Non-ST Segment Elevation Myocardial InfarctionPhase 4ISCAPNCT01293097
Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing PCI
A Phase 4 study testing Atorvastatin and Statin in people with Non-ST Segment Elevation Myocardial Infarction and Unstable Angina Pectoris, run by Peking University First Hospital at 1 site in China.
Trial summary
This randomized, open label, controlled, parallel group study is designed to test whether 2-day high dose atorvastatin administration before PCI and 30-day continuous intensive atorvastatin treatment is superior to usual care, in terms of peri-PCI cardiovascular events, as well as 6-month prognosis. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Non-ST Segment Elevation Myocardial Infarction, Unstable Angina Pectoris, Stable Angina Pectoris
- What is being tested?
- Atorvastatin and Statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,884 participants
- Where
- 1 siteChina
- Study dates
- Jun 2010to Oct 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-75 years old
- Patients with clinical diagnosis of NSTE-ACS (unstable angina or NSTE acute myocardial infarction) or stable angina pectoris (SAP) scheduled for selective coronary angiography
- Evidence of a personally signed and dated informed consent document
Who cannot join
- Patients presenting with ST-segment elevation acute myocardial infarction (STEMI) or high risk NSTE-ACS, warranting emergency coronary angiography:
- Experienced STEMI within previous 30 days
- Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin (such as simvastatin 20mg/d, pravastatin 40mg/d, fluvastatin 80mg/d or rosuvastatin 5mg/d ) in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment.
- Anticipated repeated PCI within 6 months
- LDL-C < 1.8mmol/L in patients without statin therapy in 1 months
- Endstage congestive heart failure, or LVEF < 30%
Show all 16Show fewer
- Active hepatic disease or hepatic dysfunction, or AST/ALT > 1.5UNL
- Myopathy or increased creatine kinase (CK>2 UNL)
- White blood cell < 4×109/L or platelet < 100×109/L
- Severe renal dysfunction(Scr > 3 mg/dl or 264μmol/L)
- 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
Division of Cardiology, Peking University First Hospital
Beijing, 10034
About this study
Official title: Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing Percutaneous Coronary Intervention(PCI)
This randomized, open label, controlled, parallel group study is designed to test whether 2-day high dose atorvastatin administration before PCI and 30-day continuous intensive atorvastatin treatment is superior to usual care, in terms of peri-PCI cardiovascular events, as well as 6-month prognosis. The goal is to set up an optimized protocol for peri-PCI statin treatment in Chinese CHD patients. Safety will also be observed.
Read the detailed description
The study objective is to test whether 2-day high dose atorvastatin administration before PCI and 30-day continuous intensive atorvastatin treatment is superior to usual care, in terms of peri-PCI cardiovascular events, as well as 6-month prognosis.
2160 patients with non-ST segment elevated acute coronary syndrome (ACS)or stable angina pectoris (SAP) scheduled for selective PCI are randomized into two groups. The study group is given atorvastatin 80 mg/d×2d before PCI while the control group receives usual care. After angiography, patients who are not undergoing PCI procedure will be excluded from the study as selection failure. After PCI procedure, the study group is given atorvastatin 40mg/d until 30 days after PCI while the control group receive usual care. The last visit will be at 6 months after PCI. Patients data such as troponin, CK-MB, Scr, CCR, ALT, AST before and after procedure will be recorded. 1100 effective patients will be finally enrolled.
The study will be conducted at about 54 centers in China. Data will be collected on 2,100 NSTE or SAP patients undergoing PCI.
Primary outcome: MACE within 30 days after PCI. Secondary outcome: Post-procedural change of inflammatory biomarkers (hs-CRP); Morbidity of CIN; Proportion of patients who experience at least once AST > 3ULN，ALT > 3ULN or CK > 5ULN after initiation of study treatment. Proportion of patients who experience at least once AST, ALT, or CK>ULN after initiation of study treatment; Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events; Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.
- Conditions
- Non-ST Segment Elevation Myocardial Infarction, Unstable Angina Pectoris, Stable Angina Pectoris
- Being tested
- Atorvastatin, Statin
- Medical subject headings
- Angina, Unstable, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Liptor
Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
StatinDrug
Also called Liptor, Zocor, Pravachol, Lescol
Usual care, but statin dose should not be higher than that described in exclusion criteria
| Study group | Role | What they receive |
|---|---|---|
| Intensive statin therapy | Active comparator | Atorvastatin 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 | Usual care, but 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 MACEs after PCI
30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI
Measured: 30 days after PCI
Secondary outcomes (5)
Post-procedural change of inflammatory biomarkers (hs-CRP)
Post-procedural change of inflammatory biomarkers (hs-CRP)
Measured: 24 hours after PCI
Morbidity of CIN
Morbidity of CIN
Measured: 48 hours after PCI
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 after PCI
Adverse events
Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events
Measured: 6 months after PCI
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 after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startJun 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ST Segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- 2,884 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Huo, Peking University First Hospital
- Investigators
- Yong Huo, MD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293097
- Sponsor's protocol ID
- ISCAP
- Acronym
- ISCAP
- Status last verified
- Apr 2013
- First submitted
- 9 Feb 2011
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing Percutaneous Coronary Intervention(PCI)
- ClinicalTrials.gov ID
- NCT01293097
- Acronym / sponsor ID
- ISCAP / ISCAP
- Conditions
- Non-ST Segment Elevation Myocardial Infarction, Unstable Angina Pectoris, Stable Angina Pectoris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,884 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Feb 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.
This randomized, open label, controlled, parallel group study is designed to test whether 2-day high dose atorvastatin administration before PCI and 30-day continuous intensive atorvastatin treatment is superior to usual care, in terms of peri-PCI cardiovascular events, as well as 6-month prognosis. The goal is to set up an optimized protocol for peri-PCI statin treatment in Chinese CHD patients. Safety will also be observed.
Detailed description
The study objective is to test whether 2-day high dose atorvastatin administration before PCI and 30-day continuous intensive atorvastatin treatment is superior to usual care, in terms of peri-PCI cardiovascular events, as well as 6-month prognosis.
2160 patients with non-ST segment elevated acute coronary syndrome (ACS)or stable angina pectoris (SAP) scheduled for selective PCI are randomized into two groups. The study group is given atorvastatin 80 mg/d×2d before PCI while the control group receives usual care. After angiography, patients who are not undergoing PCI procedure will be excluded from the study as selection failure. After PCI procedure, the study group is given atorvastatin 40mg/d until 30 days after PCI while the control group receive usual care. The last visit will be at 6 months after PCI. Patients data such as troponin, CK-MB, Scr, CCR, ALT, AST before and after procedure will be recorded. 1100 effective patients will be finally enrolled.
The study will be conducted at about 54 centers in China. Data will be collected on 2,100 NSTE or SAP patients undergoing PCI.
Primary outcome: MACE within 30 days after PCI. Secondary outcome: Post-procedural change of inflammatory biomarkers (hs-CRP); Morbidity of CIN; Proportion of patients who experience at least once AST > 3ULN，ALT > 3ULN or CK > 5ULN after initiation of study treatment. Proportion of patients who experience at least once AST, ALT, or CK>ULN after initiation of study treatment; Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events; Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive statin therapy | Active comparator | Drug: AtorvastatinAtorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care |
| Usual care | Other | Drug: StatinUsual care, but statin dose should not be higher than that described in exclusion criteria. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20-75 years old
- Patients with clinical diagnosis of NSTE-ACS (unstable angina or NSTE acute myocardial infarction) or stable angina pectoris (SAP) scheduled for selective coronary angiography
- Evidence of a personally signed and dated informed consent document
Key exclusion criteria (16 listed)
- Patients presenting with ST-segment elevation acute myocardial infarction (STEMI) or high risk NSTE-ACS, warranting emergency coronary angiography:
- Experienced STEMI within previous 30 days
- Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin (such as simvastatin 20mg/d, pravastatin 40mg/d, fluvastatin 80mg/d or rosuvastatin 5mg/d ) in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment.
- Anticipated repeated PCI within 6 months
- LDL-C < 1.8mmol/L in patients without statin therapy in 1 months
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 |
|---|---|---|
| AtorvastatinAlso: LiptorAtorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care | Drug | Intensive statin therapy |
| StatinAlso: Liptor, Zocor, Pravachol, LescolUsual care, but statin dose should not be higher than that described in exclusion criteria | Drug | Usual care |
Primary outcome
30-day MACEs after PCI
Time frame: 30 days after PCI
30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI
5 secondary outcomes
Post-procedural change of inflammatory biomarkers (hs-CRP)
Time frame: 24 hours after PCI
Morbidity of CIN
Time frame: 48 hours after PCI
Elevation of ALT, AST and CK
Time frame: 6 months after PCI
Adverse events
Time frame: 6 months after PCI
Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events
Time frame: 6 months after PCI
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 30 Apr 2013.
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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 principal investigator
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 Non-ST Segment Elevation Myocardial Infarction and Unstable Angina Pectoris, run by Peking University First 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 16 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 30 Apr 2013. 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?
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?
30-day MACEs after PCI (time frame: 30 days 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 30 Apr 2013.