Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-03-23 @ 11:48 AM
Study NCT ID:
NCT03445728
Status:
COMPLETED
Last Update Posted:
2021-11-24
First Post:
2018-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
China-Administration of Nicorandil Group（CHANGE）
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020108', 'term': 'Nicorandil'}], 'ancestors': [{'id': 'D009566', 'term': 'Nitrates'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-18', 'studyFirstSubmitDate': '2018-02-02', 'studyFirstSubmitQcDate': '2018-02-20', 'lastUpdatePostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infarct size as measured by cardiac MRI', 'timeFrame': '7 days after primary PCI', 'description': 'The myocardial infarct size was derived by measuring the area of delay-enhanced image-enhanced MRI, which was judged and analyzed by two experienced MRI cardiac diagnosticians.'}], 'secondaryOutcomes': [{'measure': 'Infarct size as measured by cardiac MRI', 'timeFrame': '6 months after PCI', 'description': "The myocardial infarct size was derived from the program's automatic analysis of delayed enhancement images."}, {'measure': 'Corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC)', 'timeFrame': '5 minutes after stent implantation during PCI', 'description': 'the starting point is the number of frames in which the contrast agent completely or nearly completely filled the beginning of the coronary artery and touched both sides of the coronary vessel wall, and the end point is the number of frames in which the contrast agent entered the distal branch vessel and developed a specific anatomical marker'}, {'measure': 'Incidence of slow flow/no-reflow', 'timeFrame': '5 minutes after stent implantation during PCI', 'description': 'When scanning at a rate of 15 frames per second, cTFC \\> 27 frames per second was used as the criterion for the diagnosis of slow blood flow after primary PCI'}, {'measure': 'ST-segment fall rate of electrocardiogram (ECG)', 'timeFrame': '2 hours after the procedure', 'description': 'Complete ST-segment resolution at 2 h after PCI'}, {'measure': 'Serum creatinine kinase (CK-MB) level', 'timeFrame': 'Baseline, 6, 12, 18, 24 hours after the PCI', 'description': 'Change of serum creatinine kinase'}, {'measure': 'Edema size (LV area %) measured by cardiac MRI', 'timeFrame': '7 days after the procedure', 'description': 'Edema size'}, {'measure': 'Microvascular obstructionmeasured by cardiac MRI', 'timeFrame': '7 days after the procedure', 'description': 'Microvascular obstructionmeasured'}, {'measure': 'LV Ejection fraction (%) as measured by cardiac MRI', 'timeFrame': '7 days after the procedure', 'description': 'LV Ejection fraction in early phase'}, {'measure': 'LV Ejection fraction (%) as measured by cardiac MRI', 'timeFrame': '6 months after the procedure', 'description': 'LV Ejection fraction in late phase'}, {'measure': 'MACE', 'timeFrame': 'up to 12 months', 'description': 'all-cause death, cardiovascular death, , Rehospitalization for heart failure, Unplanned PCI After PPCI'}, {'measure': 'CIN', 'timeFrame': '48-72 hours after primary PCI', 'description': 'contrast induced nephropathy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac magnetic resonance; Infarct Size'], 'conditions': ['Myocardial Infarction', 'Percutaneous Coronary Intervention', 'Nicorandil']}, 'referencesModule': {'references': [{'pmid': '16116055', 'type': 'RESULT', 'citation': 'Ishii H, Ichimiya S, Kanashiro M, Amano T, Imai K, Murohara T, Matsubara T. Impact of a single intravenous administration of nicorandil before reperfusion in patients with ST-segment-elevation myocardial infarction. Circulation. 2005 Aug 30;112(9):1284-8. doi: 10.1161/CIRCULATIONAHA.104.530329. Epub 2005 Aug 22.'}, {'pmid': '10080465', 'type': 'RESULT', 'citation': 'Ito H, Taniyama Y, Iwakura K, Nishikawa N, Masuyama T, Kuzuya T, Hori M, Higashino Y, Fujii K, Minamino T. Intravenous nicorandil can preserve microvascular integrity and myocardial viability in patients with reperfused anterior wall myocardial infarction. J Am Coll Cardiol. 1999 Mar;33(3):654-60. doi: 10.1016/s0735-1097(98)00604-4.'}, {'pmid': '17964349', 'type': 'RESULT', 'citation': 'Kitakaze M, Asakura M, Kim J, Shintani Y, Asanuma H, Hamasaki T, Seguchi O, Myoishi M, Minamino T, Ohara T, Nagai Y, Nanto S, Watanabe K, Fukuzawa S, Hirayama A, Nakamura N, Kimura K, Fujii K, Ishihara M, Saito Y, Tomoike H, Kitamura S; J-WIND investigators. Human atrial natriuretic peptide and nicorandil as adjuncts to reperfusion treatment for acute myocardial infarction (J-WIND): two randomised trials. Lancet. 2007 Oct 27;370(9597):1483-93. doi: 10.1016/S0140-6736(07)61634-1.'}, {'pmid': '28279370', 'type': 'RESULT', 'citation': 'Bulluck H, Hammond-Haley M, Weinmann S, Martinez-Macias R, Hausenloy DJ. Myocardial Infarct Size by CMR in Clinical Cardioprotection Studies: Insights From Randomized Controlled Trials. JACC Cardiovasc Imaging. 2017 Mar;10(3):230-240. doi: 10.1016/j.jcmg.2017.01.008.'}, {'pmid': '17478142', 'type': 'RESULT', 'citation': 'Ishii H, Ichimiya S, Kanashiro M, Amano T, Ogawa Y, Mitsuhashi H, Sakai S, Uetani T, Murakami R, Naruse K, Murohara T, Matsubara T. Effect of intravenous nicorandil and preexisting angina pectoris on short- and long-term outcomes in patients with a first ST-segment elevation acute myocardial infarction. Am J Cardiol. 2007 May 1;99(9):1203-7. doi: 10.1016/j.amjcard.2006.12.034. Epub 2007 Mar 16.'}, {'pmid': '11965271', 'type': 'RESULT', 'citation': 'IONA Study Group. Effect of nicorandil on coronary events in patients with stable angina: the Impact Of Nicorandil in Angina (IONA) randomised trial. Lancet. 2002 Apr 13;359(9314):1269-75. doi: 10.1016/S0140-6736(02)08265-X.'}, {'pmid': '11693742', 'type': 'RESULT', 'citation': 'Okamura A, Rakugi H, Ohishi M, Yanagitani Y, Shimizu M, Nishii T, Taniyama Y, Asai T, Takiuchi S, Moriguchi K, Ohkuro M, Komai N, Yamada K, Inamoto N, Otsuka A, Higaki J, Ogihara T. Additive effects of nicorandil on coronary blood flow during continuous administration of nitroglycerin. J Am Coll Cardiol. 2001 Mar 1;37(3):719-25. doi: 10.1016/s0735-1097(00)01171-2.'}, {'pmid': '26012474', 'type': 'RESULT', 'citation': 'Kostic J, Djordjevic-Dikic A, Dobric M, Milasinovic D, Nedeljkovic M, Stojkovic S, Stepanovic J, Tesic M, Trifunovic Z, Zamaklar-Tifunovic D, Radosavljevic-Radovanovic M, Ostojic M, Beleslin B. The effects of nicorandil on microvascular function in patients with ST segment elevation myocardial infarction undergoing primary PCI. Cardiovasc Ultrasound. 2015 May 27;13:26. doi: 10.1186/s12947-015-0020-9.'}, {'pmid': '36073634', 'type': 'DERIVED', 'citation': 'Qian G, Zhang Y, Dong W, Jiang ZC, Li T, Cheng LQ, Zou YT, Jiang XS, Zhou H, A X, Li P, Chen ML, Su X, Tian JW, Shi B, Li ZZ, Wu YQ, Li YJ, Chen YD. Effects of Nicorandil Administration on Infarct Size in Patients With ST-Segment-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: The CHANGE Trial. J Am Heart Assoc. 2022 Sep 20;11(18):e026232. doi: 10.1161/JAHA.122.026232. Epub 2022 Sep 8.'}]}, 'descriptionModule': {'briefSummary': 'We compared the infarct size in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) treated by nicorandil before and after the reperfusion with those standard therapy treated by PCI', 'detailedDescription': 'The aim of this study was to evaluate the efficacy and safety of nicorandil in improving myocardial infarct size in patients with acute myocardial infarction through a multi-center, prospective, randomized, double-blind and parallel-controlled clinical study, providing evidence-based support for the optimization of PCI treatment strategies. The primary objective of the study was to compare whether the effect of nicorandil in combination with PCI was significantly better at reducing the myocardial infarct size than that of PCI alone in AMI patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Acute ST-T elevation MI patients (\\<12h)\n2. undergoing emergency PCI；\n3. Subject has read and signed a written, informed consent form.\n\nExclusion Criteria:\n\n1. SBP\\<80mmHg；\n2. LM stenosis\n3. Aortic dissection；\n4. AMI (\\<6 month)\n5. PCI或CABG (\\<6 month)\n6. Already under the treatment of Nicorandil；\n7. Contraindicated or intolerable to Nicorandil\n8. severe adverse effects to CMR or MRI；\n9. Currently (or within one month) participating in another new drug trial.；\n10. Pregnant or lactation period；\n11. Severe somatic disease preventing the participant from completing the trial, or based on the discretion of the investigators, the patient is incapable of participating; Individuals with abnormal laboratory test results and/or clinical manifestations rendering them unsuitable to participate as judged by the investigators;'}, 'identificationModule': {'nctId': 'NCT03445728', 'briefTitle': 'China-Administration of Nicorandil Group（CHANGE）', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'CHANGE 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'Patients were randomly assigned to two groups before emergent coronary angiography: those who received intravenous (iv.) nicorandil before and after (ivgtt.) reperfusion with PCI (nicorandil group);', 'interventionNames': ['Drug: Nicorandil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'description': 'Patients were randomly assigned to two groups before emergent coronary angiography, those who received placebo before and after reperfusion with PCI.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Nicorandil', 'type': 'DRUG', 'description': 'After randomization, receive primary PCI and standard therapy, 12mg Nicorandil iv. just before ballooning or stenting, then keep Nicorandil 6mg/h ivgtt. up to 24h', 'armGroupLabels': ['Treatment arm']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'After randomization, receive primary PCI and standard therapy, just like the intervension group also iv. just before ballooning or stenting, then keep ivgtt. up to 24h', 'armGroupLabels': ['Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'CHINA', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yundai Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "First People's Hospital of Yulin", 'class': 'OTHER'}, {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, {'name': 'Wuhan Asia Heart Hospital', 'class': 'OTHER'}, {'name': 'Hainan Hospital of PLA General Hospital', 'class': 'UNKNOWN'}, {'name': 'Zunyi Medical College', 'class': 'OTHER'}, {'name': "Guizhou Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, {'name': 'The Second Hospital of Hebei Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yun Dai Chen', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}