Ischemic Heart DiseasePhase 4NCT00404781
Effects of Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention
A Phase 4 study testing cilostazol in addition to aspirin and clopidogrel in people with Ischemic Heart Disease and Acute Coronary Syndromes, run by Shenyang Northern Hospital at 1 site in China.
Trial summary
Effects of dual antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary intervention has been proven. However, patients with low response to those agents are reported be associated with adverse clinical outcomes. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Ischemic Heart Disease, Acute Coronary Syndromes
- What is being tested?
- cilostazol in addition to aspirin and clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 1 siteChina
- Study dates
- Jun 2006to Jun 2007
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-ST-segment elevated acute coronary syndromes
- patients undergoing selective or emergent PCI
Who cannot join
- administration of clopidogrel or ticlopidine within 2 weeks
- ST-segment elevated myocardial infarction
- contraindications of antiplatelet therapy
- history of intracranial bleeding
- known bleeding disorders
- severe liver or kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Personal Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes
Effects of dual antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary intervention has been proven. However, patients with low response to those agents are reported be associated with adverse clinical outcomes. We suppose that optimized antiplatelet therapy for individual patients based on platelet function assay may improve long-term outcomes especially in patients with high risk of thrombosis. In this prospective randomized study, patients in control group all receive standard dual antiplatelet therapy, and patients in optimized group receive different antiplatelet therapy according to risk stratification.
- Conditions
- Ischemic Heart Disease, Acute Coronary Syndromes
- Being tested
- cilostazol in addition to aspirin and clopidogrel
- Keywords
- ischemic heart disease, acute coronary syndromes, percutaneous transluminal coronary angioplasty, platelet function, aspirin, clopidogrel, cilostazol
- 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.
cilostazol in addition to aspirin and clopidogrelDrug
| Study group | Role | What they receive |
|---|---|---|
| optimal antiplatelet | Experimental | cilostazol in addition to aspirin and clopdidogrel for pts with clopidogrel resistance Receives: Drug: cilostazol in addition to aspirin and clopidogrel |
| standard antiplatelet | Active comparator | aspirin and clopidogrel for all patients Receives: Drug: cilostazol in addition to aspirin and clopidogrel |
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 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 posted29 Nov 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2007
- Study completionJun 2007
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
- 305 participants (actual)
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
- NCT00404781
- Sponsor's protocol ID
- NH-2006-C001
- Status last verified
- Oct 2009
- First submitted
- 28 Nov 2006
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Personal Optimized Antiplatelet Treatment After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT00404781
- Acronym / sponsor ID
- NH-2006-C001
- Conditions
- Ischemic Heart Disease, Acute Coronary Syndromes
- Keywords
- ischemic heart disease, acute coronary syndromes, percutaneous transluminal coronary angioplasty, platelet function, aspirin, clopidogrel, cilostazol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 29 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.
Effects of dual antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary intervention has been proven. However, patients with low response to those agents are reported be associated with adverse clinical outcomes. We suppose that optimized antiplatelet therapy for individual patients based on platelet function assay may improve long-term outcomes especially in patients with high risk of thrombosis. In this prospective randomized study, patients in control group all receive standard dual antiplatelet therapy, and patients in optimized group receive different antiplatelet therapy according to risk stratification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| optimal antiplatelet | Experimental | Drug: cilostazol in addition to aspirin and clopidogrelcilostazol in addition to aspirin and clopdidogrel for pts with clopidogrel resistance |
| standard antiplatelet | Active comparator | Drug: cilostazol in addition to aspirin and clopidogrelaspirin and clopidogrel for all patients |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- non-ST-segment elevated acute coronary syndromes
- patients undergoing selective or emergent PCI
Key exclusion criteria (6 listed)
- administration of clopidogrel or ticlopidine within 2 weeks
- ST-segment elevated myocardial infarction
- contraindications of antiplatelet therapy
- history of intracranial bleeding
- known bleeding disorders
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 |
|---|---|---|
| cilostazol in addition to aspirin and clopidogrel | Drug | optimal antiplatelet, standard antiplatelet |
Primary outcome
Major adverse cardiac and cerebral events at 1 year
Time frame: 1 year
1 secondary outcome
Hemorrhage 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 14 Oct 2009.
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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 cilostazol in addition to aspirin and clopidogrel 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 2 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 14 Oct 2009. 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 14 Oct 2009.