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.
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
- Conditions the study is for
- Non-ST-elevation Myocardial Infarction, Multivessel Coronary Artery Disease
- 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.
Hans-Josef Feistritzer, MD, PhD; Assoc. Prof. contact
58 sites in 2 countries
Germany55 sites, 55 recruiting
- Recruiting
Zentralklinik Bad Berka, Klinik für Kardiologie
Bad Berka, 99437
Philipp Lauten, MD
- Not yet recruiting
Universitäts-Herzzentrum Bad Krozingen, Klinik für Kardiologie und Angiologie
Bad Krozingen, 79189
Miroslaw Ferenc, MD
- 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
- Not yet recruiting
Charité - University Medicine Berlin, Department of Internal Medicine and Cardiology, Campus Virchow Klinikum
Berlin, 13353
Tobias Trippel, MD
- Recruiting
Klinikum Bielefeld gem. GmbH, Klinik für Kardiologie und Internistische Intensivmedizin
Bielefeld, 33604
Christoph Stellbrink, MD
- Not yet recruiting
Klinik für Kardiologie und Rhythmologie, St. Josef Hospital, Universitätsklinikmum der Ruhr-Universität Bochum
Bochum, 44791
Arash Haghikia, MD
- Recruiting
Klinikum Links der Weser, Innere Medizin II
Bremen, 28277
Harm Wienbergen, MD
- Not yet recruiting
Städtisches Klinikum Dessau; Klinik für Innere Medizin II (Kardiologie, Angiologie, Diabetologie, internistische Intensivmedizin)
Dessau, 06847
Georg Fürnau, MD
- 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
- Not yet recruiting
Universitätsklinikum Freiburg, Klinik für Kardiologie und Angiologie
Freiburg im Breisgau, 79106
Christoph Oliver, MD
- 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
- Not yet 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
- 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
- Not yet recruiting
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II
Homburg, 66421
Saarraangan Kulenthiran, MD
- 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
- Not yet recruiting
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie und internistische Intensivmedizin
Kiel, 24105
Derk Frank, MD
- 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
- Not yet recruiting
Klinikum St. Georg gGmbH Klinik für Kardiologie und Internistische Intensivmedizin
Leipzig, 04229
Norbert Klein, MD
- 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
- Not yet recruiting
Universitätsklinikum Schleswig Holstein, Medizinische Klinik II, Campus Lübeck
Lübeck, 23538
Ingo Eitel, MD
- Recruiting
Klinikum der Stadt Ludwigshafen, Medizinische B Klinik
Ludwigshafen, 67063
Ralf Zahn, MD
- Not yet 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
- Recruiting
Universitätsmedizin Mannheim, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie und Internistische Intensivmedizin
Mannheim, 68167
Ibrahim Akin, MD
- Not yet recruiting
Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg, Klinik für Innere Medizin - Kardiologie, Angiologie und Intensivmedizin
Marburg, 35043
Georgios Chatzis, MD
- 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
- Not yet recruiting
Klinikum Neumarkt
Neumarkt, 92318
Ulrich Reiser, MD
- 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
- Not yet recruiting
Helios Vogtland-Klinikum Plauen
Plauen, 08529
Christian Bietau, MD
- 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
Austria3 sites, 3 recruiting
- Not yet 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
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 group | Role | What they receive |
|---|---|---|
| culprit-lesion-only revascularization | Experimental | 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. Receives: Procedure: Culprit-lesion revascularization |
| multivessel complete revascularization | Experimental | 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. 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.
Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction
Measured: During follow-up (2 years estimated average duration)
Secondary outcomes (12)
Rate of Cardiovascular death
Measured: During follow-up (2 years estimated average duration)
Rate of Rehospitalization for non-fatal myocardial infarction
Measured: During follow-up (2 years estimated average duration)
Rate of all-cause death
Measured: During follow-up (2 years estimated average duration)
Rate of ischemia-driven revascularization
Measured: During follow-up (2 years estimated average duration)
Rate of rehospitalization for heart failure
Measured: During follow-up (2 years estimated average duration)
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)
Rate of coronary artery bypass surgery
Measured: During follow-up (2 years estimated average duration)
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
Rate of bleeding
Measured: 6 months
Rate of stroke
Ischemic and Hemorrhagic
Measured: 6 months
Rate of contrast-induced acute kidney injury
AKIN grade I-III
Measured: 6 months
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.
- First posted27 Mar 2023
- Study start27 Oct 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-ST-elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Leipzig Heart Science gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Heart Center Leipzig at University of Leipzig, German Federal Ministry of Education and Research, IHF GmbH - Institut für Herzinfarktforschung, Stiftung IHF - Institut für Herzinfarktforschung
- Responsible party
- Sponsor
- Investigators
- Holger Thiele, MD, Prof. Dr., Study chair, Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI (-COMPLETE-NSTEMI-)
- ClinicalTrials.gov ID
- NCT05786131
- Acronym / sponsor ID
- CompleteNSTEMI / 2023-019
- Keywords
- NSTEMI, Multivessel coronary artery disease, culprit-lesion only PCI, multivessel percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,390 participants (estimated)
- Lead sponsor
- Leipzig Heart Science gGmbHUniversity, hospital or other
- Collaborators
- Heart Center Leipzig at University of Leipzig, German Federal Ministry of Education and Research, IHF GmbH - Institut für Herzinfarktforschung, Stiftung IHF - Institut für Herzinfarktforschung
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| culprit-lesion-only revascularization | Experimental | Procedure: Culprit-lesion revascularizationPatients 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. |
| multivessel complete revascularization | Experimental | Procedure: Culprit-lesion revascularization, Procedure: Non-culprit-lesion revascularizationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- NSTEMI as suggested by high-sensitivity troponin algorithms
- Multivessel coronary artery disease
- Identifiable culprit lesion
- Informed consent
Key exclusion criteria (10 listed)
- Age <18 years
- Cardiogenic shock
- Sustained ventricular tachycardia (VT) or ventricular fibrillation (VF)
- Contraindication for coronary revascularization
- Prior coronary artery bypass graft
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culprit-lesion revascularizationAlso: Culprit-lesion PCIPercutaneous coronary intervention of culprit-lesion | Procedure or surgery | culprit-lesion-only revascularization, multivessel complete revascularization |
| Non-culprit-lesion revascularizationAlso: multivessel PCIComplete percutaneous coronary intervention of all angiographically significant non-culprit lesions | Procedure or surgery | multivessel complete revascularization |
Primary outcome
Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction
Time frame: During follow-up (2 years estimated average duration)
12 secondary outcomes
Rate of Cardiovascular death
Time frame: During follow-up (2 years estimated average duration)
Rate of Rehospitalization for non-fatal myocardial infarction
Time frame: During follow-up (2 years estimated average duration)
Rate of all-cause death
Time frame: During follow-up (2 years estimated average duration)
Rate of ischemia-driven revascularization
Time frame: During follow-up (2 years estimated average duration)
Rate of rehospitalization for heart failure
Time frame: During follow-up (2 years estimated average duration)
Composite rate of all-cause death, rehospitalization for non-fatal myocardial infarction, or rehospitalization for ischemia-driven revascularization
Time frame: During follow-up (2 years estimated average duration)
Rate of coronary artery bypass surgery
Time frame: During follow-up (2 years estimated average duration)
Quality of Life (EQ-5D-5L)
Time frame: 12 months
Rate of bleeding
Time frame: 6 months
Rate of stroke
Time frame: 6 months
Rate of contrast-induced acute kidney injury
Time frame: 6 months
Rate of coronary procedure-related myocardial infarction
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Derived from this study: PubMed 40209841Feistritzer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hans-Josef Feistritzer, MD, PhD; Assoc. Prof. contact
Holger Thiele, MD, Prof. Dr. study chair
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
58 sites in 2 countries: see every site and its status.
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.