Comparison One vs Six Months of Dual Antiplatelet Therapy After Implanted Firehawk TM Stent in High Bleeding Risk Patients With Coronary Artery Disease

NCT03287167 | Unknown Phase 4 DMC

• 1 other identifier: TARGET SAFE
• Study Type: interventional
• Target: 1,720
• Locations: 1 country
• Sites: 1

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 -eluting stent with abluminal grooves containing a biodegradable polymer in High Bleeding Risk patients with coronary artery disease.

Conditions

Coronary Disease; Drug Eluting Stent; Percutaneous Coronary Intervention; Dual Antiplatelet Therapy

Outcome Measures

Primary Outcomes (1)

• Net Adverse Clinical and Cerebral Events (NACCE)

  A composite of all-cause death, MI, cerebral vascular accident (CVA) and major bleeding at 18 months

  At 12 months after index procedure

Secondary Outcomes (12)

• Target Vessel Revascularization (TVR)

  In hospital and at 30 days,6, 12 and 24 months after index procedure

• Target lesion Revascularization (TLR)

  In hospital and at 30 days,6, 12 and 24 months after index procedure

• Target Vessel Failure (TVF)

  In hospital and at 30 days,6, 12 and 24 months after index procedure

• Target Lesion Failure (TLF)

  In hospital and at 30 days,6, 12 and 24 months after index procedure

• Stent Thrombosis (per ARC definition)

  In hospital and at 30 days,6, 12 and 24 months after index procedure

Other Outcomes (1)

• Cost-Effectiveness Ratio (CER)

  At 12 months after index procedure

Study Arms (2)

1 month DAPT intervention

EXPERIMENTAL

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.

Drug: 1 month DAPT

6 months DAPT intervention

ACTIVE COMPARATOR

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.

Drug: 6 months DAPT

Interventions

1 month DAPT DRUG

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.

1 month DAPT intervention

6 months DAPT DRUG

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.

6 months DAPT intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai MicroPort Medical (Group) Co., Ltd.: lead

Study Sites (1)

The General Hospital of Shenyang Military

Shenyang, Liaoning, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 34503739 DERIVED

• 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.

  PMID: 34503738 DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yaling Han, MD

  The General Hospital of Shenyang Military

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Zheng, MD

CONTACT

(86)(21)38954600-6229; mzheng@microport.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 19, 2017
• Study Start: June 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 30, 2023
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 1 months and ending 5 years following article publication
• Access Criteria: (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).

Locations

CN (1)