Can Atorvastatin Improve Vascular Function in Women With a History of Preeclampsia?

NCT01278459 | Completed Phase 3

• 1 other identifier: 2008-005759-21
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to test the hypothesis that a short course of atorvastatin can improve vascular function in women with a history of preeclampsia, compared to placebo.

Conditions

Pre-Eclampsia

Keywords

endothelial function; cardiovascular

Outcome Measures

Primary Outcomes (1)

• Alteration in brachial artery flow-mediated dilatation

  After 4 weeks treatment with atorvastatin or placebo

Secondary Outcomes (5)

• Microvascular endothelial function as measured by laser doppler flowmetry

  After 4 weeks treatment with atorvastatin or placebo

• Resistance vessel endothelial function as measured by venous occlusion plethysmography

  After 4 weeks treatment with atorvastatin or placebo

• Indices of arterial stiffness as measured by arterial tonometry and carotid artery distensibility

  After 4 weeks treatment with atorvastatin or placebo

• Plasma biomarkers of inflammation and endothelial function

  After 4 weeks treatment with atorvastatin or placebo

• Endothelial glycocalyx as measured by sublingual Microscan

  After 4 weeks treatment with atorvastatin or placebo

Study Arms (2)

Atorvastatin first

EXPERIMENTAL

Participants receive 4 week treatment with atorvastatin 20mg/day, followed by 4 week washout, followed by 4 week treatment with placebo.

Drug: Atorvastatin

Placebo first

EXPERIMENTAL

Participants receive 4 week treatment with placebo, followed by 4 weeks washout, followed by 4 weeks treatment with atorvastatin 20mg/day.

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

4 week treatment, 20mg/day taken orally in tablet form

Atorvastatin first; Placebo first

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Diagnosed with preeclampsia during index pregnancy: defined as (1) new onset hypertension (\>140/90 mmHg) after 20 weeks gestation and (2) proteinuria (\>0.3g protein/24 hours).
• Participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 4 weeks after.
• Participants must be willing to undertake urine pregnancy test at the start of each 4 week phase of the study to exclude unintended pregnancy.
• Participants must have clinically acceptable laboratory markers of renal, thyroid and hepatic function at enrolment.
• Able (in the Investigator's opinion) and willing to comply with all study requirements.
• Willing to allow her General Practitioner and consultant, if appropriate, to be notified of participation in the study and results of clinical laboratory tests.

You may not qualify if:

• Participants must not be
• Pregnant, lactating during the course of the study.
• Planning pregnancy during course of study or in 4 weeks after study completion
• Taking other medication, whether prescribed or over-the-counter, in the four weeks before first study dose and during the study other than for example mild analgesia or hormonal contraception.
• Taking vitamin medications that may interact with atorvastatin (e.g. niacin, Vitamin D)
• Terminally ill or is inappropriate for placebo medication
• Planning to undertake donation of blood during the study.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford Department of Cardiovascular Medicine

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Paul Leeson, PhD MRCP FESC

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 17, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 1, 2015

Record last verified: 2015-05

Locations

GB (1)