Ignite Creation Date:
2025-12-24 @ 1:01 PM
Ignite Modification Date:
2026-01-01 @ 1:12 PM
Study NCT ID:
NCT01091961
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
2010-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Preoperative Management of Angiotensin Converting Enzyme Inhibitor (ACEi) and Angiotensin Receptor Blocker (ARB) Medications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-21', 'studyFirstSubmitDate': '2010-03-22', 'studyFirstSubmitQcDate': '2010-03-23', 'lastUpdatePostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean arterial blood pressure', 'timeFrame': '24 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Clinically significant hypotension', 'timeFrame': '30 days after surgery'}, {'measure': 'Clinically significant hypertension', 'timeFrame': '30 days after surgery'}, {'measure': 'All-cause mortality', 'timeFrame': '30 days after surgery'}, {'measure': 'Cardiovascular morbidity', 'timeFrame': '30 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ACE inhibitor', 'ARB', 'Non-cardiac surgery', 'Perioperative', 'Preoperative', 'Hypotension', 'Congestive heart failure', 'Hypertension', 'Angiotensin-Converting Enzyme Inhibitors', 'Angiotensin II Type 1 Receptor Blockers', 'Perioperative Care'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Patients on a stable dose of ACE inhibitor or ARB medication who are scheduled for elective surgery will be randomized to take their ACE inhibitor or ARB up to and including the morning of surgery, or to hold them a day prior to the surgery. The patients will be followed for 30 days after surgery to assess any adverse health outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* currently taking an ACEi, ARB or both\n* no change in these medications during the two weeks prior to study enrollment\n* scheduled for non-cardiac surgery requiring regional or general anesthesia\n* minimum overnight anticipated length of stay\n* age ≥18 years.\n\nExclusion Criteria:\n\n* explicit instructions provided to patient by surgical team regarding the perioperative management of ACEi or ARB\n* significant hypertension in pre-operative assessment clinic (systolic blood pressure ≥180 mmHg OR diastolic blood pressure ≥110 mmHg)\n* significant hypotension in pre-operative assessment clinic (systolic blood pressure \\< 90 mmHg)\n* prior enrollment in the study\n* participation in another research study of antihypertensive medications'}, 'identificationModule': {'nctId': 'NCT01091961', 'acronym': 'PASS', 'briefTitle': 'Study of Preoperative Management of Angiotensin Converting Enzyme Inhibitor (ACEi) and Angiotensin Receptor Blocker (ARB) Medications', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Pre-Operative Inhibition of the Angiotensin System Study: A Prospective Randomized Single-Blinded Trial of Pre-Operative Management of Medications That Inhibit the Renin-Angiotensin System', 'orgStudyIdInfo': {'id': 'R-09-487'}, 'secondaryIdInfos': [{'id': '16503', 'type': 'OTHER', 'domain': 'REB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuing ACEi/ARB', 'description': 'Patients in this group will continue to take their chronic ACEi/ARB medications up to and including the day of surgery.', 'interventionNames': ['Procedure: Preoperative ACEi/ARB management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Holding ACEi/ARB', 'description': 'Patients in this arm will hold their chronic ACEi/ARB medication at least 24 hours prior to surgery.', 'interventionNames': ['Procedure: Preoperative ACEi/ARB management']}], 'interventions': [{'name': 'Preoperative ACEi/ARB management', 'type': 'PROCEDURE', 'description': 'Patients will either hold their chronic ACEi/ARB medication for at least 24 hours prior to surgery, or continue to take the ACEi/ARB medication up to and including the day of surgery', 'armGroupLabels': ['Continuing ACEi/ARB', 'Holding ACEi/ARB']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Marko Mrkobrada, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Western Ontario, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}