Acute Coronary SyndromesPhase 4NCT01094457
Effects of Intensive Antiplatelet Therapy for Patients With Clopidogrel Resistance After Coronary Stent Implantation
A Phase 4 study testing aspirin, clopidogrel and aspirin, clopidogrel, cilostazol in people with Acute Coronary Syndromes and Percutaneous Coronary Intervention, run by Shenyang Northern Hospital at 3 sites in China.
Trial summary
Clopidogrel resistance (CR) or low-responsiveness is associated with increased risk of ischemic events and can be detected by laboratory tests. This multicenter, randomized study is aimed to explore the efficacy and safety of intensive antiplatelet therapy (i.e. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Acute Coronary Syndromes, Percutaneous Coronary Intervention, Clopidogrel Low Responsiveness
- What is being tested?
- aspirin, clopidogrel and aspirin, clopidogrel, cilostazol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 3 sitesChina
- Study dates
- Mar 2009to Jun 2012
- 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
- aged 35 to 75 years
- acute coronary syndromes
- underwent successful coronary stent implantation
- informed consent
Who cannot join
- contraindications to antiplatelet therapy
- history of intracranial bleeding
- known bleeding disorders
- severe liver or kidney disease
- pregnancy
- left main coronary artery disease
Show all 9Show fewer
- planned non cardiac surgery within 1 year
- end stage of other serious disease with life expectancy less than 1 year
- heart failure with NYHA grade 3 to 4
Trial locations and contacts
3 sites in 1 country.
China3 sites
463 Hospital of PLA
Shenyang, Liaoning, 110000
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110016
Shenyang Northern Hospital
Shenyang, Liaoning, 110840
About this study
Clopidogrel resistance (CR) or low-responsiveness is associated with increased risk of ischemic events and can be detected by laboratory tests. This multicenter, randomized study is aimed to explore the efficacy and safety of intensive antiplatelet therapy (i.e. double clopidogrel maintenance dose and/or additional cilostazol)for patients with CR after coronary stenting.
- Conditions
- Acute Coronary Syndromes, Percutaneous Coronary Intervention, Clopidogrel Low Responsiveness
- Being tested
- aspirin, clopidogrel, aspirin, clopidogrel, cilostazol
- Keywords
- antiplatelet therapy, clopidogrel low responsiveness, acute coronary syndromes, percutaneous coronary intervention, cilostazol
- 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.
aspirin, clopidogrelDrug
patients in the standard group received standard dual antiplatelet therapy: aspirin 300mg/d for 30 days followed by 100mg/d indefinitely, clopidogrel 75mg/d for at least 1 year
aspirin, clopidogrel, cilostazolDrug
Firstly,all patients in this group were received aspirin 300mg/d and clopidogrel 150mg/d for 3 days. Then a platelet aggregation function test was performed. The regimen will lasted for another 27 days if patients were judged as responsive to current clopidogrel dose. Patients still with clopidogrel resistance were then randomly assigned to receive clopidogrel 75mg/d plus cilostazol 100mg, twice per day or clopidogrel 150mg/d plus cilostazol 50mg, twice per day for 27 days. At 30-day, a repeat platelet aggregation function test wil performed for all patients. Then a standard dual antiplatelet regimen with aspirin 100mg/d indefinitely and clopidogrel 75mg/d for at least 1 year will be prescribed for all patients.
| Study group | Role | What they receive |
|---|---|---|
| standard group | Active comparator | patients in this group received standard dual antiplatelet therapy, i.e. aspirin 300mg/d and clopidogrel 75mg/d Receives: Drug: aspirin, clopidogrel |
| intensive group | Experimental | patients in this group received intensive antiplatelet therapy and the regimen can be adjusted according to results of platelet aggregation function test by LTA Receives: Drug: aspirin, clopidogrel, cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major ischemic cardiovascular events
defined as a composite of cardiac death, myocardial infarction or stroke
Measured: 1 year
Secondary outcomes (4)
Stent thrombosis
according to ARC definition
Measured: 1 year
major adverse cardiac and cerebral events(MACCE)
defined as a composite of cardiac death, myocardial infarction, target vessel revascularization or stroke
Measured: 1 year
Hemorrhagic events
according to TIMI bleeding definition
Measured: within 1 year
reduction in ADP induced platelet aggregation
assessed by LTA (Packs-4 Aggregometer, Helena labs, Beaumont, Texas)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startMar 2009
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaling Han, Shenyang Northern Hospital
- Investigators
- Yaling Han, MD, Principal investigator, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094457
- Sponsor's protocol ID
- 825004-5
- Status last verified
- Jun 2012
- First submitted
- 26 Mar 2010
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Antiplatelet Therapy for Patients With Clopidogrel Resistance After Coronary Stent Implantation
- ClinicalTrials.gov ID
- NCT01094457
- Acronym / sponsor ID
- 825004-5
- Conditions
- Acute Coronary Syndromes, Percutaneous Coronary Intervention, Clopidogrel Low Responsiveness
- Keywords
- antiplatelet therapy, clopidogrel low responsiveness, acute coronary syndromes, percutaneous coronary intervention, cilostazol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Mar 2010 (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 resistance (CR) or low-responsiveness is associated with increased risk of ischemic events and can be detected by laboratory tests. This multicenter, randomized study is aimed to explore the efficacy and safety of intensive antiplatelet therapy (i.e. double clopidogrel maintenance dose and/or additional cilostazol)for patients with CR after coronary stenting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard group | Active comparator | Drug: aspirin, clopidogrelpatients in this group received standard dual antiplatelet therapy, i.e. aspirin 300mg/d and clopidogrel 75mg/d |
| intensive group | Experimental | Drug: aspirin, clopidogrel, cilostazolpatients in this group received intensive antiplatelet therapy and the regimen can be adjusted according to results of platelet aggregation function test by LTA |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 35 to 75 years
- acute coronary syndromes
- underwent successful coronary stent implantation
- informed consent
Key exclusion criteria (9 listed)
- contraindications to antiplatelet therapy
- history of intracranial bleeding
- known bleeding disorders
- severe liver or kidney disease
- pregnancy
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 |
|---|---|---|
| aspirin, clopidogrelpatients in the standard group received standard dual antiplatelet therapy: aspirin 300mg/d for 30 days followed by 100mg/d indefinitely, clopidogrel 75mg/d for at least 1 year | Drug | standard group |
| aspirin, clopidogrel, cilostazolFirstly,all patients in this group were received aspirin 300mg/d and clopidogrel 150mg/d for 3 days. Then a platelet aggregation function test was performed. The regimen will lasted for another 27 days if patients were judged as responsive to current clopidogrel dose. Patients still with clopidogrel resistance were then randomly assigned to receive clopidogrel 75mg/d plus cilostazol 100mg, twice per day or clopidogrel 150mg/d plus cilostazol 50mg, twice per day for 27 days. At 30-day, a repeat platelet aggregation function test wil performed for all patients. Then a standard dual antiplatelet regimen with aspirin 100mg/d indefinitely and clopidogrel 75mg/d for at least 1 year will be prescribed for all patients. | Drug | intensive group |
Primary outcome
Major ischemic cardiovascular events
Time frame: 1 year
defined as a composite of cardiac death, myocardial infarction or stroke
4 secondary outcomes
Stent thrombosis
Time frame: 1 year
major adverse cardiac and cerebral events(MACCE)
Time frame: 1 year
Hemorrhagic events
Time frame: within 1 year
reduction in ADP induced platelet aggregation
Time frame: 30 days
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 Jun 2012.
Related trials for Acute Coronary Syndromes
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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, MD principal investigator
Shenyang Northern Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aspirin, clopidogrel and aspirin, clopidogrel, cilostazol in people with Acute Coronary Syndromes and Percutaneous Coronary Intervention, run by Shenyang Northern Hospital at 3 sites 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 9 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 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 ischemic cardiovascular events (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 Jun 2012.