Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
Study NCT ID:
NCT05491200
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2022-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1656}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2022-08-05', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'non inferiority of a Prasugrel-based short DAPT (30-45 days) followed by Prasugrel 11 month monotherapy versus standard 12 month DAPT regimen', 'timeFrame': '11 months', 'description': 'Incidence of Net Adverse Clinical Events (NACE) at 11 months post DAPT randomization as composite of all cause death, MI, stroke or BARC bleeding 3 or 5'}, {'measure': 'superiority of an Optical Coherence Tomography (OCT)-guided revascularization completion as compared to a standard angiography-guided revascularization completion.', 'timeFrame': 'immediately after the procedure', 'description': 'Post-procedural Minimal Stent Area (MSA)'}], 'secondaryOutcomes': [{'measure': 'Composite of MACCE', 'timeFrame': '3 year', 'description': 'Composite of the number of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiovascular death, myocardial infarction, or ischaemic stroke'}, {'measure': 'BARC type 3 or 5 events', 'timeFrame': '1 and 3 years', 'description': 'Number of BARC type 3 or 5 events occuring'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ST Elevated Myocardial Infarction', 'Dual Antiplatelet Therapy']}, 'referencesModule': {'references': [{'pmid': '40375771', 'type': 'DERIVED', 'citation': 'Paradies V, Van Mieghem NM, Oemrawsingh RM, Richardt G, Esposito G, Campo G, Burzotta F, Canova P, Linke A, Porto I, Trabattoni D, Teeuwen K, Adriaenssens T, Kala P, Stankovic G, Vliet RV, Giacoppo D, Daemen J, Smits PC. Prasugrel monotherapy versus standard DAPT in STEMI patients with OCT-guided or angio-guided complete revascularisation: design and rationale of the randomised, multifactorial COMPARE STEMI ONE trial. EuroIntervention. 2025 May 16;21(10):571-580. doi: 10.4244/EIJ-D-24-00829.'}]}, 'descriptionModule': {'briefSummary': 'The study is a multi-centre, Open-label, Randomized Controlled, 1:1 trial comparing Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy versus standard DAPT regimen in STEMI patients in terms of safety and efficacy endpoints.\n\nIn the subgroup of STEMI patients with MVD, a sub-randomization will allow a comparison between a complete revascularization OCT-guided versus complete revascularization angiography-guided stent in terms of efficacy and safety endpoints.', 'detailedDescription': 'Consecutive patients with STEMI planned for pPCI will be screened for eligibility criteria and treated as per standard of care with ASA and Prasugrel 60 mg loading dose. The culprit lesion will be treated during the index procedure. Non culprit lesions in patients with MVD will be treated during staged procedure(s), in any case last instalment of staged procedure(s) should be scheduled within 15 days after index procedure. Complete revascularization of non culprit lesions will be allocated to either OCT- or angio-guided strategy (OCT randomization). At 30-45 days follow-up after index procedure, if inclusion criteria are met, patients will be randomized to prasugrel monotherapy or standard DAPT regimen (DAPT randomization).\n\nThe follow-up duration is 35 months after DAPT randomization, i.e. clinical outcomes will be analysed at 11 and 35 months after DAPT randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEligibility at index procedure\n\nAll STEMI patients who are planned to be treated with PCI:\n\nST segment elevation myocardial infarction\n\nChest discomfort suggestive of cardiac ischemia ≥20 min at rest with 1 of the following ECG features:\n\n* ST segment elevation ≥2 contiguous ECG leads\n* new or presumably new left bundle branch block\n\nIn patients with multivessel disease, treatment only of the culprit lesion / target vessel during primary PCI is recommended.\n\nEligibility at 30-45 days\n\n* All patients who have provided informed consent\n* Compliance to DAPT with no regimen modifications (Non-adherence Academic Research Consortium 0)\n* No occurrence of significant event (such as MI, unplanned revascularisation, stent thrombosis, stroke, major vascular complication/bleeding BARC Types 3 or greater).\n* Successful revascularization: - Successful delivery and deployment of the Study device(s), with final residual stenosis of \\<30% (visually) for all target lesions.\n* Complete revascularization performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 15 days from the index procedure. Physiologic assessment highly recommended for lesions with stenosis between 50% and 90%.\n\nExclusion criteria\n\n* Patients on oral anticoagulation\n* Contraindication to P2Y12 inhibitors and/or to Cardioaspirin or to any of the excipients (hypersensitivity, history of any stroke or transient ischemic attack within the last 12 months, active bleeding or haemorrhagic diathesis, fibrin-specific fibrinolytic therapy less than 24 h before randomization, severe hepatic dysfunction (Child-Pugh C), history of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines, history of gastrointestinal perforation or acute gastrointestinal ulcers, severe cardiac failure (NYHA grade III or IV), combination with methotrexate at doses of 15 mg/week or more).\n* Patients who have received P2Y12 inhibitors other than Prasugrel in the ambulance (Ticagrelor or Clopidogrel loading dose) or are already on P2Y12 inhibitors, may be enrolled in the protocol, provided that the Prasugrel loading dose is administered at admission, according to current guidelines recommendations (see section 5.2.2).\n* Concomitant oral or i.v. therapy with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice \\>1L/day), CYP3A substrates with narrow therapeutic indices (e.g., cyclosporine, quinidine), or strong CYP3A inducers (e.g., rifampin), - rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital\n* Platelet count \\<100.000/μL at the time of screening\n* Anemia (hemoglobin \\<10 g/dL) at the time of screening\n* Comorbidities associated with life expectancy \\<1 year\n* Pregnancy, giving birth within the last 90 days, or lactation (see appendix III for women of childbearing potential)\n* PCI indication for stent thrombosis or previous history of definite stent thrombosis\n* Non-deferrable major surgery on DAPT after PCI\n* Cardiogenic shock\n* Out of hospital cardiac arrest (OHCA) unless survivors of ventricular arrythmia with prompt return of spontaneous circulation (ROSC)\n* Patients with severe renal impairment: creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR).\n* Patients participating in another interventional (device of drug trial) within the previous 12 months or patients to whom an investigational drug was administered in the 30 days prior to screening, or 5 half-lives of the study drug, whichever is longer.\n* No informed consent'}, 'identificationModule': {'nctId': 'NCT05491200', 'briefTitle': 'Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients', 'organization': {'class': 'OTHER', 'fullName': 'Research Maatschap Cardiologen Rotterdam Zuid'}, 'officialTitle': 'COMPARE STEMI ONE- Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients Treated With OCT-guided vs aNgio-guided completE Revascularization', 'orgStudyIdInfo': {'id': 'RM21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prasugrel-based short DAPT', 'description': 'Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy for 11 months.', 'interventionNames': ['Drug: Prasugrel based short DAPT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prasugrel based standard DAPT', 'description': 'Prasugrel-based DAPT for 1 year', 'interventionNames': ['Drug: Prasugrel based standard DAPT']}, {'type': 'EXPERIMENTAL', 'label': 'OCT guided non-culprit lesion', 'description': 'Complete revascularization of non culprit lesions guided by OCT', 'interventionNames': ['Device: OCT guided revascularization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Angio guided non-culprit lesion', 'description': 'Complete revascularization of non culprit lesions guided by Angio', 'interventionNames': ['Device: Angio guided revascularization']}], 'interventions': [{'name': 'Prasugrel based short DAPT', 'type': 'DRUG', 'description': 'Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy versus', 'armGroupLabels': ['Prasugrel-based short DAPT']}, {'name': 'Prasugrel based standard DAPT', 'type': 'DRUG', 'description': 'Prasugrel based DAPT for 1 year', 'armGroupLabels': ['Prasugrel based standard DAPT']}, {'name': 'OCT guided revascularization', 'type': 'DEVICE', 'description': 'OCT guided revascularization of the non-culprit lesions', 'armGroupLabels': ['OCT guided non-culprit lesion']}, {'name': 'Angio guided revascularization', 'type': 'DEVICE', 'description': 'Angio guided revascularization of the non-culprit lesions', 'armGroupLabels': ['Angio guided non-culprit lesion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bonheiden', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Willem de Wilde, PhD', 'role': 'CONTACT'}, {'name': 'Willem de Wilde, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Imelda Bonheiden', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'city': 'Bruges', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Patrick Coussement, PhD', 'role': 'CONTACT'}, {'name': 'Patrick Coussement, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AZ St.Jan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Genk', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Koen Amelot, PhD', 'role': 'CONTACT'}, {'name': 'Koen Amelot, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ZOL Genk', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Leuven', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Tom Adreiaansen, PhD', 'role': 'CONTACT'}, {'name': 'Tom Adreiaansen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Roeselare', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Maarten v Haverbeke', 'role': 'CONTACT'}, {'name': 'Maarten v Haverbeke, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AZ Delta', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'city': 'Brno', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Petr Kala, PhD', 'role': 'CONTACT'}, {'name': 'Petr Kala, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'FN BRNO', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Hradec Králové', 'status': 'NOT_YET_RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Pavel Cervinka, PhD', 'role': 'CONTACT'}, {'name': 'Pavel Cervinka, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Masaryk Hospital Usti nad Labem -', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Prague', 'status': 'NOT_YET_RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Tomas Kovarnik, PhD', 'role': 'CONTACT'}, {'name': 'Tomas Kovarnik, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charles University Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Bad Oldesloe', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ralph Tölg, PhD', 'role': 'CONTACT'}, {'name': 'Ralph Tölg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asklepios Klinik Bad Oldesloe', 'geoPoint': {'lat': 53.81167, 'lon': 10.37417}}, {'city': 'Bad Segeberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Arief Kurniadi, PhD', 'role': 'CONTACT'}, {'name': 'Arief Kurniadi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Segeberger Kliniken', 'geoPoint': {'lat': 53.93775, 'lon': 10.30745}}, {'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Axel Linke, PhD', 'role': 'CONTACT'}, {'name': 'Axel Linke', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University hospital Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Bergamo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Angelo Canova, MD, PhD', 'role': 'CONTACT', 'email': 'pacanova@asst-pg23.it'}, {'name': 'Paolo Angelo Canova, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Papa Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Ferrara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gianluca Campo, PhD', 'role': 'CONTACT'}, {'name': 'Gianluca Campo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'I. Porto, PhD', 'role': 'CONTACT'}, {'name': 'I. Porto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniela Trabattoni, MD, PhD', 'role': 'CONTACT', 'email': 'daniela.trabattoni@cardiologicomonzino.it'}, {'name': 'Daniela Trabattoni, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro Cardiologico Monzino IRCCS', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'G. Esposito, PhD', 'role': 'CONTACT'}, {'name': 'G. Esposito, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'F. Burzotta, PhD', 'role': 'CONTACT'}, {'name': 'F. Burzotta, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Dordrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Rohit Oemrawsingh, PhD', 'role': 'CONTACT'}, {'name': 'Rohit Oemrawsingh', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Albert Schweitzer ziekenhuis', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'city': 'Eindhoven', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Koen Teeuwen, MD, PhD', 'role': 'CONTACT', 'email': 'koen.teeuwen@catharinaziekenhuis.nl', 'phone': '0402399111'}, {'name': 'MD, Phd', 'role': 'CONTACT', 'email': 'koen.teeuwen@catharinaziekenhuis.nl', 'phone': 'Koen'}], 'facility': 'Catherina ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Niels v Royen', 'role': 'CONTACT'}, {'name': 'Niels v Royen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'RadboudUMC', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Nicolas van Mieghem, PHD', 'role': 'CONTACT'}, {'name': 'Nicolas v Mieghem', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Valeria Paradies', 'role': 'CONTACT', 'email': 'paradiesV2@maasstadziekenhuis.nl', 'phone': '+31621620153'}, {'name': 'Valeria Paradies', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maasstadziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'The Hague', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Samer Somi, PhD', 'role': 'CONTACT'}, {'name': 'Samer Somi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Haga hospital', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'city': 'Belgrade', 'status': 'NOT_YET_RECRUITING', 'country': 'Serbia', 'contacts': [{'name': 'Mihajlo Farkić, PhD', 'role': 'CONTACT'}, {'name': 'Mihajlo Farkić, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute for CVD Dedinje', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Belgrade', 'status': 'NOT_YET_RECRUITING', 'country': 'Serbia', 'contacts': [{'name': 'Dejan Milasinovic, PhD', 'role': 'CONTACT'}, {'name': 'Dejan Milasinovic, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University clinical center of Serbia', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Kamenitz', 'status': 'NOT_YET_RECRUITING', 'country': 'Serbia', 'contacts': [{'name': 'Milovan Petrovic, PhD', 'role': 'CONTACT'}, {'name': 'Milovan Petrovic, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute for CVD Vojvodine', 'geoPoint': {'lat': 45.22334, 'lon': 19.84263}}], 'centralContacts': [{'name': 'Valeria Paradies, MD', 'role': 'CONTACT', 'email': 'paradiesV2@maasstadziekenhuis.nl', 'phone': '+31621620153'}, {'name': 'Ria van Vliet', 'role': 'CONTACT', 'email': 'vlietM@maasstadziekenhuis.nl', 'phone': '+31644162844'}], 'overallOfficials': [{'name': 'Valeria Paradies, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Maatschap Cardiologen Rotterdam Zuid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research Maatschap Cardiologen Rotterdam Zuid', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}