Acute Coronary SyndromePhase 4NCT00404053
Clopidogrel Maintaining Dosage in Acute Coronary Syndrome After Drug Eluting Stent Implantation
A Phase 4 study testing Clopidogrel in people with Acute Coronary Syndrome, run by Shenyang Northern Hospital.
Trial summary
In view of its safety profile and the results of clinical trials, clopidogrel has become the standard treatment for patients with acute coronary syndrome (ACS) and drug eluting stent(DES) implantation. Two large studies in patients with ACS shown that pretreatment with clopidogrel had beneficial effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Clopidogrel
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 2004to Nov 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with ACS and planned pretreatment with 600mg loading dose of commercially available clopidogrel (Plavix).
- between ages of 18 Years and above
- Presence of one or several stenosis in native coronary arteries requiring PCI and suitable for DES implantation.
- 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 clopidogrel and aspirin (White blood cells counts < 4×109/L or platelet counts <100 g.l-1 ;creatinine clearance <25 ml • min-1 ;active liver disease).
- use of glycoprotein IIb/IIIa inhibitors before PCI.
About this study
Official title: One Year Effects of Different Clopidogrel Maintaining Dosage on Patients With Acute Coronary Syndrome Undergoing Coronary Drug Eluting Stent Implantation
In view of its safety profile and the results of clinical trials, clopidogrel has become the standard treatment for patients with acute coronary syndrome (ACS) and drug eluting stent(DES) implantation. Two large studies in patients with ACS shown that pretreatment with clopidogrel had beneficial effects. The pretreatment regimens were given a mean of 6 days before intervention in the observational PCI-CURE trial and 3 to 24 h in the randomized CREDO trial respectively. Accordingly, current clinical practice carries out pretreatment with a 300mg loading dose of clopidogrel at least 6 h before DES implantation procedure in patients with ACS. Compared with the 300mg clopidogrel loading dose, 600mg loading dose exhibited a superior antiplatelet effect and improved short-term clinical outcomes in patients undergoing DES implantation for ACS according to recent a few publications. But despite clopidogrel 600mg loading dose and the routine use of 75mg per day as a maintaining dose, recurrent ischemic events occurred in some patients. Therefore, the goal of this study will evaluate the efficacy of a 600mg loading dose of clopidogrel plus 150mg per day as a maintaining dose in patients with ACS undergoing DES implantation.
ACS patients undergoing DES implantation who receive planned 600mg loading dose clopidogrel pretreatment are eligible for the study. All enrolled patients will be randomized to receive daily clopidogrel 75 mg or 150mg as maintaining doses starting as soon as post-PCI, in addition to daily aspirin 100 mg, and lasted for the first month after DES implantation. One month later, all patients receive daily clopidogrel 75mg until 9~12month after DES implantation. The primary endpoints include death of all causes, myocardial infarction, revascularization of the target lesson, sub-acute and late stent thrombosis one year after PCI, The secondary endpoints are major and minor bleeding events. The study will be powered to test the hypothesis that higher maintaining dose(150mg) of clopidogrel will reduce major adverse cardiac events compared to currently used common dose(75 mg) at one year following PCI.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Clopidogrel
- 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.
ClopidogrelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startDec 2004
- Study completionNov 2006
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.
- 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)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yaling Han, Dr, Principal investigator, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404053
- Sponsor's protocol ID
- NH-2004-A003
- Status last verified
- Nov 2006
- First submitted
- 24 Nov 2006
- Last updated
- 29 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Effects of Different Clopidogrel Maintaining Dosage on Patients With Acute Coronary Syndrome Undergoing Coronary Drug Eluting Stent Implantation
- ClinicalTrials.gov ID
- NCT00404053
- Acronym / sponsor ID
- NH-2004-A003
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- Dec 2004
- Study completion
- Nov 2006
- First posted
- 27 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.
In view of its safety profile and the results of clinical trials, clopidogrel has become the standard treatment for patients with acute coronary syndrome (ACS) and drug eluting stent(DES) implantation. Two large studies in patients with ACS shown that pretreatment with clopidogrel had beneficial effects. The pretreatment regimens were given a mean of 6 days before intervention in the observational PCI-CURE trial and 3 to 24 h in the randomized CREDO trial respectively. Accordingly, current clinical practice carries out pretreatment with a 300mg loading dose of clopidogrel at least 6 h before DES implantation procedure in patients with ACS. Compared with the 300mg clopidogrel loading dose, 600mg loading dose exhibited a superior antiplatelet effect and improved short-term clinical outcomes in patients undergoing DES implantation for ACS according to recent a few publications. But despite clopidogrel 600mg loading dose and the routine use of 75mg per day as a maintaining dose, recurrent ischemic events occurred in some patients. Therefore, the goal of this study will evaluate the efficacy of a 600mg loading dose of clopidogrel plus 150mg per day as a maintaining dose in patients with ACS undergoing DES implantation.
ACS patients undergoing DES implantation who receive planned 600mg loading dose clopidogrel pretreatment are eligible for the study. All enrolled patients will be randomized to receive daily clopidogrel 75 mg or 150mg as maintaining doses starting as soon as post-PCI, in addition to daily aspirin 100 mg, and lasted for the first month after DES implantation. One month later, all patients receive daily clopidogrel 75mg until 9~12month after DES implantation. The primary endpoints include death of all causes, myocardial infarction, revascularization of the target lesson, sub-acute and late stent thrombosis one year after PCI, The secondary endpoints are major and minor bleeding events. The study will be powered to test the hypothesis that higher maintaining dose(150mg) of clopidogrel will reduce major adverse cardiac events compared to currently used common dose(75 mg) at one year following PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with ACS and planned pretreatment with 600mg loading dose of commercially available clopidogrel (Plavix).
- between ages of 18 Years and above
- Presence of one or several stenosis in native coronary arteries requiring PCI and suitable for DES implantation.
- Willing and able to sign informed consent.
Key exclusion criteria (5 listed)
- A history of bleeding diathesis.
- New York Heart Association functional class IV.
- Prior PCI or coronary bypass grafting < 3 months.
- contraindications to clopidogrel and aspirin (White blood cells counts < 4×109/L or platelet counts <100 g.l-1 ;creatinine clearance <25 ml • min-1 ;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 |
|---|---|---|
| Clopidogrel | Drug | – |
Primary outcome
Not reported in the source record.
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 29 Nov 2006.
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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, Dr principal investigator
Shenyang Northern Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel in people with Acute Coronary Syndrome, run by Shenyang Northern Hospital.
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 5 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 29 Nov 2006. 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.
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.
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 29 Nov 2006.