Ischemic Heart DiseasePhase 4NCT00405717
Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel
A Phase 4 study testing atorvastatin,pravastatin in people with Ischemic Heart Disease and Acute Coronary Syndromes, run by Shenyang Northern Hospital at 1 site in China.
Trial summary
Clopidogrel and statins are frequently coadministered in patients with ischemic heart diseases. Recent reports suggested that clopidogrel's effectiveness in inhibiting adenosine diphosphate (ADP)-induced platelets aggregation is attenuated by co-administration of certain statins. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Heart Disease, Acute Coronary Syndromes
- What is being tested?
- atorvastatin,pravastatin
- How many people
- 1,300 participants
- Where
- 1 siteChina
- Study dates
- Feb 2006to May 2008
- 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
- Diagnosed with ACS.
- Between ages of 18 Years and 85 years.
- Presence of one or several stenosis in native coronary arteries requiring PCI.
- Willing and able to sign informed consent.
Who cannot join
- A history of bleeding diathesis.
- New York Heart Association functional class IV.
- Prior PCI or coronary bypass grafting < 3 months.
- Contraindications to statins, clopidogrel and aspirin (White blood cells counts < 4×109/L or platelet counts <100 g/l; creatinine clearance <25 ml/ min; active liver disease).
- Use of glycoprotein IIb/IIIa inhibitors before PCI.
- Use of statins before PCI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention
Clopidogrel and statins are frequently coadministered in patients with ischemic heart diseases. Recent reports suggested that clopidogrel's effectiveness in inhibiting adenosine diphosphate (ADP)-induced platelets aggregation is attenuated by co-administration of certain statins. The objective of the present study is to define which kind of statins might interfere with the antiaggregation property of clopidogrel in patients with acute coronary Syndrome after percutaneous coronary intervention (PCI).
In this prospective randomized study, all patients in test group will receive clopidogrel plus atorvastatin, and all patients in control group will receive clopidogrel plus pravastatin. All patients will be followed up for one year. The primary endpoints include death, non fatal AMI, urgent revascularization. The secondary endpoints include hemorrhage events and subacute thrombosis events at 1 year.
- Conditions
- Ischemic Heart Disease, Acute Coronary Syndromes
- Being tested
- atorvastatin,pravastatin
- Keywords
- ischemic heart disease, acute coronary syndromes, percutaneous transluminal coronary angioplasty, statin, clopidogrel
- Medical subject headings
- Myocardial Ischemia, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatin,pravastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiac and cerebral events at 1 year
Measured: 1 year
Secondary outcomes (1)
hemorrhage events and subacute thrombosis events at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startFeb 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yaling Han, M.D., Principal investigator, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405717
- Sponsor's protocol ID
- NH-2006-C002
- Status last verified
- Nov 2008
- First submitted
- 28 Nov 2006
- Last updated
- 7 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT00405717
- Acronym / sponsor ID
- NH-2006-C002
- Conditions
- Ischemic Heart Disease, Acute Coronary Syndromes
- Keywords
- ischemic heart disease, acute coronary syndromes, percutaneous transluminal coronary angioplasty, statin, clopidogrel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 30 Nov 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.
Clopidogrel and statins are frequently coadministered in patients with ischemic heart diseases. Recent reports suggested that clopidogrel's effectiveness in inhibiting adenosine diphosphate (ADP)-induced platelets aggregation is attenuated by co-administration of certain statins. The objective of the present study is to define which kind of statins might interfere with the antiaggregation property of clopidogrel in patients with acute coronary Syndrome after percutaneous coronary intervention (PCI).
In this prospective randomized study, all patients in test group will receive clopidogrel plus atorvastatin, and all patients in control group will receive clopidogrel plus pravastatin. All patients will be followed up for one year. The primary endpoints include death, non fatal AMI, urgent revascularization. The secondary endpoints include hemorrhage events and subacute thrombosis events at 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with ACS.
- Between ages of 18 Years and 85 years.
- Presence of one or several stenosis in native coronary arteries requiring PCI.
- Willing and able to sign informed consent.
Key exclusion criteria (6 listed)
- A history of bleeding diathesis.
- New York Heart Association functional class IV.
- Prior PCI or coronary bypass grafting < 3 months.
- Contraindications to statins, clopidogrel and aspirin (White blood cells counts < 4×109/L or platelet counts <100 g/l; creatinine clearance <25 ml/ min; active liver disease).
- Use of glycoprotein IIb/IIIa inhibitors before PCI.
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 |
|---|---|---|
| atorvastatin,pravastatin | Drug | – |
Primary outcome
major adverse cardiac and cerebral events at 1 year
Time frame: 1 year
1 secondary outcome
hemorrhage events and subacute thrombosis events at 1 year
Time frame: 1 year
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 7 Nov 2008.
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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.
Yaling Han, M.D. principal investigator
Shenyang Northern 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,pravastatin in people with Ischemic Heart Disease and Acute Coronary Syndromes, run by Shenyang Northern 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 4 inclusion and 6 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 7 Nov 2008. 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?
major adverse cardiac and cerebral events at 1 year (time frame: 1 year). 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 7 Nov 2008.