische Klinik I, Kardiologie

    Giessen, 35392

    Samuel Sossalla, MD

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

    Göttingen, 37075

    Karl Toischer, MD, Prof.

    Not yet recruiting
  • Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin B

    Greifswald, 17475

    Marcus Dörr, MD

    Not yet recruiting
  • Universitätsklinikum Halle (Saale), Klinik für Innere Medizin III

    Halle, 06120

    Daniel Sedding, MD

    Recruiting
  • Asklepios Klinik St. Georg, Kardiologie und Internistische Intensivmedizin

    Hamburg, 20099

    Eike Tigges, MD

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

    Hamburg, 20246

    Peter Clemmensen, MD

    Recruiting
  • Asklepios Klinik Altona

    Hamburg, 22763

    Felix Meincke, MD

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

    Heidelberg, 69120

    Haitham Abu Sharar, MD

    Recruiting
  • Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II

    Homburg, 66421

    Saarraangan Kulenthiran, MD

    Not yet recruiting
  • Universitätsklinikum Jena, Klinik für Innere Medizin I, Kardiologie, Angiologie, Internistische Intensivmedizin

    Jena, 07747

    Christian Schulze, MD

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

    Karlsruhe, 76137

    Claudius Jacobshagen, MD

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

    Kiel, 24105

    Derk Frank, MD

    Not yet recruiting
  • Asklepios Klinik Langen, Abteilung Medizinische Klinik I

    Langen, 63225

    Ralf Lehmann, MD

    Recruiting
  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologie

    Leipzig, 04103

    Christian Spies, MD

    Recruiting
  • Klinikum St. Georg gGmbH Klinik für Kardiologie und Internistische Intensivmedizin

    Leipzig, 04229

    Norbert Klein, MD

    Not yet recruiting
  • Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

    Leipzig, 04289

    Holger Thiele, MD, Prof. Dr., holger.thiele@medizin.uni-leipzig.de

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

    Recruiting
  • Universitätsklinikum Schleswig Holstein, Medizinische Klinik II, Campus Lübeck

    Lübeck, 23538

    Ingo Eitel, MD

    Not yet recruiting
  • Klinikum der Stadt Ludwigshafen, Medizinische B Klinik

    Ludwigshafen, 67063

    Ralf Zahn, MD

    Recruiting
  • Universitätsklinikum Magdeburg, Klinik für Kardiologie und Angiologie

    Magdeburg, 39120

    Alexander Schmeisser, MD

    Not yet recruiting
  • Brüderklinikum Julia Lanz, Theresienkrankenhaus

    Mannheim, 68165

    Ramon Tschierschke, MD

    Not yet recruiting
  • Universitätsmedizin Mannheim, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie und Internistische Intensivmedizin

    Mannheim, 68167

    Ibrahim Akin, MD

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

    Marburg, 35043

    Georgios Chatzis, MD

    Not yet recruiting
  • Klinikum der Universität München, Medizinische Klinik und Poliklinik I

    München, 80336

    Konstaninos Rizas, MD

    Recruiting
  • Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen

    München, 80636

    Adnan Kastrati, MD

    Recruiting
  • Klinikum Neumarkt

    Neumarkt, 92318

    Ulrich Reiser, MD

    Not yet recruiting
  • Klinikum Nürnberg, Medizinische Klinik 8 - Schwerpunkt Kardiologie, Universitätsklinik der Paracelsus Medizinischen Privatuniversität

    Nuremberg, 90471

    Fadil Ademaj, MD

    Recruiting
  • Universitätsklinik für Kardiologie am Klinikum Oldenburg

    Oldenburg, 26133

    Albrecht Elsässer, MD

    Recruiting
  • Helios Vogtland-Klinikum Plauen

    Plauen, 08529

    Christian Bietau, MD

    Not yet recruiting
  • Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II

    Regensburg, 93053

    Lars Maier, MD

    Recruiting
  • Universitätsmedizin Rostock, Zentrum für Innere Medizin, Abteilung für Kardiologie

    Rostock, 18057

    Alper Öner, MD

    Recruiting
  • Helios Kliniken Schwerin, Klinik für Kardiologie und Angiologie

    Schwerin, 19055

    Alexander Staudt, MD

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

    Trier, 54292

    Nikos Werner, MD

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

    Tübingen, 72076

    Tobias Geisler, MD

    Recruiting
  • Schwarzwald-Baar Klinikum VS, Studienteam Kardiologie

    Villingen-Schwenningen, 78052

    Sebastian Ewen, MD

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

    Wolfenbüttel, 38302

    Björn Billmann, MD

    Recruiting
  • Helios Klinikum Wuppertal, Herzkreislaufforschung

    Wuppertal, 72117

    Melchior Seyfarth, MD

    Recruiting

Other trials in Germany

Austria3 sites, 3 recruiting
  • LKH Univ. Klinikum Graz, Clinical Department of Cardiology

    Graz, 8036

    Gabor Thoth-Gayor, MD

    Not yet recruiting
  • Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III

    Innsbruck, 6020

    Sebastian Reinstadler, MD

    Not yet recruiting
  • Klinik Ottakring, 3. medizinische Abteilung

    Vienna, 1160

    Alexander Geppert, MD

    Not yet recruiting

Other trials in Austria

About this study

Official title: Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI (-COMPLETE-NSTEMI-)

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.

Read the detailed description

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.

Being tested
Culprit-lesion revascularization, Non-culprit-lesion revascularization
Keywords
NSTEMI, Multivessel coronary artery disease, culprit-lesion only PCI, multivessel percutaneous coronary intervention
Medical subject headings
Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Culprit-lesion revascularizationProcedure or surgery

    Also called Culprit-lesion PCI

    Percutaneous coronary intervention of culprit-lesion

  • Non-culprit-lesion revascularizationProcedure or surgery

    Also called multivessel PCI

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

Study groups in NCT05786131
Study groupRoleWhat they receive
culprit-lesion-only revascularizationExperimentalPatients 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.
Receives: Procedure: Culprit-lesion revascularization
multivessel complete revascularizationExperimentalPatients 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.
Receives: Procedure: Culprit-lesion revascularization; Procedure: Non-culprit-lesion revascularization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction

    Measured: During follow-up (2 years estimated average duration)

Secondary outcomes (12)
  1. Rate of Cardiovascular death

    Measured: During follow-up (2 years estimated average duration)

  2. Rate of Rehospitalization for non-fatal myocardial infarction

    Measured: During follow-up (2 years estimated average duration)

  3. Rate of all-cause death

    Measured: During follow-up (2 years estimated average duration)

  4. Rate of ischemia-driven revascularization

    Measured: During follow-up (2 years estimated average duration)

  5. Rate of rehospitalization for heart failure

    Measured: During follow-up (2 years estimated average duration)

  6. Composite rate of all-cause death, rehospitalization for non-fatal myocardial infarction, or rehospitalization for ischemia-driven revascularization

    Measured: During follow-up (2 years estimated average duration)

  7. Rate of coronary artery bypass surgery

    Measured: During follow-up (2 years estimated average duration)

  8. Quality of Life (EQ-5D-5L)

    European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Score 1-5 for each dimension, 1 means best outcome EQ VAS score between 0 and 100; higher score means better outcome

    Measured: 12 months

  9. Rate of bleeding

    Measured: 6 months

  10. Rate of stroke

    Ischemic and Hemorrhagic

    Measured: 6 months

  11. Rate of contrast-induced acute kidney injury

    AKIN grade I-III

    Measured: 6 months

  12. Rate of coronary procedure-related myocardial infarction

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2023
  2. Study start27 Oct 2023
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,390 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05786131
Sponsor's protocol ID
2023-019
Acronym
CompleteNSTEMI
Status last verified
Jan 2025
First submitted
14 Mar 2023
Last updated
16 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40209841

Questions about this trial

What is this clinical trial studying?

A study testing Culprit-lesion revascularization and Non-culprit-lesion revascularization in people with Non-ST-elevation Myocardial Infarction and Multivessel Coronary Artery Disease, run by Leipzig Heart Science gGmbH at 58 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Holger Thiele, MD, Prof. Dr. (+49 341 865-252025, holger.thiele@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction (time frame: During follow-up (2 years estimated average duration)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05786131, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.

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