Status:
UNKNOWN
Comparison One vs Six Months of Dual Antiplatelet Therapy After Implanted Firehawk TM Stent in High Bleeding Risk Patients With Coronary Artery Disease
Lead Sponsor:
Shanghai MicroPort Medical (Group) Co., Ltd.
Conditions:
Coronary Disease
Drug Eluting Stent
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is to assess the clinical non-inferiority of 1 month (short-term) vs 6 months (long-term) of dual anti-platelet therapy in patients undergoing percutaneous intervention implanted sirolimus ...
Detailed Description
This is a prospective, double -blind,multi-center,randomized controlled trial. Approximately 1,720 subjects in high bleeding risk with coronary artery disease will be enrolled in no more than 40 resea...
Eligibility Criteria
Inclusion
- General
- 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:
- 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
- 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.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2023
Estimated Enrollment :
1720 Patients enrolled
Trial Details
Trial ID
NCT03287167
Start Date
June 1 2019
End Date
July 30 2023
Last Update
September 9 2020
Active Locations (1)
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1
The General Hospital of Shenyang Military
Shenyang, Liaoning, China