Condition category
Musculoskeletal Diseases
Date applied
05/02/2002
Date assigned
05/02/2002
Last edited
25/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Maddison

ORCID ID

Contact details

Gwynedd Rheumatology Service
Ysbyty Gwynedd Hospital
Bangor
LL57 2PW
United Kingdom
+44 (0)1248 384 384
peter.maddison@nww-tr.wales.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

M0616

Study information

Scientific title

Acronym

QUINS

Study hypothesis

The objective is to assess the efficacy and tolerability of the Angiotensin-Converting Enzyme (ACE) inhibitor, quinapril, in the management of peripheral vascular manifestations and in preventing progression of visceral organ involvement in patients who fall into the limited cutaneous subset of Systemic Sclerosis (SSc).

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Scleroderma

Intervention

Patients will be randomised to quinapril (20 mg/day) or placebo. The dose will be increased by 20 mg every 2 weeks to a maximum dose of 80 mg/day. Treatment will be for 3 years.

Intervention type

Drug

Phase

Not Specified

Drug names

Quinapril

Primary outcome measures

The rate of occurrence of new ischaemic digital ulcers.

Secondary outcome measures

1. Frequency and severity of Raynaud's phenomenon
2. Introduction of vasodilators
3. Use of measures such as IV Iloprost to treat ischaemic digital lesions
4. Progression of scleroderma skin score
5. Progression of pulmonary and renal disease
6. Occurrence of death, significant macrovascular complications such as stroke and myocardial infarction, and pulmonary hypertension
7. Laboratory measures of endothelial/microvascular injury including von Willebrand factor antigen level, urinary levels of N-Acetyl-Glucosaminidase (NAG) and microalbuminuria

Overall trial start date

01/12/2000

Overall trial end date

30/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 18 years or over, and
1.1. Limited cutaneous Systemic Sclerosis (lcSSc) and Raynaud's phenomenon in which scleroderma is limited to the hands, forearms, face, lower legs and feet, or
1.2. Raynaud's phenomenon and a SSc-specific autoantibody such as anticentromere antibodies, anti-topoisomerase 1, anti-RNApolymerase antibodies, anti-ThRNP antibodies and anti-U3RNP antibodies

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Known allergy to or intolerance of ACE inhibitors
2. Women of childbearing age not using reliable contraception [for example, abstinence, oral or implanted contraception, sexual partner had non-reversed vasectomy, or intra-uterine device (IUD)]
3. History of angioneurotic oedema
4. Significant impairment of renal or hepatic function
5. Severe obstructive valvular heart disease
6. Any other condition that would prevent compliance with treatment or adequate assessment

Recruitment start date

01/12/2000

Recruitment end date

30/11/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gwynedd Rheumatology Service
Bangor
LL57 2PW
United Kingdom

Sponsor information

Organisation

Arthritis Research Campaign (ARC) (UK)

Sponsor details

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
+44 (0)3007 900 400
info@arc.org.uk

Sponsor type

Charity

Website

http://www.arc.org.uk

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2002 protocol in http://www.ncbi.nlm.nih.gov/pubmed/12209028
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17968938

Publication citations

  1. Protocol

    Maddison P, Prevention of vascular damage in scleroderma with angiotensin-converting enzyme (ACE) inhibition., Rheumatology (Oxford), 2002, 41, 9, 965-971.

  2. Results

    Gliddon AE, Doré CJ, Black CM, McHugh N, Moots R, Denton CP, Herrick A, Barnes T, Camilleri J, Chakravarty K, Emery P, Griffiths B, Hopkinson ND, Hickling P, Lanyon P, Laversuch C, Lawson T, Mallya R, Nisar M, Rhys-Dillon C, Sheeran T, Maddison PJ, Prevention of vascular damage in scleroderma and autoimmune Raynaud's phenomenon: a multicenter, randomized, double-blind, placebo-controlled trial of the angiotensin-converting enzyme inhibitor quinapril., Arthritis Rheum., 2007, 56, 11, 3837-3846, doi: 10.1002/art.22965.

Additional files

Editorial Notes