Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT03785067
Status:
TERMINATED
Last Update Posted:
2021-04-01
First Post:
2018-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) Cognitive Sub-Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}, {'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000083302', 'term': 'Hemorrhagic Stroke'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D020521', 'term': 'Stroke'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077333', 'term': 'Telmisartan'}, {'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D007190', 'term': 'Indapamide'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007211', 'term': 'Indoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Main Study: Participants are double-blinded. Sub-Study: No blinding to neuropsychological assessments'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Main Study: Multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial.\n\nSub-Study: Multicentre, international, single-arm trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Contractual and financial issues.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2018-12-06', 'studyFirstSubmitQcDate': '2018-12-19', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Memory as measured by the Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associates Learning (PAL) subtest', 'timeFrame': 'Baseline, 18 and 36 months', 'description': 'Raw scores and z-scores will be used. Change scores on the CANTAB PAL will be computed between baseline, 18 and 36 months (primary endpoint).'}], 'secondaryOutcomes': [{'measure': 'Change scores will be computed for CANTAB Rapid Visual Information Processing (RVP)', 'timeFrame': 'Baseline, 18 and 36 months', 'description': 'Change scores will be computed for CANTAB RVP between baseline, 18 and 36 months'}, {'measure': 'Change scores will be computed for CANTAB Multi-tasking Test (MTT)', 'timeFrame': 'Baseline, 18 and 36 months', 'description': 'Change scores will be computed for CANTAB MTT between baseline, 18 and 36 months'}, {'measure': 'Change scores will be computed for gold-standard neuropsychological assessments', 'timeFrame': 'Baseline, 18 and 36 months', 'description': 'Change scores will be computed for gold-standard neuropsychological assessment between baseline, 18 and 36 months'}, {'measure': 'Diagnosis of all-cause dementia', 'timeFrame': '36 months', 'description': 'Diagnosis of all-cause dementia as determined by consensus of three blinded adjudicators based on established criteria following collection of data of the 3-year study period'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TRIDENT'], 'conditions': ['Cognitive Decline', 'Intracerebral Hemorrhage', 'Dementia, Vascular', 'Cerebral Small Vessel Diseases', 'Hypertension', 'Stroke Hemorrhagic']}, 'descriptionModule': {'briefSummary': 'A Sub-Study of an investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial (TRIDENT) to determine the effect of more intensive long-term blood pressure control, provided by a fixed low-dose combination blood pressure lowering pill ("Triple Pill") strategy on top of standard of care, for slowing memory decline as measured by Cambridge Neuropsychological Test Automated Battery (CANTAB), in patients with a history of acute stroke due to intracerebral haemorrhage (ICH).', 'detailedDescription': "Cognitive decline and dementia in ICH is high due to the common underlying vasculopathy of cerebral small vessel disease (CSVD). However, in general, detailed cognitive outcomes in ICH have been neglected, possibly due to the high mortality rate of ICH (up to 60% within the first year).\n\nBlood pressure (BP) management in those with ICH has been suboptimal. Most hypertensive patients need more than two medications. Combination therapy may improve adherence and BP reduction and reduce cardiovascular (CV) event rates. In the main TRIDENT study, it is hypothesised that a fixed low-dose triple combination BP-lowering agent, termed the 'Triple Pill' will prevent recurrent stroke. The Triple Pill is composed of a single capsule containing either a combination of telmisartan 20 mg, amlodipine 2.5 mg and indapamide 1.25 mg, or placebo.\n\nIn addition to achieving optimal BP control, the Triple Pill also has the capacity to slow cognitive decline and dementia in ICH survivors. Research shows that elevated BP is associated with Alzheimer's disease and vascular dementia, even after accounting for prior stroke or transient ischaemic attack, and large scale prospective studies have shown a 50% reduction in dementia when BP is managed appropriately"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Eligible for, randomised and continuing in the TRIDENT Main Study\n2. Must be able to attend the site conducting the cognitive assessments. In Sydney, this will either be at the same site as where TRIDENT study is conducted or at the BMC, University of Sydney, Camperdown.\n3. Ability and willingness to undergo neuropsychological testing (i.e. have no major visual, auditory or motor impairments)\n4. Language spoken compatible with CANTAB administration (i.e. CANTAB will be administered in the local language(s) of the country in question. E.g. in Australia, the CANTAB will only be administered in English).\n5. Provision of written informed consent\n\nExclusion Criteria:\n\n1. Study medication has been permanently stopped prior to or at the 6-month visit of the TRIDENT main study\n2. Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE) score of 3.313 or higher\n3. Cognitive performance indicative of dementia at 6-month TRIDENT main study visit defined by Montreal Cognitive Assessment (MoCA) score less than 2414.\n4. Evidence of rapid deterioration suggestive of dementia by decline of 3 points in MoCA assessments between randomisation and the 6-month study visit in the TRIDENT main study'}, 'identificationModule': {'nctId': 'NCT03785067', 'acronym': 'TRIDENT COG', 'briefTitle': 'Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) Cognitive Sub-Study', 'organization': {'class': 'OTHER', 'fullName': 'The George Institute'}, 'officialTitle': 'Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) Cognitive Sub-Study', 'orgStudyIdInfo': {'id': 'TRIDENT COG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triple Pill (Active Treatment)', 'description': 'Main Study: Fixed low-dose combination BP-lowering pill ("Triple Pill") telmisartan 20mg + amlodipine 2.5mg + indapamide 1.25mg\n\nSub-Study: single-arm', 'interventionNames': ['Drug: telmisartan 20mg + amlodipine 2.5mg +indapamide 1.25mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Main Study: Matched placebo, received via blinded study capsules\n\nSub-Study: single-arm', 'interventionNames': ['Drug: Placebo oral capsule']}], 'interventions': [{'name': 'telmisartan 20mg + amlodipine 2.5mg +indapamide 1.25mg', 'type': 'DRUG', 'otherNames': ['Triple Pill'], 'description': '1 capsule taken orally once daily for 36 months', 'armGroupLabels': ['Triple Pill (Active Treatment)']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': '1 capsule taken orally once daily for 36 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2170', 'city': 'Liverpool', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Liverpool Hospital', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '2050', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '3050', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6525 GC', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Prof Craig Anderson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The George Institute'}, {'name': 'Prof Sharon Naismith', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sydney'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The George Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sydney', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}