Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT00294567
Status:
COMPLETED
Last Update Posted:
2021-05-14
First Post:
2006-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Azelnidipine Anti-Coronary Atherosclerotic Trial in Hypertensive Patients by Serial Volumetric IVUS Analysis(ALPS-J)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D058225', 'term': 'Plaque, Amyloid'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002121', 'term': 'Calcium Channel Blockers'}, {'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'C061679', 'term': 'azelnidipine'}], 'ancestors': [{'id': 'D049990', 'term': 'Membrane Transport Modulators'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000077264', 'term': 'Calcium-Regulating Hormones and Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-12', 'studyFirstSubmitDate': '2006-02-20', 'studyFirstSubmitQcDate': '2006-02-21', 'lastUpdatePostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in plaque volume from the baseline value. (IVUS) Percent change in plaque volume = (plaque volume after 48 weeks of drug administration - baseline plaque volume) / baseline plaque volume', 'timeFrame': '48Weeks'}], 'secondaryOutcomes': [{'measure': 'Change of plaque volume from the baseline value. (IVUS) Amount change and percent change in Minimal lumen diameter and % stenosis. (Quantitative Coronary Analysis) Change of intimal thickening volume in-stent.', 'timeFrame': '48Weeks'}, {'measure': 'Correlativity of plaque volume and inflammatory laboratory parameters (hs-CRP, MCP-1, PTX-3) Correlativity of laboratory parameters and blood pressure. Correlativity of plaque volume and antioxidant laboratory parameters (LPO, 8-isoprostane)', 'timeFrame': '48Weeks'}, {'measure': 'The following treatments and incidence of events, Changes from baseline of laboratory parameters (TC, LDL-C,TG, HDL-C, hs-CRP, MCP-1, LPO, 8-isoprostane, PTX-3) after 48 weeks of drug administration. Correlativity of plaque volume and blood pressure.', 'timeFrame': '48Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'PCI', 'Calcium Channel Blockers', 'IVUS', 'Plaque'], 'conditions': ['Hypertension', 'Coronary Atherosclerosis']}, 'referencesModule': {'references': [{'pmid': '23214115', 'type': 'DERIVED', 'citation': 'Miyauchi K, Daida H. [Azelnidipine and amlodipine anti-coronary atherosclerosis trial in hypertensive patients undergoing coronary intervention by serial volumetric intravascular ultrasound analysis in Juntendo Medical University]. Nihon Naika Gakkai Zasshi. 2012 Oct 10;101(10):3002-11. doi: 10.2169/naika.101.3002. No abstract available. Japanese.'}, {'pmid': '21471671', 'type': 'DERIVED', 'citation': 'Kojima T, Miyauchi K, Yokoyama T, Yokoyama K, Kurata T, Suwa S, Kawamura M, Tamura H, Okazaki S, Inoue K, Fujiwara Y, Sumiyoshi M, Tanimoto K, Nakazato Y, Yamagami S, Hiro T, Komiyama N, Daida H. Azelnidipine and amlodipine anti-coronary atherosclerosis trial in hypertensive patients undergoing coronary intervention by serial volumetric intravascular ultrasound analysis in Juntendo University (ALPS-J). Circ J. 2011;75(5):1071-9. doi: 10.1253/circj.cj-11-0141. Epub 2011 Apr 7.'}]}, 'descriptionModule': {'briefSummary': 'In patients with hypertension who undergo elective PCI, the effects of long-term administration of Calblock (azelnidipine) on plaque volume will be determined quantitatively by 3D-IVUS and compared with those of amlodipine besilate (Norvasc or Amlodin).', 'detailedDescription': 'Clinical studies have demonstrated that calcium antagonists can reduce cardiovascular events in patients with coronary artery disease. Recently, suppression of the development of coronary atherosclerotic plaque by calcium antagonists has been reported as one of the mechanisms involved. Thus, calcium antagonists have been promising strategy for preventing the progression of the coronary atherosclerosis. Various calcium antagonists are clinically available at present and these drugs may differ from each other with respect to the anti-atherosclerotic effects. Consequently, we plan to perform the ALPS-J study to compare the effects of two long-acting calcium antagonists, azelnidipine and amlodipine, on plaque quantitatively by IVUS. In this study, azelnidipine (16 mg/day) or amlodipine besilate (5 mg/day) will be administered to patients with hypertension for 48 weeks after elective PCI. The plaque volume will be measured in each patient by IVUS at the time of PCI and 48 weeks after PCI. Percent change in plaque volume from the baseline value will be used as the primary endpoints for evaluation of efficacy. We plan to enroll 100 patients in each group for a total of 200 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: Between 20 and 79 years (at the time of giving informed consent).\n* Sex: Either sex.\n* Admission status: Outpatients.\n* Patients requiring treatment for hypertension according to the JSH 2004 hypertension therapy guidelines before beginning this study\n* Patients who have not used any calcium antagonists for at least 4 weeks before the beginning of this study.\n* Patients who are scheduled to undergo elective PCI.\n\nExclusion Criteria:\n\n* Patients with acute coronary syndrome (ACS).\n* Patients who have experienced Q-wave myocardial infarction within 4 weeks before beginning this study.\n* Patients with renal dysfunction (serum creatinine \\>2.0 mg/dL).\n* Patients in whom PCI is unsuccessful.\n* Patients with cardiogenic shock.\n* Patients with moderate or severe congestive heart failure.\n* Patients with 50% or more stenosis of the main trunk of the left coronary artery.\n* Patients with other problems whom the investigator considers unsuitable for this study.'}, 'identificationModule': {'nctId': 'NCT00294567', 'briefTitle': 'Azelnidipine Anti-Coronary Atherosclerotic Trial in Hypertensive Patients by Serial Volumetric IVUS Analysis(ALPS-J)', 'organization': {'class': 'OTHER', 'fullName': 'Juntendo University'}, 'officialTitle': 'Azelnidipine and Amlodipine Anti-Coronary Atherosclerotic Trial in Hypertensive Patients Undergoing Coronary Intervention by Serial Volumetric Intravascular Ultrasound Analysis in Junten Medical University (ALPS-J)', 'orgStudyIdInfo': {'id': 'JHF-17NOV2005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Amlodipine', 'interventionNames': ['Drug: Calcium channel blockers (amlodipine, azelnidipine)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Azelnidipine', 'interventionNames': ['Drug: Calcium channel blockers (amlodipine, azelnidipine)']}], 'interventions': [{'name': 'Calcium channel blockers (amlodipine, azelnidipine)', 'type': 'DRUG', 'description': 'Drug: amlodipine Drug: azelnidipine', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Department of Cardiology, Juntendo University School of Medicine', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'HIROYUKI MD DAIDA', 'role': 'STUDY_CHAIR', 'affiliation': 'Director of Cardiology Professor of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Juntendo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Japan Heart Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}