Myocardial InfarctionPhase 4PCINCT01372839
Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome
A Phase 4 study testing Atorvastatin and Statin in people with Myocardial Infarction and Unstable Angina, run by Xijing Hospital at 1 site in China.
Trial summary
Compare with regular regimen, the aim of this study is to testify whether having more statin during PCI will benefit in Chinese population, and to find out optimal dose of the drug for patient after PCI. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Infarction, Unstable Angina
- What is being tested?
- Atorvastatin and Statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Jul 2012
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-85 years old
- Patients with clinical diagnosis of ACS
- Evidence of a personally signed and dated informed consent document
Who cannot join
- Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment.
- LDL-C < 1.8mmol/L in patients without statin therapy in 1 months
- Endstage congestive heart failure, or LVEF < 30%
- Active hepatic disease or hepatic dysfunction, or AST/ALT > 1.5UNL
- Myopathy or increased creatine kinase (CK>2 UNL)
- Severe renal dysfunction(Scr > 3 mg/dl or 264μmol/L)
Show all 12Show fewer
- Allergic or experienced serious adverse reaction to HMG-CoA reductase, or ineligible to take statin as investigator's judgment
- Severe aortic valve stenosis or severe mitral stenosis, Obstructive hypertrophic cardiomyopathy, pericardial diseases
- Pregnancy, lactation, or child bearing potential women without any effective contraception
- Accompanied with malignant disease or other disease, which cause life expectancy < 6 months
- Participating in other interventional clinical trails using drugs or devices
- Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Ling Tao, M.D Ph.D, +86-15002955798, lingtao2006@gmail.com
Ling Tao, M.D Ph.D
About this study
Official title: The Safety and Efficacy of Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome
Compare with regular regimen, the aim of this study is to testify whether having more statin during PCI will benefit in Chinese population, and to find out optimal dose of the drug for patient after PCI.
Read the detailed description
This study is designed to find out whether patients undergoing PCI can benefit from intensive atorvastatin treatment compared with routine treatment on chinese population.
- Conditions
- Myocardial Infarction, Unstable Angina
- Being tested
- Atorvastatin, Statin
- Keywords
- Myocardial Infarction, Unstable Angina
- Medical subject headings
- Myocardial Infarction, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
StatinDrug
Usual care, but statin dose should not be higher than that described in exclusion criteria
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Active comparator | 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care Receives: Drug: Atorvastatin |
| Usual care | Other | statin dose should not be higher than that described in exclusion criteria. Receives: Drug: Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI
Measured: 30-day
Secondary outcomes (6)
Post-procedural change of inflammatory biomarkers (hs-CRP)
Measured: 24h
Morbidity of CIN
Measured: 48h
Elevation of ALT, AST and CK
Proportion of patients who experience at least once AST>3UNL，ALT>3UNL or CK>5UNL after initiation of study treatment. Proportion of patients who experience at least once AST, ALT, or CK>UNL after initiation of study treatment.
Measured: 6 months
Number of Participants with Adverse Events
Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events
Measured: 6 months
Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events
Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.
Measured: 6 months
serum adiponectin concentration
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startJul 2010
- Primary completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Xijing 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
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yong Huo, MD, Study director, Division of Cardiology, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372839
- Sponsor's protocol ID
- xj050511
- Acronym
- PCI
- Status last verified
- Jul 2010
- First submitted
- 10 Jun 2011
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01372839
- Acronym / sponsor ID
- PCI / xj050511
- Conditions
- Myocardial Infarction, Unstable Angina
- Keywords
- Myocardial Infarction, Unstable Angina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (estimated)
- First posted
- 14 Jun 2011 (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.
Compare with regular regimen, the aim of this study is to testify whether having more statin during PCI will benefit in Chinese population, and to find out optimal dose of the drug for patient after PCI.
Detailed description
This study is designed to find out whether patients undergoing PCI can benefit from intensive atorvastatin treatment compared with routine treatment on chinese population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Active comparator | Drug: Atorvastatin80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care |
| Usual care | Other | Drug: Statinstatin dose should not be higher than that described in exclusion criteria. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-85 years old
- Patients with clinical diagnosis of ACS
- Evidence of a personally signed and dated informed consent document
Key exclusion criteria (12 listed)
- Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment.
- LDL-C < 1.8mmol/L in patients without statin therapy in 1 months
- Endstage congestive heart failure, or LVEF < 30%
- Active hepatic disease or hepatic dysfunction, or AST/ALT > 1.5UNL
- Myopathy or increased creatine kinase (CK>2 UNL)
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 |
|---|---|---|
| AtorvastatinAtorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care | Drug | Atorvastatin |
| StatinUsual care, but statin dose should not be higher than that described in exclusion criteria | Drug | Usual care |
Primary outcome
30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI
Time frame: 30-day
6 secondary outcomes
Post-procedural change of inflammatory biomarkers (hs-CRP)
Time frame: 24h
Morbidity of CIN
Time frame: 48h
Elevation of ALT, AST and CK
Time frame: 6 months
Number of Participants with Adverse Events
Time frame: 6 months
Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events
Time frame: 6 months
serum adiponectin concentration
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
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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.
Yong Huo, MD study director
Division of Cardiology, Peking University First Hospital
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 Atorvastatin and Statin in people with Myocardial Infarction and Unstable Angina, run by Xijing 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 12 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 14 Jun 2011. 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. 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 Ling Tao, M.D Ph.D (+86-15002955798, lingtao2006@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI (time frame: 30-day). 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 14 Jun 2011.