Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT00590135
Status:
TERMINATED
Last Update Posted:
2017-07-26
First Post:
2007-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Effect of Lipitor on Aortic Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Griffib@ccf.org', 'phone': '216-444-6812', 'title': 'Brian Griffin MD', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '24 months', 'eventGroups': [{'id': 'EG000', 'title': 'AORTIC STENOSIS PATIENTS', 'description': 'Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily\n\natorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Aortic Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AORTIC STENOSIS PATIENTS', 'description': 'Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily\n\natorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily'}], 'timeFrame': '2 years', 'description': 'aortic valve area as measured by transthoracic echocardiography was not obtained due to poor reproducibility', 'reportingStatus': 'POSTED', 'populationDescription': 'Population had aortic stenosis, however the primary endpoint of Aortic Valve Area was not obtainable due to poor reproducibility. As a result, the study was terminated.'}, {'type': 'SECONDARY', 'title': 'Rate of Change in the Aortic Valve Area Measured by Transthoracic Echocardiography Compared to That of Historical Controls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AORTIC STENOSIS PATIENTS', 'description': 'Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily\n\natorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily'}], 'timeFrame': '2 years', 'description': 'Rate of change in the aortic valve area measured by transthoracic echocardiography compared to that of historical controls was not obtained. Primary outcome measurement was not obtainable, thus comparison to historic controls was not possible.', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary outcome measurement was not obtainable, thus comparison to historic controls was not possible.'}, {'type': 'SECONDARY', 'title': 'Rate of Change in the Aortic Valve Area Measured by TEE Compared to That of Historical Controls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AORTIC STENOSIS PATIENTS', 'description': 'Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily\n\natorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily'}], 'timeFrame': '2 years', 'description': 'Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in primary measure not being obtained. As the outcome measurement was not obtained, comparison to historical controls was not possible.', 'reportingStatus': 'POSTED', 'populationDescription': 'Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in primary measure not being obtained. As the outcome measurement was not obtained, comparison to historical controls was not possible.'}, {'type': 'SECONDARY', 'title': 'Rate of Change in Aortic Valve Area as Measured by TEE Compared to Standard of Care Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AORTIC STENOSIS PATIENTS', 'description': 'Atorvastatin (Lipitor) 40mg by mouth daily is administered to patients with aortic stenosis\n\natorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily'}], 'timeFrame': '2 years', 'description': 'Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. Thus, comparison to the stand of care group was not possible.', 'reportingStatus': 'POSTED', 'populationDescription': 'Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. Thus, comparison to the stand of care group was not possible.'}, {'type': 'SECONDARY', 'title': 'Change in Mean and Peak Gradients Across the Aortic Valve as Measured by TEE in the Treated Group Compared to Historical Control Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AORTIC STENOSIS PATIENTS', 'description': 'Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily\n\natorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily'}], 'timeFrame': '2 years', 'description': 'Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. This secondary measurement was not obtained as it was deemed not relevant in the absence of the primary outcome measurement and other secondary outcome measurements.', 'reportingStatus': 'POSTED', 'populationDescription': 'Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. This secondary measurement was not obtained as it was deemed not relevant in the absence of the primary outcome measurement and other secondary outcome measurements.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AORTIC STENOSIS PATIENTS', 'description': 'Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily\n\natorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}]}], 'dropWithdraws': [{'type': 'Primary endpoint measure not obtainable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '59'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AORTIC STENOSIS PATIENTS', 'description': 'Patients with mild to moderate calcific aortic stenosis will receive atorvastatin 40 mg by mouth once daily\n\natorvastatin (Lipitor): atorvastatin 40 mg by mouth once daily'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'whyStopped': 'Poor Reducibility - primary endpoint measure not obtainable', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2000-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2010-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2007-12-26', 'resultsFirstSubmitDate': '2017-04-18', 'studyFirstSubmitQcDate': '2008-01-09', 'lastUpdatePostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-25', 'studyFirstPostDateStruct': {'date': '2008-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aortic Stenosis', 'timeFrame': '2 years', 'description': 'aortic valve area as measured by transthoracic echocardiography was not obtained due to poor reproducibility'}], 'secondaryOutcomes': [{'measure': 'Rate of Change in the Aortic Valve Area Measured by Transthoracic Echocardiography Compared to That of Historical Controls', 'timeFrame': '2 years', 'description': 'Rate of change in the aortic valve area measured by transthoracic echocardiography compared to that of historical controls was not obtained. Primary outcome measurement was not obtainable, thus comparison to historic controls was not possible.'}, {'measure': 'Rate of Change in the Aortic Valve Area Measured by TEE Compared to That of Historical Controls', 'timeFrame': '2 years', 'description': 'Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in primary measure not being obtained. As the outcome measurement was not obtained, comparison to historical controls was not possible.'}, {'measure': 'Rate of Change in Aortic Valve Area as Measured by TEE Compared to Standard of Care Group', 'timeFrame': '2 years', 'description': 'Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. Thus, comparison to the stand of care group was not possible.'}, {'measure': 'Change in Mean and Peak Gradients Across the Aortic Valve as Measured by TEE in the Treated Group Compared to Historical Control Group.', 'timeFrame': '2 years', 'description': 'Poor reducibility of aortic valve area measurements with transthoracic echocardiography images resulted in the primary outcome measure not being obtained. This secondary measurement was not obtained as it was deemed not relevant in the absence of the primary outcome measurement and other secondary outcome measurements.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['calcific aortic valve stenosis', 'echocardiography, transthoracic'], 'conditions': ['Aortic Valve Stenosis']}, 'referencesModule': {'references': [{'pmid': '3807436', 'type': 'BACKGROUND', 'citation': 'Passik CS, Ackermann DM, Pluth JR, Edwards WD. Temporal changes in the causes of aortic stenosis: a surgical pathologic study of 646 cases. Mayo Clin Proc. 1987 Feb;62(2):119-23. doi: 10.1016/s0025-6196(12)61880-1.'}, {'pmid': '4098425', 'type': 'BACKGROUND', 'citation': 'Walton KW, Williamson N, Johnson AG. The pathogenesis of atherosclerosis of the mitral and aortic valves. J Pathol. 1970 Jul;101(3):205-20. doi: 10.1002/path.1711010302. No abstract available.'}, {'pmid': '7519131', 'type': 'BACKGROUND', 'citation': "Otto CM, Kuusisto J, Reichenbach DD, Gown AM, O'Brien KD. Characterization of the early lesion of 'degenerative' valvular aortic stenosis. Histological and immunohistochemical studies. Circulation. 1994 Aug;90(2):844-53. doi: 10.1161/01.cir.90.2.844."}, {'pmid': '10047619', 'type': 'BACKGROUND', 'citation': 'Kawaguchi A, Miyatake K, Yutani C, Beppu S, Tsushima M, Yamamura T, Yamamoto A. Characteristic cardiovascular manifestation in homozygous and heterozygous familial hypercholesterolemia. Am Heart J. 1999 Mar;137(3):410-8. doi: 10.1016/s0002-8703(99)70485-0.'}, {'pmid': '8624774', 'type': 'BACKGROUND', 'citation': "O'Brien KD, Reichenbach DD, Marcovina SM, Kuusisto J, Alpers CE, Otto CM. Apolipoproteins B, (a), and E accumulate in the morphologically early lesion of 'degenerative' valvular aortic stenosis. Arterioscler Thromb Vasc Biol. 1996 Apr;16(4):523-32. doi: 10.1161/01.atv.16.4.523."}, {'pmid': '11564401', 'type': 'BACKGROUND', 'citation': 'Chan KL, Ghani M, Woodend K, Burwash IG. Case-controlled study to assess risk factors for aortic stenosis in congenitally bicuspid aortic valve. Am J Cardiol. 2001 Sep 15;88(6):690-3. doi: 10.1016/s0002-9149(01)01820-3. No abstract available.'}, {'pmid': '3812284', 'type': 'BACKGROUND', 'citation': 'Hofmann T, Kasper W, Meinertz T, Spillner G, Schlosser V, Just H. Determination of aortic valve orifice area in aortic valve stenosis by two-dimensional transesophageal echocardiography. Am J Cardiol. 1987 Feb 1;59(4):330-5. doi: 10.1016/0002-9149(87)90808-3.'}, {'pmid': '1951006', 'type': 'BACKGROUND', 'citation': 'Stoddard MF, Arce J, Liddell NE, Peters G, Dillon S, Kupersmith J. Two-dimensional transesophageal echocardiographic determination of aortic valve area in adults with aortic stenosis. Am Heart J. 1991 Nov;122(5):1415-22. doi: 10.1016/0002-8703(91)90585-6.'}, {'pmid': '2918158', 'type': 'BACKGROUND', 'citation': 'Otto CM, Pearlman AS, Gardner CL. Hemodynamic progression of aortic stenosis in adults assessed by Doppler echocardiography. J Am Coll Cardiol. 1989 Mar 1;13(3):545-50. doi: 10.1016/0735-1097(89)90590-1.'}, {'pmid': '2301222', 'type': 'BACKGROUND', 'citation': 'Roger VL, Tajik AJ, Bailey KR, Oh JK, Taylor CL, Seward JB. Progression of aortic stenosis in adults: new appraisal using Doppler echocardiography. Am Heart J. 1990 Feb;119(2 Pt 1):331-8. doi: 10.1016/s0002-8703(05)80024-9.'}, {'pmid': '1626512', 'type': 'BACKGROUND', 'citation': 'Faggiano P, Ghizzoni G, Sorgato A, Sabatini T, Simoncelli U, Gardini A, Rusconi C. Rate of progression of valvular aortic stenosis in adults. Am J Cardiol. 1992 Jul 15;70(2):229-33. doi: 10.1016/0002-9149(92)91280-h.'}, {'pmid': '8404089', 'type': 'BACKGROUND', 'citation': 'Peter M, Hoffmann A, Parker C, Luscher T, Burckhardt D. Progression of aortic stenosis. Role of age and concomitant coronary artery disease. Chest. 1993 Jun;103(6):1715-9. doi: 10.1378/chest.103.6.1715.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if an approved medicine that is used to lower cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve in patients with a condition called aortic stenosis. Patients who have aortic stenosis who volunteer for this study will take Lipitor for 2 years and will undergo a brief exam by a physician, labwork to measure cholesterol, and a routine heart ultrasound (sound picture of the heart) at the start of the study and every 6 months, stopping at 2 years.', 'detailedDescription': 'This is a prospective, single-center study assessing the effect of atorvastatin 40 mg/day (Lipitor, Pfizer) on the progression of calcific aortic stenosis in approximately 70 patients with mild to moderate calcific AS of a tricuspid or bicuspid aortic valve. As a control population, published data on historical AS cohorts will be used, employing the accepted rate of progression of a decrease in aortic valve area of 0.1 cm²/year. Additionally, also for comparison, we will prospectively study a registry of AS patients who meet our entry criteria but are either currently already being treated with or refuse to take an HMG-CoA reductase inhibitor (referred to as the "standard care" group).\n\nAll patient visits, laboratory studies, and echocardiograms will be performed at the Cleveland Clinic Foundation in Cleveland, Ohio with the exception of the 12-week visit ALT measurement which may be done at the patient\'s local doctor\'s office and the results faxed to Imaging Research. The 12-week follow-up assessment may be completed over the phone to establish any change in patient status since baseline, study medication compliance, concomitant medication use and to ascertain whether or not the appropriate laboratory test was obtained. Over a 2-year period, assessments will be conducted at baseline, 6, 12, 18, and 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Mild to moderate calcific AS of a tricuspid or bicuspid aortic valve\n* Echocardiographic derived mean pressure gradient \\>10 mmHg and an aortic valve area of 0.9 to 1.7 cm2 by continuity equation.\n* Laboratory evidence of LDL-c\\>70 mg/dl within 12 months prior to recruitment.\n\nExclusion Criteria:\n\n* Left ventricular ejection fraction \\<50%\n* Valvular area of 0.9 cm2 and a mean gradient \\>30 mmHg\n* Rheumatic heart disease\n* \\>Moderate (2+) aortic insufficiency\n* Prior statin therapy to include: \\>10 mg of atorvastatin (Lipitor) or \\>20 mg of other HMG-CoA Reductase Inhibitors (statins)\n* End-stage renal disease (ESRD)\n* History of thoracic radiation\n* Unable or unwilling to sign informed consent\n* Unable to unwilling to return for follow-up\n* Other clinically important renal, pulmonary, hepatic, neurological, endocrine, or hematological disorders, vasculitis, or any other situation or medical condition that, in the investigator's opinion, would make survival for the duration of the study unlikely, or would otherwise interfere with optimal participation in the study or produce a significant risk to the patient\n* Severe pulmonary hypertension (\\>55 mmHg)"}, 'identificationModule': {'nctId': 'NCT00590135', 'briefTitle': 'The Effect of Lipitor on Aortic Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'The Effect of Statin Therapy (Atorvastatin) on the Progression of Calcific Valvular Aortic Stenosis', 'orgStudyIdInfo': {'id': 'IRB 3516'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AORTIC STENOSIS PATIENTS', 'description': 'Atorvastatin (Lipitor) 40mg by mouth daily is administered to patients with aortic stenosis', 'interventionNames': ['Drug: atorvastatin (Lipitor)']}], 'interventions': [{'name': 'atorvastatin (Lipitor)', 'type': 'DRUG', 'otherNames': ['Lipitor'], 'description': 'atorvastatin 40 mg by mouth once daily', 'armGroupLabels': ['AORTIC STENOSIS PATIENTS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Brian P Griffin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}