PCI PatientsNCT02561845
Effectiveness of Statins on Lipid Goal Attainment and Lipid Parameters in PCI Patients
An observational study of PCI Patients, run by AstraZeneca.
Trial summary
Most PCI patients are at very high cardiovascular (CV) risk, and as such here is an increased need for intensive lipid management in Percutaneous Coronary Intervention (PCI) patients and the population is well suited to demonstrating rosuvastatin's low density lipoprotein-cholesterol (LDL-C) lowering efficacy.Most PCI… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- PCI Patients
- What is being tested?
- rosuvastatin
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Oct 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: PCI Patients initiating statin therapy
Who may be able to join
- Patients must have had at least one treatment for statins, during the intake period (between 01/07/2011 and 31/01/2015). The date treated with statins after hospitalization before PCI or after PCI for statin naive patients, and date of PCI procedure for statin users will be marked as an index date.
- Patients must be 18 years or older at the time of index date.
- Patients must have at least 1 month of follow-up after the index date, including continuous statin treatment, lipid profile and lab values for safety profile.
- Patients must have at least two lab values: one full lipid panel prior to or on the index date, and one at least 30 days following the index date.
Who cannot join
- Patients with a diagnosis of Familial Hypercholesterolemia.
- Patients with malignant tumor at the index day.
About this study
Official title: Effectiveness of Statins on Lipid Goal Attainment and Lipid Parameters in Percutaneous Coronary Intervention Patients
Most PCI patients are at very high cardiovascular (CV) risk, and as such here is an increased need for intensive lipid management in Percutaneous Coronary Intervention (PCI) patients and the population is well suited to demonstrating rosuvastatin's low density lipoprotein-cholesterol (LDL-C) lowering efficacy.Most PCI patients are at very high CV risk, and as such here is an increased need for intensive lipid management in PCI patients and the population is well suited to demonstrating rosuvastatin's LDL-C lowering efficacy.The purpose of this study is to observe the effectiveness of statins on lipid level reduction (LDL-C, high density lipoprotein-cholesterol (HDL-C), Triglyceride (TG), and non-HDL-C) and lipid goal attainment according to recent guidelines.
Read the detailed description
The number of patients receiving Percutaneous Coronary Intervention (PCI) is rapidly increasing in China. In 2013, about 450,000 Chinese patients received PCI, most of whom suffered from coronary heart disease (CHD), especially acute coronary syndrome (ACS). ACS is associated with an increased risk of cardiovascular mortality and recurrent cardiac events, underscoring the importance of identifying treatments that minimize this risk.The Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) trial suggested a benefit of lipid lowering with high-dose atorvastatin in patients with ACS. A meta-analysis of statin use in patients with ACS confirmed the benefits of early high-dose statin administration in decreasing recurrent myocardial ischemia, which suggested the clinical benefit and safety of statins were dose and statin dependent. The updated National Cholesterol Education Program Adult Treatment Panel III guidelines recommend that intensive therapy should be considered for all patients admitted to hospital for an ACS. Two meta-analyses have shown that early intensive statin therapy in patients with ACS is associated with a reduced rate of death and cardiovascular events. In the PROVE IT study, comparing atorvastatin 80 mg with pravastatin 40 mg, a significant reduction in major adverse clinical events was observed in favour of more intensive statin treatment. In that study, the median concentration of low-density LDL-C was lowered from 106 mg/dL to 62 mg/dL in the atorvastatin 80 mg group. More recently, the 2011 European Society of Cardiology (ESC)/ European Arterial Sclerosis Association (EAS) guideline for the management of dyslipidemia recommended patients with ACS are very high CV risk patients and should achieve LDL-C level <70 mg/dl or 50% reduction. In 2011 American College of Cardiology Foundation (ACCF) / American Heart Association (AHA) / (cardiovascular angiography and intervention Association)/ Association of Cardiovascular angiography and intervention (SCAI) Guideline for PCI, statin therapy which lowers LDL to <70mg/dL in very high-risk patients is recommended (IIa, B). The latest China ACS consensus also recommends using the highest dose statin treatment for the acute phase and to attain an LDL-C level of 1.8 mmol/L or 50% reduction compared with baseline in long-term treatment. However, there are very limited Chinese data demonstrating the current situation of lipid management (LDL-C on-goal rate) by different statins in real-world clinical practice.
Most PCI patients are at very high CV risk, and as such here is an increased need for intensive lipid management in PCI patients and the population is well suited to demonstrating rosuvastatin's LDL-C lowering efficacy.Most PCI patients are at very high CV risk, and as such here is an increased need for intensive lipid management in PCI patients and the population is well suited to demonstrating rosuvastatin's LDL-C lowering efficacy.The purpose of this study is to observe the effectiveness of statins on lipid level reduction (LDL-C, HDL-C, TG, and non-HDL-C) and lipid goal attainment according to recent guidelines.
- Conditions
- PCI Patients
- Being tested
- rosuvastatin
- Keywords
- Effectiveness of statins, on lipid goal attainment and lipid parameters in Percutaneous Coronary Intervention patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosuvastatinDrug
5mg, 10mg, 20mg
| Study group | Role | What they receive |
|---|---|---|
| rosuvastatin group | patients who received rosuvastatin Receives: Drug: rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Low density lipoprotein-cholesterol (LDL-C) at 30 days
by assessment of statins on the on-goal rate of LDL-C treatment of patients underwent PCI
Measured: Blood samples are collected pre-dose, 30 days post dose
Secondary outcomes (9)
Change from baseline lipid level at 30 days
by assessment of other lipid level reduction from baseline lab value to the last lab value
Measured: Blood samples are collected pre-dose, 30 days post dose
Change from baseline lipid level at 3 months
by assessment of other lipid level reduction from baseline lab value to the last lab value
Measured: Blood samples are collected pre-dose, 3 months post dose
Change from baseline lipid level at 6 months
by assessment of other lipid level reduction from baseline lab value to the last lab value
Measured: Blood samples are collected pre-dose, 6 months post dose
Change from baseline lipid level at 12 months
by assessment of other lipid level reduction from baseline lab value to the last lab value
Measured: Blood samples are collected pre-dose, 12 months post dose
number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 30 days
by assessment of safety profile
Measured: Blood samples are collected at 30 days post dose
number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 3 months
by assessment of safety profile
Measured: Blood samples are collected at 3 months post dose
number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 6 months
by assessment of safety profile
Measured: Blood samples are collected at 6 months post dose
number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 12 months
by assessment of safety profile
Measured: Blood samples are collected at 12 months post dose
Change from the baseline statin dose at 12 months
by assessment of treatment patterns and adherence of the index statin therapy
Measured: The dose of the treated statin is collected up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCI PatientsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yundai Chen, MD,PhD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561845
- Sponsor's protocol ID
- D3560R00019
- Status last verified
- Apr 2016
- First submitted
- 16 Sep 2015
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Statins on Lipid Goal Attainment and Lipid Parameters in Percutaneous Coronary Intervention Patients
- ClinicalTrials.gov ID
- NCT02561845
- Acronym / sponsor ID
- D3560R00019
- Conditions
- PCI Patients
- Keywords
- Effectiveness of statins, on lipid goal attainment and lipid parameters in Percutaneous Coronary Intervention patients
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 28 Sep 2015 (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.
Most PCI patients are at very high cardiovascular (CV) risk, and as such here is an increased need for intensive lipid management in Percutaneous Coronary Intervention (PCI) patients and the population is well suited to demonstrating rosuvastatin's low density lipoprotein-cholesterol (LDL-C) lowering efficacy.Most PCI patients are at very high CV risk, and as such here is an increased need for intensive lipid management in PCI patients and the population is well suited to demonstrating rosuvastatin's LDL-C lowering efficacy.The purpose of this study is to observe the effectiveness of statins on lipid level reduction (LDL-C, high density lipoprotein-cholesterol (HDL-C), Triglyceride (TG), and non-HDL-C) and lipid goal attainment according to recent guidelines.
Detailed description
The number of patients receiving Percutaneous Coronary Intervention (PCI) is rapidly increasing in China. In 2013, about 450,000 Chinese patients received PCI, most of whom suffered from coronary heart disease (CHD), especially acute coronary syndrome (ACS). ACS is associated with an increased risk of cardiovascular mortality and recurrent cardiac events, underscoring the importance of identifying treatments that minimize this risk.The Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) trial suggested a benefit of lipid lowering with high-dose atorvastatin in patients with ACS. A meta-analysis of statin use in patients with ACS confirmed the benefits of early high-dose statin administration in decreasing recurrent myocardial ischemia, which suggested the clinical benefit and safety of statins were dose and statin dependent. The updated National Cholesterol Education Program Adult Treatment Panel III guidelines recommend that intensive therapy should be considered for all patients admitted to hospital for an ACS. Two meta-analyses have shown that early intensive statin therapy in patients with ACS is associated with a reduced rate of death and cardiovascular events. In the PROVE IT study, comparing atorvastatin 80 mg with pravastatin 40 mg, a significant reduction in major adverse clinical events was observed in favour of more intensive statin treatment. In that study, the median concentration of low-density LDL-C was lowered from 106 mg/dL to 62 mg/dL in the atorvastatin 80 mg group. More recently, the 2011 European Society of Cardiology (ESC)/ European Arterial Sclerosis Association (EAS) guideline for the management of dyslipidemia recommended patients with ACS are very high CV risk patients and should achieve LDL-C level <70 mg/dl or 50% reduction. In 2011 American College of Cardiology Foundation (ACCF) / American Heart Association (AHA) / (cardiovascular angiography and intervention Association)/ Association of Cardiovascular angiography and intervention (SCAI) Guideline for PCI, statin therapy which lowers LDL to <70mg/dL in very high-risk patients is recommended (IIa, B). The latest China ACS consensus also recommends using the highest dose statin treatment for the acute phase and to attain an LDL-C level of 1.8 mmol/L or 50% reduction compared with baseline in long-term treatment. However, there are very limited Chinese data demonstrating the current situation of lipid management (LDL-C on-goal rate) by different statins in real-world clinical practice.
Most PCI patients are at very high CV risk, and as such here is an increased need for intensive lipid management in PCI patients and the population is well suited to demonstrating rosuvastatin's LDL-C lowering efficacy.Most PCI patients are at very high CV risk, and as such here is an increased need for intensive lipid management in PCI patients and the population is well suited to demonstrating rosuvastatin's LDL-C lowering efficacy.The purpose of this study is to observe the effectiveness of statins on lipid level reduction (LDL-C, HDL-C, TG, and non-HDL-C) and lipid goal attainment according to recent guidelines.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rosuvastatin group | – | Drug: rosuvastatinpatients who received rosuvastatin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- PCI Patients initiating statin therapy
Key inclusion criteria (4 listed)
- Patients must have had at least one treatment for statins, during the intake period (between 01/07/2011 and 31/01/2015). The date treated with statins after hospitalization before PCI or after PCI for statin naive patients, and date of PCI procedure for statin users will be marked as an index date.
- Patients must be 18 years or older at the time of index date.
- Patients must have at least 1 month of follow-up after the index date, including continuous statin treatment, lipid profile and lab values for safety profile.
- Patients must have at least two lab values: one full lipid panel prior to or on the index date, and one at least 30 days following the index date.
Key exclusion criteria (2 listed)
- Patients with a diagnosis of Familial Hypercholesterolemia.
- Patients with malignant tumor at the index day.
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 |
|---|---|---|
| rosuvastatin5mg, 10mg, 20mg | Drug | rosuvastatin group |
Primary outcome
Change from baseline Low density lipoprotein-cholesterol (LDL-C) at 30 days
Time frame: Blood samples are collected pre-dose, 30 days post dose
by assessment of statins on the on-goal rate of LDL-C treatment of patients underwent PCI
9 secondary outcomes
Change from baseline lipid level at 30 days
Time frame: Blood samples are collected pre-dose, 30 days post dose
Change from baseline lipid level at 3 months
Time frame: Blood samples are collected pre-dose, 3 months post dose
Change from baseline lipid level at 6 months
Time frame: Blood samples are collected pre-dose, 6 months post dose
Change from baseline lipid level at 12 months
Time frame: Blood samples are collected pre-dose, 12 months post dose
number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 30 days
Time frame: Blood samples are collected at 30 days post dose
number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 3 months
Time frame: Blood samples are collected at 3 months post dose
number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 6 months
Time frame: Blood samples are collected at 6 months post dose
number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at 12 months
Time frame: Blood samples are collected at 12 months post dose
Change from the baseline statin dose at 12 months
Time frame: The dose of the treated statin is collected up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
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Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
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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.
Yundai Chen, MD,PhD principal investigator
Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of PCI Patients, run by AstraZeneca.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline Low density lipoprotein-cholesterol (LDL-C) at 30 days (time frame: Blood samples are collected pre-dose, 30 days post dose). 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 11 May 2016.