Acute Coronary SyndromePhase 4AVATARNCT01245803
Acute Rosuvastatin for Preventing Myocardial Damage in Patients With ACS
A Phase 4 study testing additional rosuvastatin loading in people with Acute Coronary Syndrome and Angioplasty, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome, Angioplasty
- What is being tested?
- additional rosuvastatin loading
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to May 2011
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 year old
- diagnosed as acute coronary syndrome
- Plan to PCI
Who cannot join
- STEMI patient
- emergency PCI(<2h) for NSTE-ACS
- History of liver disease and myopathy (ALT/AST>3 x upper limit of normal,CK>5 x upper limit of normal)
- TG>500mg/dl,CCr<30ml/min
- inflammatory disease
- allergic to rosuvastatin
- nephrotic syndrome,hypothyroidism,systemic lupus erythematosus,myeloma,et.al.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the 28th division, Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: Acute Rosuvastatin for Preventing Myocardial Damage in Patients With Acute Coronary Syndrome
Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI
- Conditions
- Acute Coronary Syndrome, Angioplasty
- Being tested
- additional rosuvastatin loading, placebo control
- Keywords
- rosuvastatin, angioplasty, acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional rosuvastatin loadingDrug
additional rosuvastatin (10mg p.o.)is given at 18 hours and 4-6 hours before PCI
placebo controlDrug
sugar pill is given 18-24hr and 4-6hr before PCI as control
| Study group | Role | What they receive |
|---|---|---|
| rosuvastatin,one month,lipid lowering | Experimental | additional rosuvastatin(10mg) is given at 18hr and 4-6hr before PCI Receives: Drug: additional rosuvastatin loading |
| sugar pill, one month | Placebo comparator | sugar pill is given 18-24hr and 4-6hr before PCI as control Receives: Drug: placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri-procedural myocardial damage
Measured: 48 hours after PCI
Secondary outcomes (1)
MACE
Measured: 30 days after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245803
- Sponsor's protocol ID
- 6998
- Acronym
- AVATAR
- Status last verified
- Jul 2010
- First submitted
- 22 Nov 2010
- Last updated
- 23 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Rosuvastatin for Preventing Myocardial Damage in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01245803
- Acronym / sponsor ID
- AVATAR / 6998
- Conditions
- Acute Coronary Syndrome, Angioplasty
- Keywords
- rosuvastatin, angioplasty, acute coronary syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 23 Nov 2010 (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.
Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rosuvastatin,one month,lipid lowering | Experimental | Drug: additional rosuvastatin loadingadditional rosuvastatin(10mg) is given at 18hr and 4-6hr before PCI |
| sugar pill, one month | Placebo comparator | Drug: placebo controlsugar pill is given 18-24hr and 4-6hr before PCI as control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-75 year old
- diagnosed as acute coronary syndrome
- Plan to PCI
Key exclusion criteria (7 listed)
- STEMI patient
- emergency PCI(<2h) for NSTE-ACS
- History of liver disease and myopathy (ALT/AST>3 x upper limit of normal,CK>5 x upper limit of normal)
- TG>500mg/dl,CCr<30ml/min
- inflammatory disease
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 |
|---|---|---|
| additional rosuvastatin loadingadditional rosuvastatin (10mg p.o.)is given at 18 hours and 4-6 hours before PCI | Drug | rosuvastatin,one month,lipid lowering |
| placebo controlsugar pill is given 18-24hr and 4-6hr before PCI as control | Drug | sugar pill, one month |
Primary outcome
peri-procedural myocardial damage
Time frame: 48 hours after PCI
1 secondary outcome
MACE
Time frame: 30 days after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2010.
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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.
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 additional rosuvastatin loading in people with Acute Coronary Syndrome and Angioplasty, run by Beijing Anzhen Hospital at 1 site in China.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Nov 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shujjuan Cheng, MD, PhD (+861064456995, chengshujuan1@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peri-procedural myocardial damage (time frame: 48 hours after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2010.