NCT00423280

Brief Summary

The purpose of this study is to determine the effect of 6R-BH4 on vascular function in patients with coronary artery disease. We hypothesize that 6R-BH4 will improve vascular function in these patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for phase_2 coronary-artery-disease

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 18, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

August 7, 2008

Status Verified

June 1, 2008

Enrollment Period

2.3 years

First QC Date

January 17, 2007

Last Update Submit

August 6, 2008

Conditions

Coronary Artery Disease

Keywords

EndotheliumNitric OxideMagnetic Resonance ImagingTetrahydrobiopterin

Outcome Measures

Primary Outcomes (1)

  • Vascular function using non-invasive magnetic resonance imaging (MRI).

    Pre- and post- treatment with 6R-BH4 or placebo

Secondary Outcomes (1)

  • Laboratory measures of vascular function.

    At time of CABG surgery

Study Arms (3)

1

ACTIVE COMPARATOR

700mg/day 6R-BH4

Drug: 6R-BH4

2

ACTIVE COMPARATOR

400mg/day 6R-BH4

Drug: 6R-BH4

3

PLACEBO COMPARATOR

Placebo

Drug: 6R-BH4

Interventions

6R-BH4DRUG

6R-BH4 tablets 700mg/day, 6R-BH4 tablets 400mg/day or placebo

Also known as: Sapropterin dihydrochloride
123

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Multi-vessel coronary artery disease scheduled for coronary artery bypass surgery (CABG)

You may not qualify if:

  • Inability to provide informed consent
  • Female subject who is pregnant, lactating or planning pregnancy during course of study
  • Prior clinical diagnosis of heart failure requiring diuretic therapy with evidence of severe left ventricular dysfunction
  • Recent acute coronary event (\<4 weeks)
  • Emergency CABG
  • Newly diagnosed diabetes mellitus (\<1 month)
  • Body weight \>130kg
  • Impaired renal function (creatinine \>180umol/l)
  • Elevated liver function tests (ALT \>50umol/l or AST \>2x normal)
  • Pacemakers, ICDs or metallic implants not compatible with MRI scanning
  • Subjects receiving experimental medications or participating in another study
  • Terminally ill subjects
  • Known hypersensitivity to 6R-BH4
  • Concomitant treatment with methotrexate, levodopa, PDE-3 or PDE-5 inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiovascular Medicine, University of Oxford

Oxford, OX3 9DU, United Kingdom

RECRUITING

Related Publications (2)

  • Cunnington C, Van Assche T, Shirodaria C, Kylintireas I, Lindsay AC, Lee JM, Antoniades C, Margaritis M, Lee R, Cerrato R, Crabtree MJ, Francis JM, Sayeed R, Ratnatunga C, Pillai R, Choudhury RP, Neubauer S, Channon KM. Systemic and vascular oxidation limits the efficacy of oral tetrahydrobiopterin treatment in patients with coronary artery disease. Circulation. 2012 Mar 20;125(11):1356-66. doi: 10.1161/CIRCULATIONAHA.111.038919. Epub 2012 Feb 7.

    PMID: 22315282DERIVED

  • Cunnington C, Channon KM. Tetrahydrobiopterin: pleiotropic roles in cardiovascular pathophysiology. Heart. 2010 Dec;96(23):1872-7. doi: 10.1136/hrt.2009.180430. Epub 2010 Sep 13.

    PMID: 20837663DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

sapropterin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Keith M Channon, MD FRCP

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Colin Cunnington, MBChB MRCP

CONTACT

+44-1865-221866colin.cunnington@cardiov.ox.ac.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 17, 2007

First Posted

January 18, 2007

Study Start

November 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

August 7, 2008

Record last verified: 2008-06

Locations

GB(1)