Prevention of vascular damage in scleroderma with angiotensin-converting enzyme inhibition
| ISRCTN | ISRCTN57984704 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57984704 |
| Secondary identifying numbers | M0616 |
- 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
Scientific
Gwynedd Rheumatology Service
Ysbyty Gwynedd Hospital
Bangor
LL57 2PW
United Kingdom
| Phone | +44 (0)1248 384 384 |
|---|---|
| peter.maddison@nww-tr.wales.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Quinapril |
| Primary outcome measure | 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 study start date | 01/12/2000 |
| Completion date | 30/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| 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
LL57 2PW
United Kingdom
Sponsor information
Arthritis Research Campaign (ARC) (UK)
Charity
Charity
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
| Phone | +44 (0)3007 900 400 |
|---|---|
| info@arc.org.uk | |
| Website | http://www.arc.org.uk |
"ROR" |
https://ror.org/02jkpm469 |
Funders
Funder type
Charity
Arthritis Research Campaign (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/09/2002 | Yes | No | |
| Results article | results | 01/11/2007 | Yes | No |
