Comparison Three vs Twelve Months of Dual Anti-Platelet Therapy After Stent Implantation

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a prospective,multi-center, open-label, randomized controlled clinical trial,aims to assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of Dual Anti-Platelet Therapy (DAPT) in patients undergoing percutaneous coronary intervention implanted sirolimus target- eluting stent with abluminal grooves containing a biodegradable polymer (Firehawk™ stent). All participants met the inclusion criteria begin taking aspirin and open-label thienopyridine therapy before index procedure, and will be 1:1 randomized to 3 months or 12 month of DAPT at index procedure.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
• Treatments: Aspirin; Clopidogrel; Ticagrelor; Ticlopidine

Criteria

General Inclusion Criteria:

• Age ≥ 18 years;

• Subjects (or legal guardians) understand the testing requirements and procedures, and provide written informed consent;

• Subjects with symptomatic coronary artery disease or confirmed asymptomatic ischemia;

• Target lesion should be new lesion with visually estimated reference diameter ≥2.5 mm and ≤4.0 mm in autologous coronary artery;

• Subjects willing to accept PCI therapy and to implant Firehawk™ stent only;

• Left ventricular ejection fraction (LVEF) ≥ 30%;

• Subjects willing to accept the trial plan calls for all subsequent evaluations.

Angiographic Inclusion Criteria:

• Target lesions must be new and have a visually estimated reference diameter ≥2.5 mm and ≤4.0 mm in autologous coronary artery;

• No limitations in target lesion length and number;

• The first target lesion must be able to successfully expand and implant Firehawk™ stent.

Clinical Exclusion Criteria:

• Subjects with ST-segment elevation myocardial infarction:

• Subjects having an organ transplant or waiting for an organ transplant

• Subjects receiving chemotherapy or going to receive a chemotherapy within 30 days after PCI

• Subjects undergoing chronic (over 72 hours) anticoagulant therapy (such as heparin and coumarin) other than acute coronary syndrome

• Subjects with abnormal counts of platelet and white blood cell (WBC) (investigator assess clinical significance combine normal reference range of laboratory)

• Subjects with confirmed or suspected liver disease, including hepatitis lab results

• Subjects with elevated serum creatinine level >3.0mg/dL or undergoing dialysis therapy

• Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy, or refused a blood transfusion

• Subjects with cerebral vascular accident (CVA) or transient ischemic attack (TIA) in the past 6 months, or with permanent nerve defects

• Subjects undergoing any PCI treatment in target vessels within 12 months prior to baseline

• Subjects planned to undergo PCI or CABG within 18 months after the baseline PCI

• Subjects with a history of any coronary endovascular brachytherapy treatment previously

• Subjects associated with drugs allergy (such as sirolimus, or structure-related compounds fluorinated polymers, thienopyridine or aspirin)

• Subjects being suffered from other serious illness (such as cancer, congestive heart failure), which may cause drop in life expectancy to less than 18 months

• Subjects with a history of drug abuse (such as alcohol, cocaine, heroin, etc.)

• Subject planned to undergo any operations that may lead to confuse with the programme

• Subjects participating in another study of drug or medical device which did not meet its primary endpoint

• Subjects planned to pregnant within 18 months after baseline

• Pregnant or breastfeeding women

Angiographic Exclusion Criteria:

• Target lesions with the following criteria: left main, saphenous vein grafts or arterial grafts, via saphenous vein grafts or arterial graft, and in-stent restenosis;

• Subjects with unprotected left main coronary artery disease (diameter stenosis >50%);

• Protected left main coronary artery disease(diameter stenosis >50% and undergoing CABG)with target lesions located in left anterior descending artery and left circumflex artery;

• Additional lesions of clinical significance possibly needing interventional within 18 months after enrollment..