Acute Coronary SyndromesPhase 4NCT01418794
Efficacy and Safety of the YUKON Drug Eluting Stent in Diffuse Coronary Artery Disease
A Phase 4 study testing High dose rapamycin stent and Low dose rapamycin stent in people with Acute Coronary Syndromes, run by Shenyang Northern Hospital at 4 sites in China.
Trial summary
Polymer carried by drug-eluting stents may increase inflammatory response and thrombosis. Our previous study showed that polymer-free rapamycin-coated stents brings dose-dependent reduction in restenosis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- High dose rapamycin stent and Low dose rapamycin stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 606 participants
- Where
- 4 sitesChina
- Study dates
- Oct 2010to Nov 2011
- 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
- Age from 18-85 years old, male or nonpregnant women
- asymptomatic ischemia, stable or unstable angina, old myocardial infarction patients
- at least one target lesion length ≥ 20 mm (Visual method)
- Target lesion diameter 2.5mm-4.0 mm (Visual method)
- Target lesion diameter stenosis ≥ 70%
- Patients who has indications for coronary artery bypass graft (CABG) surgery
- Patients who is voluntary, understand the purpose of the study, willing to accept angiography and clinical follow-up
Who cannot join
- Acute myocardial infarction for less than 1 week
- Bridge vascular disease
- In-stent restenosis lesions
- Patient with bleeding tendency, history of active peptic ulcer, History of cerebral hemorrhage or subarachnoid hemorrhage, history of stroke within half year, contraindications to anticoagulant therapy and antiplatelet
- Allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast agent, rapamycin and metal
- Life expectancy is less than 12 months
Show all 11Show fewer
- Patient who has participated in other clinical trials but does not meet the deadline of the primary endpoint
- Poor patient compliance
- Heart transplant recipient
- Patient who had other stent implanted within 1 year
- Patient who has multi-vessel disease(Long lesions) and has already received other stent implantation
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081
Bo Yu, MD, +86-451-86605346, yubodr@163.com
- Recruiting
Shenyang Northern Hospital
Shenyang, Liaoning, 110016
Yi Li, MD, +86-24-28851168, doctorliyi@126.com
- Recruiting
Armed Police Force Medical College Hospital
Tianjin, Tianjin Municipality, 300162
Tie-Min Jiang, MD, +86-22-60578777, wjyxyfy@126.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Chuan-Yu Gao, MD, +86-371-65580011, Gaocy2000@yahoo.com.cn
About this study
Polymer carried by drug-eluting stents may increase inflammatory response and thrombosis. Our previous study showed that polymer-free rapamycin-coated stents brings dose-dependent reduction in restenosis. This prospective, multicenter, randomized controlled clinical trials aimed to explore efficacy and safety of the YUKON drug eluting stent in diffuse coronary artery disease.
- Conditions
- Acute Coronary Syndromes
- Being tested
- High dose rapamycin stent, Low dose rapamycin stent
- Keywords
- Acute Coronary Syndromes, Drug eluting stent, Diffused lesion
- 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.
High dose rapamycin stentDevice
Concentration of rapamycin is 2.5%
Low dose rapamycin stentDevice
Concentration of rapamycin is 1.5%
| Study group | Role | What they receive |
|---|---|---|
| Low dose rapamycin group | Active comparator | Concentration of rapamycin was 1.5% Receives: Device: Low dose rapamycin stent |
| High dose rapamycin group | Experimental | Concentration of rapamycin is 2.5% Receives: Device: High dose rapamycin stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA)
Measured: 270 days
Secondary outcomes (4)
Restenosis rate in Stent, stent proximal edge, distal edge of stent and the lesion segment
Measured: 270 days
Composite end point of major adverse cardiac events(MACE)
Composite end point of cardiac death, all Q-wave and non-Q wave myocardial infarction, clinical-driven target lesion revascularisation
Measured: 30 days, 6 months, 9 months, 1 year
Stent thrombosis events after PCI for 24 hours, 30 days and 1 year
according to ARC definition
Measured: 24 hours, 30 days and 1 year
Success rate of stent implantation
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 posted17 Aug 2011 (estimated)
- Study startOct 2010
- Primary completionNov 2011 (estimated)
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 606 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ya-Ling Han, MD, Principal investigator, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418794
- Sponsor's protocol ID
- SYNH-20101010
- Status last verified
- Oct 2010
- First submitted
- 16 Aug 2011
- Last updated
- 17 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the YUKON Drug Eluting Stent in Diffuse Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01418794
- Acronym / sponsor ID
- SYNH-20101010
- Conditions
- Acute Coronary Syndromes
- Keywords
- Acute Coronary Syndromes, Drug eluting stent, Diffused lesion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 606 participants (estimated)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Nov 2011 (estimated)
- First posted
- 17 Aug 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.
Polymer carried by drug-eluting stents may increase inflammatory response and thrombosis. Our previous study showed that polymer-free rapamycin-coated stents brings dose-dependent reduction in restenosis. This prospective, multicenter, randomized controlled clinical trials aimed to explore efficacy and safety of the YUKON drug eluting stent in diffuse coronary artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose rapamycin group | Active comparator | Device: Low dose rapamycin stentConcentration of rapamycin was 1.5% |
| High dose rapamycin group | Experimental | Device: High dose rapamycin stentConcentration of rapamycin is 2.5% |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age from 18-85 years old, male or nonpregnant women
- asymptomatic ischemia, stable or unstable angina, old myocardial infarction patients
- at least one target lesion length ≥ 20 mm (Visual method)
- Target lesion diameter 2.5mm-4.0 mm (Visual method)
- Target lesion diameter stenosis ≥ 70%
Key exclusion criteria (11 listed)
- Acute myocardial infarction for less than 1 week
- Bridge vascular disease
- In-stent restenosis lesions
- Patient with bleeding tendency, history of active peptic ulcer, History of cerebral hemorrhage or subarachnoid hemorrhage, history of stroke within half year, contraindications to anticoagulant therapy and antiplatelet
- Allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast agent, rapamycin and metal
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 dose rapamycin stentConcentration of rapamycin is 2.5% | Device | High dose rapamycin group |
| Low dose rapamycin stentConcentration of rapamycin is 1.5% | Device | Low dose rapamycin group |
Primary outcome
270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA)
Time frame: 270 days
4 secondary outcomes
Restenosis rate in Stent, stent proximal edge, distal edge of stent and the lesion segment
Time frame: 270 days
Composite end point of major adverse cardiac events(MACE)
Time frame: 30 days, 6 months, 9 months, 1 year
Stent thrombosis events after PCI for 24 hours, 30 days and 1 year
Time frame: 24 hours, 30 days and 1 year
Success rate of stent implantation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2011.
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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.
Ya-Ling Han, MD principal investigator
Shenyang Northern Hospital
4 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 High dose rapamycin stent and Low dose rapamycin stent in people with Acute Coronary Syndromes, run by Shenyang Northern Hospital at 4 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 17 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-Ling Han, MD (+86-24-23922184, hanyaling.nh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA) (time frame: 270 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 17 Aug 2011.