OPTIMA-AF trial

JRCT ID: jRCTs051190053

Registered date:01/10/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with non-valvular Atrial Fibrillation and Ischemic Heart Disease
• Date of first enrollment: 07/10/2019
• Target sample size: 1090
• Study type: Interventional
• Intervention(s): After eligibility criteria have been checked and written informed consent has been obtained by prior to PCI, patients who have been successfully implanted Xience will be randomized. Randomization will be concealed using web-based central randomization. Subjects will be randomized in a 1:1 fashion to either experimental arm or control arm.

Outcome(s)

Primary Outcome

The present trial has primary endpoints as follows:
1. Efficacy primary endpoint
A composite of death or thromboembolic events (All-cause death, myocardial infarction, definite stent thrombosis, stroke, or systemic embolism) at 12month (365 days).
2. Safety primary endpoint
Bleeding (ISTH major or clinically relevant nonmajor bleeding) at 12month (365 days).
Non-inferiority test for the efficacy primary endpoint (a composite of death or thromboembolic events) will be performed. When the non-inferiority test of the efficacy primary endpoint is met, superiority test for safety primary endpoint will also be performed. If it is met, superiority test will be performed for the efficacy primary endpoint.

Secondary Outcome

In this study, the following secondary endpoints will be evaluated at 1, 12 and 18 months.

1) A composite of death, thromboembolic events or bleeding
2) Bleeding per BARC criteria
BARC 2 to 5
BARC 3 to 5
All BARC
3) Bleeding per TIMI criteria
Major
Minor
Minimal
All individual components of primary endpoints including following clinical endpoints:
4) Death
All-cause death
Cardiac death
Non-cardiac death
5) Myocardial infarction according to the Third universal definition
Q wave Myocardial Infarction
Non-Q wave Myocardial Infarction
All Myocardial Infarction
Target vessel myocardial infarction
Non-target vessel myocardial infarction
6) Stent Thrombosis per ARC definition
Definite, Probable and Possible
Acute, subacute, late, very late
7) Stroke
Hemorrhagic stroke
Ischemic stroke
8) Systemic embolization
9) Target lesion revascularization
All TLR
Clinically driven TLR
Not clinically driven TLR
10) Target vessel revascularization
All TVR
Clinically driven TVR
Not clinically driven TVR
Non-target vessel revascularization
All NTVR
Clinically driven NTVR
Not clinically driven NTVR
11) All coronary revascularization

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Any PCI indication for native coronary lesions in non-valvular atrial fibrillation patients with CHADS2 score 1 or more, satisfying the following criteria:
1. Adjunctive oral anticoagulation treatment with a direct oral anticoagulant (DOAC) planned to continue after PCI
2. PCI indication for stable angina, unstable angina, and silent ischemia.
3. Subject is appropriate to be treated by PCI according to the local practice (operators judgment or heart team decision)
4. Patient is at least 20 years of age.
5. Signed Informed Consent by patient himself.
6. The patient understands and accepts clinical follow-up
Angiographic:
1. Patients with angiographically significant stenosis in de novo, native, previously unstented lesions, which is in opinion of operator appropriate to be treated by PCI.
2. Significant stenosis was defined as 90% or greater stenosis of a major epicardial vessel or proof of functional ischemic test.
3. Patients with angiographically significant stenosis, which is in opinion of operator related to symptoms of angina.

Exclude criteria

Patients who conflict with any of the following will not be included in this study.
1.Pregnant and breastfeeding women
2. Patients expected not to comply with 1-month clopidogrel or prasugrel
and DOAC
3. Patients requiring a planned staged PCI procedure more than two weeks (+14 days as occasion demands) after the index procedure
4. Patients presented with ST elevation myocardial infarction and non-ST elevation myocardial infarction
5. Active bleeding at the time of inclusion
6. Reference vessel diameter <2.25 - >5.75 mm
7. PCI for bypass graft vessel
8. Cardiogenic shock
9. Compliance with long-term DOAC alone therapy unlikely
10. Known hypersensitivity or contraindication to aspirin, clopidogrel, prasugrel, DOAC, cobalt chromium, everolimus, or a sensitivity to contrast media, which cannot be adequately avoided by pre-medication
11. PCI during the previous 6 months for a lesion other than the target lesion of the index procedure
12. Participation in another clinical trial (up to 12 months after index procedure) or already participated.
13. Patients with a life expectancy of < 1 year (12month)
14. Known severe renal insufficiency (e.g., Creatinine clearance <15 mL/min or subject on dialysis).
15. Patients inappropriate for the study participation in the opinion of the investigators

Related Information

• Primary Sponsor: Sakata Yasushi
• Secondary Sponsor: Sotomi Yohei,Kozuma Ken
• Source(s) of Monetary Support: Abbott Medical Japan LLC
• Secondary ID(s): Nil known