OPTIMA-AF trial

Not Applicable

Recruiting

• Conditions: Patients with non-valvular Atrial Fibrillation and Ischemic Heart Disease; Non-valvular atrial fibrillation; ischemic heart disease; oral anticoagulant; antiplatelet therapy.

• Registration Number: JPRN-jRCTs051190053
• Lead Sponsor: Sakata Yasushi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1090

Inclusion 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.

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The present trial has primary endpoints as follows:<br>1. Efficacy primary endpoint<br>A composite of death or thromboembolic events (All-cause death, myocardial infarction, definite stent thrombosis, stroke, or systemic embolism) at 12month (365 days).<br>2. Safety primary endpoint<br>Bleeding (ISTH major or clinically relevant nonmajor bleeding) at 12month (365 days). <br>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.