Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT03073018
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2017-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Renal and Vascular Endstage Disease Intervention Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017328', 'term': 'Fosinopril'}, {'id': 'D017035', 'term': 'Pravastatin'}], 'ancestors': [{'id': 'D010721', 'term': 'Phosphinic Acids'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011392', 'term': 'Proline'}, {'id': 'D007098', 'term': 'Imino Acids'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'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': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 864}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2003-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-07', 'studyFirstSubmitDate': '2017-01-27', 'studyFirstSubmitQcDate': '2017-03-02', 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined incidence of all-cause mortality, MACE and/or end-stage renal disease', 'timeFrame': '4 years', 'description': 'Combined incidence of all-cause mortality or hospital admission for documented (1) non-fatal myocardial infarction, (2) myocardial ischemia, (3) heart failure, (4) peripheral vascular disease, (5) cerebrovascular accident and/or (6) end-stage renal disease'}], 'secondaryOutcomes': [{'measure': 'Incidence of all-cause mortality', 'timeFrame': '4 years', 'description': 'Incidence of all-cause mortality'}, {'measure': 'effect of treatment on microalbuminuria', 'timeFrame': '4 years', 'description': 'albumin excretion mg/24 h'}, {'measure': 'effect of treatment on LDL cholesterol', 'timeFrame': '4 years', 'description': 'in mmol/L'}, {'measure': 'effect of treatment on blood pressure', 'timeFrame': '4 years', 'description': 'in mmHg'}, {'measure': 'Incidence of hospital admission', 'timeFrame': '4 years', 'description': 'Incidence of hospital admission for documented (1) non-fatal myocardial infarction, (2) myocardial ischemia, (3) heart failure, (4) peripheral vascular disease, (5) cerebrovascular accident and/or (6) end-stage renal disease'}]}, 'conditionsModule': {'conditions': ['Microalbuminuria', 'Cardiovascular Diseases', 'Renal Disease']}, 'referencesModule': {'references': [{'pmid': '10980214', 'type': 'BACKGROUND', 'citation': 'Diercks GF, Janssen WM, van Boven AJ, Bak AA, de Jong PE, Crijns HJ, van Gilst WH. Rationale, design, and baseline characteristics of a trial of prevention of cardiovascular and renal disease with fosinopril and pravastatin in nonhypertensive, nonhypercholesterolemic subjects with microalbuminuria (the Prevention of REnal and Vascular ENdstage Disease Intervention Trial [PREVEND IT]). Am J Cardiol. 2000 Sep 15;86(6):635-8. doi: 10.1016/s0002-9149(00)01042-0.'}, {'pmid': '15492322', 'type': 'BACKGROUND', 'citation': 'Asselbergs FW, Diercks GF, Hillege HL, van Boven AJ, Janssen WM, Voors AA, de Zeeuw D, de Jong PE, van Veldhuisen DJ, van Gilst WH; Prevention of Renal and Vascular Endstage Disease Intervention Trial (PREVEND IT) Investigators. Effects of fosinopril and pravastatin on cardiovascular events in subjects with microalbuminuria. Circulation. 2004 Nov 2;110(18):2809-16. doi: 10.1161/01.CIR.0000146378.65439.7A. Epub 2004 Oct 18.'}, {'pmid': '29237679', 'type': 'DERIVED', 'citation': 'Kofink D, Eppinga RN, van Gilst WH, Bakker SJL, Dullaart RPF, van der Harst P, Asselbergs FW. Statin Effects on Metabolic Profiles: Data From the PREVEND IT (Prevention of Renal and Vascular End-stage Disease Intervention Trial). Circ Cardiovasc Genet. 2017 Dec;10(6):e001759. doi: 10.1161/CIRCGENETICS.117.001759.'}]}, 'descriptionModule': {'briefSummary': 'The Prevention of Renal and Vascular Endstage Disease Intervention Trial (PREVEND IT) was designed to determine whether intervention with the angiotensin-converting enzyme (ACE) inhibitor fosinopril and/or the hydroxymethylglutaryl coenzyme A reductase inhibitor pravastatin reduced cardiovascular and renal events in nonhypertensive, nonhypercholesterolemic subjects with microalbuminuria.', 'detailedDescription': 'This study describes the rationale, design, and baseline characteristics of a trial to determine whether treatment with fosinopril 20 mg/day and/or pravastatin 40 mg/ day will prevent cardiovascular and renal disease in nonhypertensive (RR \\<160/100 mm Hg and not using antihypertensive medication) and nonhypercholesterolemic (total cholesterol \\<8.0 or \\<5.0 mmol/L in case of previous myocardial infarction and not using lipid lowering medication) men and women with persistent microalbuminuria (urinary albumin excretion \\>10 mg/L once in an early morning spot urine and 15 to 300 mg/24-hour at least once in two 24-hour urine collections). The Prevention of REnal and Vascular ENdstage Disease Intervention Trial is a single-center, double-blind, randomized, placebo-controlled trial with a 2 x 2 factorial design. The 864 randomized subjects will be monitored for a minimum of 4 years and a maximum of 5 years. The primary efficacy parameter is defined as the combined incidence of all-cause mortality or hospital admission for documented (1) nonfatal myocardial infarction, (2) myocardial ischemia, (3) heart failure, (4) peripheral vascular disease, (5) cerebrovascular accident and/or (6) end-stage renal disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persistent microalbuminuria (urinary albumin excretion \\>10mg/L once in an early morning spot urine and 15 to 300 mg/24 hours at least once in two 24-hour urine samples)\n* No hypertension (RR \\<160/100 mm Hg, no anti-hypertensive medication)\n* No hypercholesterolemia (total cholesterol \\<8.0 or \\<5.0 mmol/L in case of previous myocardial infarction and not using lipid-lowering medication)\n\nExclusion Criteria:\n\n* Creatinine clearance \\>60% of the normal age-adjusted value\n* Serum potassium \\>5.5 mmol/L\n* History of chronic liver disease\n* Lactate dehydrogenase, aspartate-amino transferase or alanine-amino transferase \\>3 times the upper limit of normal\n* Use of angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists\n* Use of insulin\n* Previously documented allergy or intolerance to study drugs\n* Pregnant or nursing women'}, 'identificationModule': {'nctId': 'NCT03073018', 'acronym': 'PREVEND-IT', 'briefTitle': 'Prevention of Renal and Vascular Endstage Disease Intervention Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Prevention of Renal and Vascular Endstage Disease Intervention Trial', 'orgStudyIdInfo': {'id': 'METc 97/10/172'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fosinopril + Pravastatin', 'description': 'Fosinopril (20 mg) + pravastatin (40 mg) once daily for 4 years', 'interventionNames': ['Drug: Fosinopril', 'Drug: Pravastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fosinopril + Placebo', 'description': 'Fosinopril (20 mg) + pravastatin placebo once daily for 4 years', 'interventionNames': ['Drug: Fosinopril', 'Drug: Pravastatin Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pravastatin + Placebo', 'description': 'Pravastatin (40 mg) + fosinopril placebo once daily for 4 years', 'interventionNames': ['Drug: Pravastatin', 'Drug: Fosinopril Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Double Placebo', 'description': 'Fosinopril placebo and pravastatin placebo once daily for 4 years', 'interventionNames': ['Drug: Fosinopril Placebo', 'Drug: Pravastatin Placebo']}], 'interventions': [{'name': 'Fosinopril', 'type': 'DRUG', 'otherNames': ['Monopril'], 'description': 'oral administration, capsules', 'armGroupLabels': ['Fosinopril + Placebo', 'Fosinopril + Pravastatin']}, {'name': 'Pravastatin', 'type': 'DRUG', 'otherNames': ['Pravachol'], 'description': 'oral administration, capsules', 'armGroupLabels': ['Fosinopril + Pravastatin', 'Pravastatin + Placebo']}, {'name': 'Fosinopril Placebo', 'type': 'DRUG', 'description': 'oral administration, capsules', 'armGroupLabels': ['Double Placebo', 'Pravastatin + Placebo']}, {'name': 'Pravastatin Placebo', 'type': 'DRUG', 'description': 'oral administration, capsules', 'armGroupLabels': ['Double Placebo', 'Fosinopril + Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Wiek H van Gilst, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dutch Kidney Foundation', 'class': 'OTHER'}, {'name': 'Netherlands Heart Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prof. Wiek H. van Gilst', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}