- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03287167
Comparison One vs Six Months of Dual Antiplatelet Therapy After Implanted Firehawk TM Stent in High Bleeding Risk Patients With Coronary Artery Disease
A Prospective, Double -Blind ,Multi-center,Randomized Controled Trial of Comparison One vs Six Months of Dual Antiplatelet Therapy After Implanted Sirolimus- Eluting Stent With Abluminal Grooves Containing A Biodegradable Polymer (FirehawkTM Stent ) in High Bleeding Risk Patients With Coronary Artery Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Ming Zheng, MD
- Phone Number: (86)(21)38954600-6229
- Email: mzheng@microport.com
Study Locations
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Liaoning
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Shenyang, Liaoning, China
- Recruiting
- The General Hospital of Shenyang Military
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Contact:
- Yalin Han, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
General Inclusion Criteria:
- Age ≥ 18 years;
- Subjects (or legal guardians) understand the testing requirements and procedures, and provide written informed consent;
- Subjects could undergo percutaneous coronary intervention (PCI);
- Subjects have symptomatic coronary artery disease or have confirmed asymptomatic ischemia;
- Subjects are eligible candidates for coronary artery bypass graft surgery (CABG);
- Left ventricular ejection fraction (LVEF) within 60 days ≥ 30%;
- Subjects were willing to accept the trial plan calls for all subsequent evaluations;
Subjects can endure 6 months dual anti-platelet therapy, and met one or more criteria as the following:
1.Age ≥ 75years; 2.Subjects with hemoglobin<10g/dL, or subjects received transfusion therapy 4 weeks ago; 3.Subjects with renal insufficiency (eGFR < 60 ml / min); 4. Subjects with HAS-BLED score ≥3.0; 5.Femal patients with acute cononary syndrome; 6.BMI < 18.5 Kg/M2; 7.Subjects with congestive heart failure and with LVEF30%-50%; 8.Subjects had a history of hospitalization due to bleeding; 9.Subjects with thrombocytopenia (platelet < 100,000 / mm3); 10.Subjects had a histroy of intracranial hemorrhage; 11.Subjects had a histroy of intracranial ischemia stroke in 6 months; 12.Subjects plan to receive non-steroidal anti-inflammatory or steroid treatment for more than 30 days after the baseline PCI; 14.Subjects were expected to receive additional treatment after PCI and cannot undergo long-term DAPT therapy; 15.Subjects had a history of stomach ulcers or active ulcers.
Angiographic Inclusion Criteria
- Target lesions must be new and have a visually estimated reference diameter ≥2.25 mm and ≤4.0 mm in autologous coronary artery;
- Target lesions must be moderate-severe calcification;
- No limitations in target lesion length and number, and the number of implanted stents is less than 4;
- ALL target lesion must be able to successfully expand and implant Firehawk™ stent.
Clinical Exclusion Criteria:
Subjects recently suffer from MI (within 4 week) and ECG changes/clinical symptoms consistent with AMI, or accompanied with increased cardiac biomarkers (CK-MB, CK, TNT or TNI) and at least one of the following :
- CK-MB> 3ULN, regardless of the value of total CK;
If CK-MB or CK was not detected, but cTN> 1ULN, and at least one of the following:
- Ischemic symptoms and ECG changes of new ischemia;
- Development of pathologic Q waves in the ECG;
- Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
- Subject had Re-MI before randomized;
- Subject with hemodynamic instability (Killip class IV);
- Subjects were detected ventricular aneurysm greater than 3.0*2.0cm or intraventricular thrombosis by cardiac ultrasonography in 30 days;
- Subjects with Life-threatening arrhythmias;
- Subjects were expected to receive oral anticoagulation therapy after the baseline PCI;
- Subjects cannot endure dual anti-platelet therapy for 1 month;
- Subjects with mechanical complications after myocardial infarction;
- Subjects had an organ transplant or are waiting for an organ transplant;
- Subjects are receiving chemotherapy or will receive a chemotherapy within 30 days after PCI;
- Subjects with abnormal counts of white blood cell (WBC);
- Subjects with verified or suspected acute liver disease, including lab results of acute liver disease;
- Subjects had permanent neurological diseases in the past 6 months;
- Subjects had any PCI (such as balloon angioplasty, stent, cutting balloon) treatment in target vessels within 12 months prior to baseline;
- Non-target vessel had been implanted non-research stent 5 months ago before the baselin PCI.
- Subjects plan to undergo PCI or CABG within 1 year after the baseline PCI;
- Subjects have any coronary endovascular brachytherapy treatment previously;
- Subjects associated with drugs allergy (such as sirolimus, or structure-related compounds fluorinated polymers, thiophenepyridine or aspirin);
- Subjects are suffering from other serious illness (such as cancer, congestive heart failure), which may cause drop in life expectancy to less than 12 months;
- Subjects are currently abusing drugs (such as alcohol, cocaine, heroin, etc);
- Subject plan to undergo any operations that may lead to confuse with the programme;
- Subjects were participating in another study of drug or medical device which did not meet its primary endpoint;
- Subjects plan to pregnant within 12 months after baseline;
- Subjects are pregnant or breastfeeding women.
Angiographic Exclusion Criteria (visual estimate):
- Target lesions with the following criteria: left main, saphenous vein grafts or arterial grafts, via saphenous vein grafts or arterial graft, more than 4 stents have been implanted and in-stent sestenosis;
- Subjects with unprotected left main coronary artery disease (diameter stenosis >50%);
- Subjects have a protected left main coronary artery disease (diameter stenosis> 50% and left coronary artery bypass surgery), as well as target lesions located in the LAD and LCX;
- Subjects with other lesions of clinical significance, may be need intervention within 12 months after baseline.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 month DAPT intervention
After implantation of Firehawk coronary stents, 860 subjects in intervention group will be given dual anti-platelet therapy (DAPT) including aspirin and clopidogrel for 1 month, then will be given aspirin and placebo for next 5 months.
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Subjects will continue DAPT with clopidogrel and Aspirin (ASA) up to 1 month, after which patients will be given ASA and placebo in next 5 months and then continue on monotherapy with ASA only, unless contraindications for ASA emerge.
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Active Comparator: 6 months DAPT intervention
After implantation of Firehawk coronary stents, 860 subjects in control group will be given dual anti-platelet therapy (DAPT) including aspirin and clopidogrel for 6 months.
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Subjects will continue DAPT with clopidogrel and Aspirin (ASA) up to 6 months, after which patients will continue on monotherapy with ASA only, unless contraindications for ASA emerge.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Net Adverse Clinical and Cerebral Events (NACCE)
Time Frame: At 12 months after index procedure
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A composite of all-cause death, MI, cerebral vascular accident (CVA) and major bleeding at 18 months
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At 12 months after index procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Target Vessel Revascularization (TVR)
Time Frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
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In hospital and at 30 days,6, 12 and 24 months after index procedure
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Target lesion Revascularization (TLR)
Time Frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
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In hospital and at 30 days,6, 12 and 24 months after index procedure
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Target Vessel Failure (TVF)
Time Frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
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In hospital and at 30 days,6, 12 and 24 months after index procedure
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Target Lesion Failure (TLF)
Time Frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
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In hospital and at 30 days,6, 12 and 24 months after index procedure
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Stent Thrombosis (per ARC definition)
Time Frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
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the definite and probable stent thrombosis
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In hospital and at 30 days,6, 12 and 24 months after index procedure
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Major Adverse Cardiac and Cerebral Events(MACCE)
Time Frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
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In hospital and at 30 days,6, 12 and 24 months after index procedure
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Net Adverse Clinical and Cerebral Events (NACCE)
Time Frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
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In hospital and at 30 days,6, 12 and 24 months after index procedure
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Myocardial Infarction (MI,including Q-wave MI and non Q-wave MI)
Time Frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
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In hospital and at 30 days,6, 12 and 24 months after index procedure
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Death (All cause, Cardiac, Non-cardiac)
Time Frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
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In hospital and at 30 days,6, 12 and 24 months after index procedure
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Cardiac Death
Time Frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
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In hospital and at 30 days,6, 12 and 24 months after index procedure
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Non-Cardiac Death
Time Frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
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In hospital and at 30 days,6, 12 and 24 months after index procedure
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Major Bleeding
Time Frame: In hospital and at 30 days,6, 12 and 24 months after index procedure
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[BARC] definition
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In hospital and at 30 days,6, 12 and 24 months after index procedure
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-Effectiveness Ratio (CER)
Time Frame: At 12 months after index procedure
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CER = [total medical care costs of anti-platelet therapy] / [number of participants without net adverse clinical and cerebral events (NACCE)]
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At 12 months after index procedure
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Collaborators and Investigators
Investigators
- Principal Investigator: Yaling Han, MD, The General Hospital of Shenyang Military
Publications and helpful links
General Publications
- Capodanno D. Another Coronary Stent for Patients at High Bleeding Risk. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1884-1887. doi: 10.1016/j.jcin.2021.07.028. No abstract available.
- Lee SH, Kim J, Lefieux A, Molony D, Shin D, Hwang D, Choi KH, Chang HS, Jeon KH, Lee HJ, Jang HJ, Kim HK, Ha SJ, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Doh JH, Shin ES, Nam CW, Koo BK, Gwon HC, Lee JM. Clinical and Prognostic Impact From Objective Analysis of Post-Angioplasty Fractional Flow Reserve Pullback. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1888-1900. doi: 10.1016/j.jcin.2021.07.014.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TARGET SAFE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared. Additionally, study protocol will be available. The data will become available for the beginning 3 months and ending 5 years following article publication. The access criteria are as follow:
(With) Researchers who provide a methodologically sound proposal. (For the analysis) to achieve aims in the approved proposal. (Requisite mechanism) Proposals should be directed to mzheng@microport.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).
If the data sharing plan changes after registration, this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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