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ISRCTN
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ISRCTN57984704
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ClinicalTrials.gov identifier
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Public title
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Prevention of vascular damage in scleroderma with angiotensin-converting enzyme inhibition
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Scientific title
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Acronym
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QUINS
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Serial number at source
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M0616
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Study hypothesis
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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).
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Scleroderma
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/12/2000
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Anticipated end date
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30/11/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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.
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Primary outcome measure(s)
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The rate of occurrence of new ischaemic digital ulcers.
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Secondary outcome measure(s)
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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
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Sources of funding
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Arthritis Research Campaign (UK)
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Trial website
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Publications
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Protocol in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=12209028
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17968938
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Contact name
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Professor
Peter
Maddison
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Address
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Gwynedd Rheumatology Service
Ysbyty Gwynedd Hospital
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City/town
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Bangor Clwyd & Gwynedd
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Zip/Postcode
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LL57 2PW
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Country
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United Kingdom
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Email
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peter.maddison@nww-tr.wales.nhs.uk
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Sponsor
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Arthritis Research Campaign (ARC) (UK)
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Address
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Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
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City/town
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Derbyshire
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Zip/Postcode
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S41 7TD
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Country
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United Kingdom
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Email
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info@arc.org.uk
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Sponsor website:
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http://www.arc.org.uk
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Date applied
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05/02/2002
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Last edited
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07/12/2007
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Date ISRCTN assigned
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05/02/2002
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