Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-02-02 @ 1:45 AM
Study NCT ID:
NCT00321802
Status:
COMPLETED
Last Update Posted:
2015-01-01
First Post:
2006-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-30', 'studyFirstSubmitDate': '2006-05-03', 'studyFirstSubmitQcDate': '2006-05-03', 'lastUpdatePostDateStruct': {'date': '2015-01-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first detected AF', 'timeFrame': '6 Months'}], 'secondaryOutcomes': [{'measure': 'Changes in CRP and oxidative stress levels over time and their relationship with AF burden', 'timeFrame': '6 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'statin therapy', 'CRP levels', 'Paroxysmal Atrial Fibrillation'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of statin therapy for prevention of atrial fibrillation (AF) in pacemaker and non-pacemaker patients with paroxysmal atrial fibrillation in the absence of significant coronary artery disease.', 'detailedDescription': 'Patients with a history of paroxysmal atrial fibrillation, with or without a dual chamber pacemaker and who meet all study criteria, will be randomized to receive either a placebo, or simvastatin 40 mg, daily for 6 months.\n\nLiver enzymes are drawn at randomization and 3 months. CRP and oxidative stress products are drawn at randomization, weekly for the first month and then monthly for 5 months.\n\nPatients transmit their rhythm, twice daily for 5 consecutive days at randomization, then 5 consecutive days monthly for 6 months.\n\nClinic visits are required at randomization, 3 months and 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with paroxysmal AF (\\> 3 epis each \\> 15 min in length) over 6 months\n* Patients on stable antiarrhythmic drug therapy and life expectancy \\> 1 year\n\nExclusion Criteria:\n\n* Patients with PAF due to reversible cause\n* Chronic inflammatory conditions\n* Other medical conditions requiring statin therapy\n* Patients on amiodarone or verapamil\n* Elevated CK or ALT\n* Life expectancy \\<1 year\n* TAVN ablation\n* Geographic isolation\n* Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT00321802', 'acronym': 'PAFRIOSIES', 'briefTitle': 'Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress Injury and Effect of Statins', 'orgStudyIdInfo': {'id': '18108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients randomized to active drug, then AF burden and CRP values will be compared to those in placebo arm.', 'interventionNames': ['Drug: Simvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Patients take placebo once daily for 6 Months, then AF burden and CRP values will be compared to those in experimental arm.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Simvastatin', 'type': 'DRUG', 'otherNames': ['Zocor'], 'description': 'Patients take 40 mg of simvastatin per day for 6 months.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary, Foothills Hospital', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Anne M Gillis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}, {'name': 'Henry J Duff, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Calgary'}, {'name': 'Derek V Exner, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Calgary'}, {'name': 'Katherine Kavanagh, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Calgary'}, {'name': 'L B Mitchell, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Calgary'}, {'name': 'Robert S Sheldon, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Calgary'}, {'name': 'D G Wyse, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Calgary'}, {'name': 'George Veenhuyzen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Calgary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, {'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dr. Anne M. Gillis', 'investigatorAffiliation': 'University of Calgary'}}}}