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MicroalbuminuriaPhase 3PREVEND-ITNCT03073018

Prevention of Renal and Vascular Endstage Disease Intervention Trial

A Phase 3 study testing Fosinopril and Pravastatin in people with Microalbuminuria and Cardiovascular Diseases, run by University Medical Center Groningen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fosinopril and Pravastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
864 participants
Where
No sites listed yet
Study dates
Apr 1998to Nov 2003
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • No hypertension (RR <160/100 mm Hg, no anti-hypertensive medication)
  • No hypercholesterolemia (total cholesterol <8.0 or <5.0 mmol/L in case of previous myocardial infarction and not using lipid-lowering medication)

Who cannot join

  • Creatinine clearance >60% of the normal age-adjusted value
  • Serum potassium >5.5 mmol/L
  • History of chronic liver disease
  • Lactate dehydrogenase, aspartate-amino transferase or alanine-amino transferase >3 times the upper limit of normal
  • Use of angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists
  • Use of insulin
  • Previously documented allergy or intolerance to study drugs
  • Pregnant or nursing women

About this study

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.

Read the detailed description

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.

Being tested
Fosinopril, Pravastatin, Fosinopril Placebo, Pravastatin Placebo
Medical subject headings
Cardiovascular Diseases, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FosinoprilDrug

    Also called Monopril

    oral administration, capsules

  • PravastatinDrug

    Also called Pravachol

    oral administration, capsules

  • Fosinopril PlaceboDrug

    oral administration, capsules

  • Pravastatin PlaceboDrug

    oral administration, capsules

Study groups in NCT03073018
Study groupRoleWhat they receive
Fosinopril + PravastatinExperimentalFosinopril (20 mg) + pravastatin (40 mg) once daily for 4 years
Receives: Drug: Fosinopril; Drug: Pravastatin
Fosinopril + PlaceboActive comparatorFosinopril (20 mg) + pravastatin placebo once daily for 4 years
Receives: Drug: Fosinopril; Drug: Pravastatin Placebo
Pravastatin + PlaceboActive comparatorPravastatin (40 mg) + fosinopril placebo once daily for 4 years
Receives: Drug: Pravastatin; Drug: Fosinopril Placebo
Double PlaceboPlacebo comparatorFosinopril placebo and pravastatin placebo once daily for 4 years
Receives: Drug: Fosinopril Placebo; Drug: Pravastatin Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined incidence of all-cause mortality, MACE and/or end-stage renal disease

    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

    Measured: 4 years

Secondary outcomes (5)

  1. Incidence of all-cause mortality

    Incidence of all-cause mortality

    Measured: 4 years

  2. effect of treatment on microalbuminuria

    albumin excretion mg/24 h

    Measured: 4 years

  3. effect of treatment on LDL cholesterol

    in mmol/L

    Measured: 4 years

  4. effect of treatment on blood pressure

    in mmHg

    Measured: 4 years

  5. Incidence of hospital admission

    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

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2017
  2. Study startApr 1998
  3. Primary completionJun 2003
  4. Study completionNov 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
864 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03073018
Sponsor's protocol ID
METc 97/10/172
Acronym
PREVEND-IT
Status last verified
Mar 2017
First submitted
27 Jan 2017
Last updated
10 Mar 2017
Results posted
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 10980214

  • 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.

    PubMed 15492322

  • 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.

    PubMed 29237679

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fosinopril and Pravastatin in people with Microalbuminuria and Cardiovascular Diseases, run by University Medical Center Groningen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined incidence of all-cause mortality, MACE and/or end-stage renal disease (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03073018, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.

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