AtherosclerosisPhase 4NCT00371501
Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus
A Phase 4 study testing Rosuvastatin and aspirin in people with Atherosclerosis and Thromboembolism, run by Tuen Mun Hospital at 1 site in Hong Kong.
Trial summary
The purpose of this trial is to study if aspirin and statins (lipid-lowering agents) can reduce the progression of subclinical atherosclerosis in patients with systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Thromboembolism, Systemic Lupus Erythematosus
- What is being tested?
- Rosuvastatin and aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2006to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Fulfillment of at least 4 of the American College of Rheumatology (ACR) criteria for SLE
- Presence of any two of the following risk factors:
- SLE duration of >= 5 years
- Postmenopausal
- Age >= 40 years
Show all 15Show fewer
- Diabetes mellitus
- Hypertension (140/90 mmHg)
- Serum low density lipoprotein (LDL) level >= 2.6 mmol/L or total cholesterol >= 5.5 mmol/L
- Obesity (body mass index >= 27 kg/m2)
- Chronic current smoker
- Positive antiphospholipid antibodies
- Renal function impairment
- Persistent proteinuria >= 1 gm/day for >= 6 months
- Informed consent obtained
Who cannot join
- Patients with known allergy to aspirin, or any other non-steroidal anti-inflammatory drugs (NSAIDs), or statins
- Patient with a history of severe gastrointestinal intolerance to aspirin (e.g., gastrointestinal bleeding) or other NSAIDs
- Patients with history of arterial or venous thromboembolism
- Patients receiving aspirin or other anti-platelet agents
- Patients receiving long-term non-aspirin NSAIDs
- Patients receiving anticoagulation therapy (e.g., warfarin)
- Patients with history of intolerance or allergy to the statins
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Dose Aspirin and Statins for Primary Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus: A Randomized Double-blind Placebo-controlled Trial
The purpose of this trial is to study if aspirin and statins (lipid-lowering agents) can reduce the progression of subclinical atherosclerosis in patients with systemic lupus erythematosus (SLE).
Read the detailed description
To study if aspirin and statins (lipid-lowering agents) can reduce the progression of subclinical atherosclerosis in patients with systemic lupus erythematosus. Subclinical atherosclerosis is assessed by ultrasound study of the carotid vessels and CT scan of the coronary arteries for calcium scores. Blood markers of endothelial activation will also be studied.
- Being tested
- Rosuvastatin, placebo, aspirin
- Keywords
- lupus, atherosclerosis, thrombosis, statin, lipid
- Medical subject headings
- Atherosclerosis, Thromboembolism, Lupus Erythematosus, Systemic, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
10mg/day
placeboDrug
one tablet/day
aspirinDrug
80mg/day
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| treatment arm 1 | Active comparator | Not described Receives: Drug: Rosuvastatin |
| Treatment arm 2 | Placebo comparator | Not described Receives: Drug: placebo |
| treatment arm 3 | Active comparator | aspirin Receives: Drug: aspirin |
| treatment arm 4 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial activation markers
Measured: 12 months
Secondary outcomes (4)
carotid intima media thickness
Measured: 24 months
coronary Agatston score
Measured: 60 months
Thrombotic events
Measured: 60 months
adverse events
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuen Mun Hospital
- Sponsor type
- Other government
- Collaborators
- AstraZeneca
- Investigators
- CC Mok, MD, FRCP, Principal investigator, Department of Medicine, Tuen Mun Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371501
- Sponsor's protocol ID
- HARECCTR0500059
- Status last verified
- Sep 2010
- First submitted
- 1 Sep 2006
- Last updated
- 16 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mok CC, Wong CK, To CH, Lai JP, Lam CS. Effects of rosuvastatin on vascular biomarkers and carotid atherosclerosis in lupus: a randomized, double-blind, placebo-controlled trial. Arthritis Care Res (Hoboken). 2011 Jun;63(6):875-83. doi: 10.1002/acr.20440.
PubMed 21309005
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Aspirin and Statins for Primary Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus: A Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00371501
- Acronym / sponsor ID
- HARECCTR0500059
- Keywords
- lupus, atherosclerosis, thrombosis, statin, lipid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Tuen Mun HospitalOther government
- Collaborators
- AstraZeneca
- Study start
- Jun 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to study if aspirin and statins (lipid-lowering agents) can reduce the progression of subclinical atherosclerosis in patients with systemic lupus erythematosus (SLE).
Detailed description
To study if aspirin and statins (lipid-lowering agents) can reduce the progression of subclinical atherosclerosis in patients with systemic lupus erythematosus. Subclinical atherosclerosis is assessed by ultrasound study of the carotid vessels and CT scan of the coronary arteries for calcium scores. Blood markers of endothelial activation will also be studied.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| treatment arm 1 | Active comparator | Drug: Rosuvastatin |
| Treatment arm 2 | Placebo comparator | Drug: placebo |
| treatment arm 3 | Active comparator | Drug: aspirinaspirin |
| treatment arm 4 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age > 18 years
- Fulfillment of at least 4 of the American College of Rheumatology (ACR) criteria for SLE
- Presence of any two of the following risk factors:
- Informed consent obtained
Key exclusion criteria (8 listed)
- Patients with known allergy to aspirin, or any other non-steroidal anti-inflammatory drugs (NSAIDs), or statins
- Patient with a history of severe gastrointestinal intolerance to aspirin (e.g., gastrointestinal bleeding) or other NSAIDs
- Patients with history of arterial or venous thromboembolism
- Patients receiving aspirin or other anti-platelet agents
- Patients receiving long-term non-aspirin NSAIDs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAlso: Crestor10mg/day | Drug | treatment arm 1 |
| placeboone tablet/day | Drug | Treatment arm 2 |
| aspirin80mg/day | Drug | treatment arm 3 |
| placeboplacebo | Drug | treatment arm 4 |
Primary outcome
endothelial activation markers
Time frame: 12 months
4 secondary outcomes
carotid intima media thickness
Time frame: 24 months
coronary Agatston score
Time frame: 60 months
Thrombotic events
Time frame: 60 months
adverse events
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2010.
- Derived from this study: PubMed 21309005Mok CC, Wong CK, To CH, Lai JP, Lam CS. Effects of rosuvastatin on vascular biomarkers and carotid atherosclerosis in lupus: a randomized, double-blind, placebo-controlled trial. Arthritis Care Res (Hoboken). 2011 Jun;63(6):875-83. doi: 10.1002/acr.20440.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CC Mok, MD, FRCP principal investigator
Department of Medicine, Tuen Mun Hospital, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin and aspirin in people with Atherosclerosis and Thromboembolism, run by Tuen Mun Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endothelial activation markers (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00371501, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2010.