Coronary Artery DiseasePhase 4spiritNCT01371058
Study of Policosanol to Improve Platelet Reactivity After Percutaneous Coronary Stent Implantation (PCI)
A Phase 4 study testing high maintenance clopidogrel, routine dual antiplatelet and policosanol plus dual antiplatelet in people with Coronary Artery Disease, run by Shenyang Northern Hospital at 1 site in China.
Trial summary
Thrombotic event is one of the most serious complications of coronary artery disease, which often result in myocardial infarction and even death. Even according to the standard guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic events, in high-risk patients, the proportion is… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- high maintenance clopidogrel, routine dual antiplatelet and policosanol plus dual antiplatelet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Sep 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with coronary heart disease and had received coronary stenting
- high on-treatment platelet reactivity defined as an ADP-induced platelet aggregation (by LTA)> 65% at 24 hr after clopidogrel loading (300 ~ 600mg)or 5 days after maintenance dose treatment (75mg / d)
- Informed Consent
Who cannot join
- receiving GP IIb / IIIa receptor antagonist treatment within 24h before enrollment
- using cilostazol within 7d before enrollment
- aspirin, clopidogrel or policosanol allergies
- NYHA grade III ~ IV
- planned elective coronary revascularization for multivessel coronary artery disease
- long term warfarin treatment after persistent atrial fibrillation, valve surgery or other circumstance
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- Severe liver or kidney dysfunction
- Active ulcer or a history of recent gastrointestinal bleeding
- History of coagulation disorder, or recent history of active bleeding
- history of intracranial hemorrhage within 6 months
- Pregnancy
- LDL less than 70mg/dL
- Severe systemic diseases with life expectancy less than 1 year
- planned surgery within next 6 months
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: Study of Policosanol to Improve High on Clopidogrel Platelet Reactivity After Percutaneous Coronary Stent Implantation(Spirit)
Thrombotic event is one of the most serious complications of coronary artery disease, which often result in myocardial infarction and even death. Even according to the standard guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic events, in high-risk patients, the proportion is higher, this phenomenon is called anti-platelet drug resistance in clinical practice
The aim of this multicenter prospective, randomized, controlled study is to observed policosanol on aspirin or clopidogrel resistance in patients with platelet aggregation after Percutaneous Coronary Stent Implantation (PCI) and occurrence of platelet aggregation and short-term prognosis to find new ways to the prevention of platelet aggregation .
Read the detailed description
Thrombotic event is one of the most serious complications in coronary artery disease, which often result in myocardial infarction and even death. Even according to the standard guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic events, in high-risk patients, the proportion is higher, this phenomenon is called anti-platelet drug resistance in clinical practice
- Conditions
- Coronary Artery Disease
- Being tested
- high maintenance clopidogrel, routine dual antiplatelet, policosanol plus dual antiplatelet
- Keywords
- high on-treatment platelet reactivity, percutaneous coronary intervention, stent thrombosis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high maintenance clopidogrelDrug
clopidogrel 150 mg/d for 30 days followed by 75 mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；
routine dual antiplateletDrug
clopidogel 75mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；
policosanol plus dual antiplateletDrug
aspirin 300 mg/d for 1 month followed by 100 mg/d chronically； clopidogrel 75 mg/d for at least 1 year policosanol 40mg/d for 6 months
| Study group | Role | What they receive |
|---|---|---|
| routine dual antiplatelet | Active comparator | asprin 300mg/d for 1 month followed by 100mg/d chronically； clopidogrel 75mg/d for 1year. Receives: Drug: routine dual antiplatelet |
| high maintenance clopidogrel | Experimental | aspirin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 150mg/d for 1 month followed by 75mg/d for at least 1 year. Receives: Drug: high maintenance clopidogrel |
| policosanol plus dual antiplatelet | Experimental | asprin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 75mg/d for at least 1 year; Policosanol 40mg/d for 6months. Receives: Drug: policosanol plus dual antiplatelet |
What is being measured
The primary outcome is the main question the study is designed to answer.
reversion rate of HPR
reversion was defined as platelet aggregation <65%
Measured: 30 days
Secondary outcomes (2)
major adverse cardiovascular events
including cardiac death, non-fatal myocardial infarction and target vessel revascularization
Measured: 1 year
Stent thrombosis and TIMI bleeding events
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 posted10 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yaling, Shenyang Northern Hospital
- Investigators
- Yaling Han, MD, Principal investigator, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371058
- Sponsor's protocol ID
- NH-20110530
- Acronym
- spirit
- Status last verified
- Dec 2015
- First submitted
- 31 May 2011
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Policosanol to Improve High on Clopidogrel Platelet Reactivity After Percutaneous Coronary Stent Implantation(Spirit)
- ClinicalTrials.gov ID
- NCT01371058
- Acronym / sponsor ID
- spirit / NH-20110530
- Conditions
- Coronary Artery Disease
- Keywords
- high on-treatment platelet reactivity, percutaneous coronary intervention, stent thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 10 Jun 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.
Thrombotic event is one of the most serious complications of coronary artery disease, which often result in myocardial infarction and even death. Even according to the standard guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic events, in high-risk patients, the proportion is higher, this phenomenon is called anti-platelet drug resistance in clinical practice
The aim of this multicenter prospective, randomized, controlled study is to observed policosanol on aspirin or clopidogrel resistance in patients with platelet aggregation after Percutaneous Coronary Stent Implantation (PCI) and occurrence of platelet aggregation and short-term prognosis to find new ways to the prevention of platelet aggregation .
Detailed description
Thrombotic event is one of the most serious complications in coronary artery disease, which often result in myocardial infarction and even death. Even according to the standard guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic events, in high-risk patients, the proportion is higher, this phenomenon is called anti-platelet drug resistance in clinical practice
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| routine dual antiplatelet | Active comparator | Drug: routine dual antiplateletasprin 300mg/d for 1 month followed by 100mg/d chronically； clopidogrel 75mg/d for 1year. |
| high maintenance clopidogrel | Experimental | Drug: high maintenance clopidogrelaspirin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 150mg/d for 1 month followed by 75mg/d for at least 1 year. |
| policosanol plus dual antiplatelet | Experimental | Drug: policosanol plus dual antiplateletasprin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 75mg/d for at least 1 year; Policosanol 40mg/d for 6months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with coronary heart disease and had received coronary stenting
- high on-treatment platelet reactivity defined as an ADP-induced platelet aggregation (by LTA)> 65% at 24 hr after clopidogrel loading (300 ~ 600mg)or 5 days after maintenance dose treatment (75mg / d)
- Informed Consent
Key exclusion criteria (14 listed)
- receiving GP IIb / IIIa receptor antagonist treatment within 24h before enrollment
- using cilostazol within 7d before enrollment
- aspirin, clopidogrel or policosanol allergies
- NYHA grade III ~ IV
- planned elective coronary revascularization for multivessel coronary artery disease
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 |
|---|---|---|
| high maintenance clopidogrelclopidogrel 150 mg/d for 30 days followed by 75 mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically； | Drug | high maintenance clopidogrel |
| routine dual antiplateletclopidogel 75mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically； | Drug | routine dual antiplatelet |
| policosanol plus dual antiplateletaspirin 300 mg/d for 1 month followed by 100 mg/d chronically； clopidogrel 75 mg/d for at least 1 year policosanol 40mg/d for 6 months | Drug | policosanol plus dual antiplatelet |
Primary outcome
reversion rate of HPR
Time frame: 30 days
reversion was defined as platelet aggregation <65%
2 secondary outcomes
major adverse cardiovascular events
Time frame: 1 year
Stent thrombosis and TIMI bleeding events
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 16 Dec 2015.
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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, MD 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 high maintenance clopidogrel, routine dual antiplatelet and policosanol plus dual antiplatelet in people with Coronary Artery Disease, 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 3 inclusion and 14 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 16 Dec 2015. 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?
reversion rate of HPR (time frame: 30 days). 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 16 Dec 2015.