Prevention of vascular damage in scleroderma with angiotensin-converting enzyme inhibition

ISRCTN	ISRCTN57984704
DOI	https://doi.org/10.1186/ISRCTN57984704
Protocol serial number	M0616
Sponsor	Arthritis Research Campaign (ARC) (UK)
Funder	Arthritis Research Campaign (UK)

Submission date: 05/02/2002
Registration date: 05/02/2002
Last edited: 25/11/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Peter Maddison
Scientific

Gwynedd Rheumatology Service
Ysbyty Gwynedd Hospital
Bangor
LL57 2PW
United Kingdom

Phone	+44 (0)1248 384 384
Email	peter.maddison@nww-tr.wales.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	QUINS
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Quinapril
Primary outcome measure(s)	The rate of occurrence of new ischaemic digital ulcers.
Key secondary outcome measure(s)	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
Completion date	30/11/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Lower age limit	18 Years
Sex	Not Specified
Key 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
Key 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
Date of first enrolment	01/12/2000
Date of final enrolment	30/11/2006

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Gwynedd Rheumatology Service

Bangor
LL57 2PW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2007		Yes	No
Protocol article	protocol	01/09/2002		Yes	No